Crispr Therapeutics AG (CRSP) Receives a Buy from Wells Fargo – Analyst Ratings
Wells Fargo analyst Jim Birchenough maintained a Buy rating on Crispr Therapeutics AG (CRSP Research Report) yesterday. The companys shares closed last Monday at $72.37, close to its 52-week high of $74.00.
According to TipRanks.com, Birchenough is a 5-star analyst with an average return of 21.4% and a 51.0% success rate. Birchenough covers the Healthcare sector, focusing on stocks such as Global Blood Therapeutics, Ionis Pharmaceuticals, and Akcea Therapeutics.
Crispr Therapeutics AG has an analyst consensus of Moderate Buy, with a price target consensus of $75.83, implying a 6.1% upside from current levels. In a report issued on November 25, Oppenheimer also maintained a Buy rating on the stock with a $80.00 price target.
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The company has a one-year high of $74.00 and a one-year low of $22.22. Currently, Crispr Therapeutics AG has an average volume of 871.2K.
TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.
CRISPR Therapeutics AG engages in the development and commercialization of therapies derived from genome-editing technology. Its proprietary platform CRISPR/Cas9-based therapeutics allows for precise and directed changes to genomic DNA. The company was founded by Rodger Novak, Emmanuelle Charpentier, and Shaun Patrick Foy in 2014 and is headquartered in Zug, Switzerland.
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Crispr Therapeutics AG (CRSP) Receives a Buy from Wells Fargo - Analyst Ratings
Recommendation and review posted by Bethany Smith
Erectile dysfunction: When he’s (not) in the mood for love – AsiaOne
Men are often portrayed as wanting to have sex all the time. In reality, a sluggish sex drive is something many men deal with at some point in their lives.
Several studies, including the often-cited Massachusetts Male Ageing Study from the University of Boston (conducted between 1987 and 1989), suggest erectile dysfunction affects more than half of all men to some degree, and is more prevalent in older men.
A low libido does not just take a toll on a man's emotional well-being; it can affect his partner and relationship, too, says Dr Angela Tan, a Singapore-based family doctor and intimacy coach.
"For starters, your male partner may feel that he is not satisfying you, and this may make him feel inadequate. It may also affect his identity and how he sees himself as a man. And if your once fulfilling sex life is now non-existent or no longer making you happy, you may wonder if [he] is attracted to you any more. This may create problems like anger and resentment, and may even lead to arguments and affairs later."
To help your partner and prevent misunderstandings, it is useful to know what may be affecting his libido.
According to Dr Colin Teo Chang Peng, a urologist at Colin Teo Urology in Singapore, one of the top causes of a low libido in men is low testosterone.
This is sometimes referred to as andropause or male "manopause", testosterone deficiency syndrome (TDS) or late onset hypogonadism (LOH).
"A man's testosterone levels start to decrease at a rate of about one per cent to two per cent every year from the age of 40," Teo explains.
"While testosterone is essential to sexual health and libido, it is also a metabolic hormone that has an effect on a man's blood-sugar control, cardiac health, psychological well-being, motivational drive, memory and physical fitness."
Low testosterone is also commonly linked with other medical conditions such as diabetes, hypertension, metabolic syndrome, coronary heart disease, obesity and renal failure, he adds.
An online survey of more than 5,000 men revealed that male sexual desire is complex and cannot be reduced to a single equation.
The researchers behind the European survey found that low confidence in their ability to achieve and maintain an erection, a lack of attraction to their partner, and being in a long-term relationship were some of the factors associated with the respondents' low sex drive. The results were published in 2014 in medical journal The Journal of Sexual Medicine.
There may be other reasons your partner cannot get in the mood for sex. Tan says that these may be medical - brain conditions like stroke, for instance; conditions that require chemotherapy, like cancer, which may deflate him emotionally; and liver problems that can cause hormonal issues.
Depression and anxiety disorder are also known to be mood killers.
If your partner is on medication, for instance some types of antidepressants and antipsychotics, he may experience a low libido, too. Even alcohol can decrease his sexual desire.
"Other causes may be related to your man's lifestyle - he may be stressed at work or under financial stress, for example; or perhaps his relationship with you feels strained, and that is affecting his desire to have sex with you," Tan says.
"Some men also have certain cultural or religious beliefs and values that may influence their views on sex, which may in turn dampen their libido."
Many men feel uneasy discussing their lack of sexual desire, especially in Asian societies, where talking about sex is considered taboo. However, Teo believes that this is slowly changing, with more men seeking their doctors' advice.
"The culture seems to be a bit more open now," he says. "More patients and doctors are aware that many sexual problems are also medical conditions. They also know that these conditions can be treated safely and effectively. We do see more men consulting their doctors about low libido and other andropause symptoms like lethargy, and many of these patients are accompanied by their partners."
The men who seek Teo's advice as soon as they notice symptoms tend to be in their 40s and 50s, leading fast-paced lives at or near the peak of their careers. A decline in their work, fitness or sexual performance is usually what motivates them to look for solutions to help restore their quality of life.
Patients who do not have fast-paced, active or career-driven lives may not notice the effects of andropause straight away and often take a while to ask their doctor for help.
It is not easy broaching the subject of low sex drive with your man, but you should not sweep the issue under the carpet, either. Tan suggests communicating your concerns in a calm, positive and non-threatening manner.
"Communication is key in this kind of situation," Tan says. "You want to be honest but not rude, and what you should not do is blame your partner or yourself, as this can have a detrimental effect on your relationship as well as your and your man's emotional well-being."
Tan advises couples to get professional help to determine the cause of a man's low sex drive and then explore ways to solve it together.
In the meantime, she says it is still possible to be intimate and maintain your physical and emotional connection, by cuddling and engaging in oral sex. Your man can also satisfy you using sex toys.
Fortunately, there are many solutions to help men get their sex lives back on track. Teo says that when a patient complains about andropause symptoms and his testosterone levels are found to be below normal, he is diagnosed with TDS and advised to begin testosterone replacement therapy (TRT).
Safe and effective, this treatment can be delivered orally with capsules, through the skin with daily gel applications, or as an injection every three months.
If the patient also has a chronic medical condition, he will be advised to undergo treatment for it, as the condition may impact his libido.
"Once testosterone levels are restored, other sexual dysfunctions can be actively remedied," says Teo. "These include erectile dysfunction, which can be treated with erectogenic medications in the form of oral tablets, injectables, and the recently available low-intensity shock wave therapy [LIST]."
In LIST, a wand-like device delivers mild shock waves to the penis that assists in the growth of new blood vessels.
Teo adds that, for patients with premature ejaculation, oral medications can help, giving the patient better control and helping the couple achieve satisfaction during sex.
In cases that do not respond to drugs or other therapies, penile implant surgery is a popular option.
A holistic approach is key when addressing low libido, so it may be necessary to include other forms of treatment, such as psychotherapy and couples' counselling.
Ultimately, while all forms of sexual dysfunction can be treated, Teo says a healthy lifestyle goes a long way towards helping men enjoy a satisfying sexual relationship.
"Exercising regularly relaxes the body and triggers the release of feel-good chemicals called endorphins, which boost your emotional well-being, while eating wholesome foods can counter some of the symptoms of andropause. You should also keep any chronic medical conditions in check and work towards strengthening your relationship with your partner."
This article was first published inSouth China Morning Post.
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Erectile dysfunction: When he's (not) in the mood for love - AsiaOne
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Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational – Financial Post
TORONTO Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that the revised commercial partnership agreement with Aytu Bioscience (Aytu) to accelerate the growth of NATESTO in the United States is now closed and fully effective as of December 1, 2019. Both parties have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of USD 10 million on or before the end of January 2020, enabling Acerus to launch a U.S.-based specialty sales force, which will promote NATESTO to urologists and endocrinologists. Aytu will continue to book all NATESTO revenue in the United States and they will promote NATESTO to all other specialties including internal medicine and family practice.
To accelerate the launch of Acerus U.S. commercial team, Aytu has agreed to transfer 5 current sales personnel to Acerus as of December 2, 2019. These staff will operate as Acerus employees but they will remain on Aytus payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Aytu will deduct the costs of these sales personnel from quarterly payments otherwise owed to Acerus under the revised agreement, with a final accounting to be done once per year. Throughout 2020, Acerus will be building out a complete US-based specialty care sales force and other commercial functions, significantly increasing the number of employees working directly on NATESTO in the United States.
This co-promotion is expected to significantly increase sales force coverage of targeted U.S. prescribers, putting a higher promotional focus on urologists and endocrinologists, while enabling Aytu to focus its promotional efforts in primary care and other specialties.
Acerus is extremely pleased to see our revised partnership with Aytu moving to execution mode as we strongly believe that the performance of NATESTO in the U.S. will benefit from an enhanced commercial focus on urology and endocrinology, said Ed Gudaitis, President and Chief Executive Officer of Acerus. We are happy to welcome the former Aytu staff to the Acerus team. With this revised partnership, Acerus is effectively pivoting its focus of effort to the U.S. NATESTO opportunity. As such, we have implemented a resource reallocation program within our Canadian office that has led to a greater than 50% reduction in headcount so that we can align our SG&A spend appropriately.
On July 29, 2019 the companies agreed to expand their commercial partnership and amend and restate the original 2016 NATESTO exclusive U.S. license agreement. Under the terms of the new agreement, Aytu returns the NDA for NATESTO in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists (Acerus Sales Channel). Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels.
To establish a high performing commercial footprint in the U.S., Acerus has engaged Syneos Health (NASDAQ: SYNH), a leading integrated biopharmaceutical solutions organization including the industrys largest Contract Commercial Organization (CCO), to be its commercialization partner. Syneos Health has extensive experience in Mens Health and with NATESTO, and offers an end-to-end model that will enable Acerus to rapidly stand up a U.S. commercial team; to scale across all aspects of commercialization, including medical and regulatory affairs, managed markets, marketing and sales; and will provide greater flexibility and effectiveness in resource deployment.
Low testosterone is estimated to affect approximately 39% of men over 45 years old in the U.S.; however, because the condition is underdiagnosed the overall prevalence is uncertain1. While patients have access to other treatment options, NATESTO is unique in that it is administered in seconds via a convenient and simple nasal gel applicator, addressing the risk of testosterone transference associated with other topical products, which carry black box warnings on their product labels.
About NATESTO (Testosterone) Nasal Gel
NATESTO is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a no-touch dispenser with a metered dose pump. A copy of the NATESTO Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO /default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO .com.
About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of mens health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.
Acerus shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO in the United States, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 4, 2019 which is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
1 Mulligan T, Frick MF, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762769
View source version on businesswire.com: https://www.businesswire.com/news/home/20191202005215/en/
Contacts
Media: Edward Gudaitis President and Chief Executive Officer egudaitis@aceruspharma.com (905) 817-8194
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Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational - Financial Post
Recommendation and review posted by Bethany Smith
Transitioning: a threat to our children – Spiked
Over the past decade there has been a huge rise in the number of young people seeking treatment for gender dysphoria a condition in which one experiences a mismatch between ones biological sex and ones gender identity. In fact, since 2008/9, there has been a 5,337 per cent increase in referrals of teen girls, and a 1,460 per cent increase in referrals of teen boys, to the Tavistock Clinic, the UKs leading treatment centre for gender dysphoria.
Many of these young people are reported to be already suffering from serious mental health issues, and sometimes a history of self-harm. So they certainly require care. What they dont require is a potential diagnosis of gender dysphoria. The consequences can be severe. As one doctor puts it, it can mean that vulnerable teens are given puberty-blocking hormones in a context of profound scientific ignorance. These hormone-blockers suppress the release of testosterone in boys and oestrogen in girls. And they are often followed by cross-sex hormone therapy.
Many who have undergone such treatment report side-effects of physical pain, depression and suicidal thoughts. Indeed, a study produced by the Tavistock Clinic, in July this year, showed that after a year on puberty-blocking hormones, patients reported a rise in suicidal and self-harming thoughts. But these findings were brushed aside. The Tavistock Clinic now offers powerful hormones to children aged 11.
Staff at the Tavistock Clinic have understandably become worried. Five clinicians have resigned, voicing concerns that children were being rushed into hormone therapy, and that trans lobby groups had pressured doctors to medicate healthy children. Experimental treatment is being done not only on children, explained one of the ex-clinicians, but very vulnerable children, who have experienced mental-health difficulties, abuse, family trauma, but sometimes those [other factors] just get whitewashed.
Trans activists claim that puberty-blocking hormones buy time for young people to find out who they really are. They claim that the high level of self-harm and attempted suicide among trans teens is due to discrimination, transphobia and delays in hormone treatment.
But it is the diagnosis and treatment itself that is the real problem. Certainly the UK health authorities warn of the rare, potential side-effects of hormone blockers, such as blood clots or cardiovascular problems. They should also warn of the serious mental-health risks of taking these drugs.
Take the widely used puberty-blocker Lupron (also known as Leuprorelin in the UK). Having been used as a cancer drug for years, it is now used for girls who wish to transition to boys. It can have devastating side-effects, including extreme mood swings, depression and suicidal thoughts. Not to mention the crushing muscle pain and nausea.
So harmful has Lupron proved that in the US the drugs manufacturer has faced lawsuits and a petition to congress to limit its use.
Another puberty-blocker is Histrelin, which is sold as Supprelin and used to treat precocious puberty. It is left to the manufacturer to explain that, Post-marketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. [Also] depression, including rare reports of suicidal ideation and attempt
Then theres Finastaride, a feminising hormone. The UK government warns that it risks causing major depression and suicidal thoughts.
On and on the list goes. Goserelin. Progesterone. Triptorelin. Testosterone. All can have serious impacts on mental health.
And who are the guinea pigs in this experiment? Children, many of whom have suffered from pre-existing mental-health issues, like bi-polar disorder and schizophrenia, before developing gender dysphoria.
Moreover, many are teenage girls, a generational cohort suffering from unprecedented levels of self-harm, linked to anxieties over body image and sexual pressure.
So how many self-harming trans teens could actually be depressed girls with body disorders? The answer is quite a lot. Hence many are de-transitioning back to their original bodies, and reporting that they were lied to. One well-known activist puts the plight of such girls in stark terms: Im a real live 22-year-old woman with a scarred chest and a broken voice and a five-oclock shadow because I couldnt face the idea of growing up to be a woman.
There are thousands of tragic stories like this. Yet de-transitioners are bullied by trans activists, ignored by the media, and abandoned by the NHS.
Its all too easy for troubled kids to be sucked into the trans world. They see the story of the beautiful trans model finding his or her self in his or her new body. They know that being a victim of gender dysphoria means special treatment. And they can then be sucked into a darker online world. Those who escaped talk of trans chatrooms where young people are manipulated, encouraged to take puberty-blockers and cross-sex hormones, and where suicide is discussed as an alternative to transition. One de-transitioning teenager says, the nasty stuff is so easy to find and so hard to wriggle free of.
Overuse of the internet has already been clinically linked to self-harm and suicide. But here we have trans websites actively encouraging self-harm and suicide.Teens open and exposed to such sites should not be on hormones that can cause extreme mood swings, depression or suicidal thoughts.
But far from resisting the trans lobby, the UK government has been busy following its advice. So from next year, new guidlines will tell schools to teach transgender relationships in class. And if you teach all children that they could be in the wrong body, a good number will believe it. Such an approach will cause many to go on to hormone treatment, and, with it, a life of pain and mental anguish.
And what of young gay students? Almost every long-term study shows that most who grow out of transgender feelings turn out to be gay. But as trans ideology spreads, many gay young people are now seeing transition as a way out. One doctor has even described the situation as conversion therapy for gay children.
On the other side, trans advocates assert that no one changes their mind. But the science underpinning such statements is shaky. One often-cited study follows 55 post-transition teens on their road to happiness. Yet it barely mentions the 141 participants who dropped out, or the one who died after post-surgery complications. Worse still, other studies that show that high suicide rates continue after transition are now ignored.
It seems that a vast trans marketing and lobbying campaign has changed our culture and intimidated our institutions. Young people with all kinds of mental-health issues are being told they are in the wrong body and that transition is the dream cure. Many believe it and cry out for treatment. So teenagers already at fatal risk of depression, self-harm and suicide are given huge doses of toxic hormones that can cause uncontrollable swings of emotion, anxiety and depression. The dream of being in a new and beautiful body fades. It is replaced by an agonising reality. And so many continue to self-harm. And some take their own lives.
This fate now awaits thousands more children. They should instead be left alone or given proper medical care. It might just save them.
Simon Marcus is a writer, political consultant and former government adviser.
Picture by: Getty
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Transitioning: a threat to our children - Spiked
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Most Americans find their jobs stressful here’s how to survive at work – PhillyVoice.com
Even when you love what you do, work-related stress can pile up, affecting your physical and mental health. For many people, it's a fact of life.
Each year, a majority of Americans report experiencing heavy work stress, according to theAmerican Psychological Association's annual Stress in America survey.
The most common stressors are low salaries, too much work, little room to grow or to be challenged, and lack of autonomy and support. While you can't completely eliminate stress from your life, when it becomes chronic you are putting your health in jeopardy.
When you experience a stressor, your body releases adrenaline, causing your heart rate to spike and your blood pressure to rise,according to theMayo Clinic. Cortisol, a hormone that increases blood sugar and limits functions that are not considered essential in a crisis, also increases.
This fight-or-flight drive is a natural mechanism designed to protect you from aggressors. But problems arise when you are constantly in a state of crisis.
"The long-term activation of the stress-response system and the overexposure to cortisol and other stress hormones that follows can disrupt almost all of your body's processes," according to the Mayo Clinic.
Chronic stress can lead to anxiety, high blood pressure and a weakened immune system. It can put you at higher risk for depression, obesity and heart disease. Stress also affects the quality and quantity of sleep, which in turns contributes to difficulties focusing at work.
When stress feels out of control, people sometimes turn to unhealthy coping strategies like overloading on junk food, binge drinking, smoking or taking drugs.
So short of leaving your job, how can you better manage stress and stay healthy? Here are some tips from theAmerican Psychological Association, National Sleep Foundation, Mayo Clinicand Harvard Health:
Keep track of daily stressors and how you react to them.
Then adopt new, healthier coping strategies like adding more exercise into your weekly routine, carving out more time for hobbies or spending time with loved ones.
Make sure you are getting enough sleep by having a set bedtime and by creating rituals to prepare your mind and body for sleep. That includes avoiding electronics for at least an hour before bedtime.
Set clear boundaries for your work and home life. If you are constantly bringing work home with you, you will never completely relax and de-stress.
Practice meditation and deep breathing exercises every day to build up your resilience against stress.
Work on your problem-solving skills so you stay solution-focused instead of getting mired in negative thoughts.
Finally, don't be afraid to ask for help. Talk to your supervisor about stress management resources at work, as well as ways he or she can support you better. Family and friends also can be good sounding boards.
If you continue to feel overwhelmed, a psychologist can help you create healthy coping mechanisms. You can find resources here.
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Most Americans find their jobs stressful here's how to survive at work - PhillyVoice.com
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Surgeons Transplant a Testicle From One Brother to His Twin – The New York Times
A 36-year-old man born without testicles received one transplanted from his identical twin brother in a six-hour operation performed on Tuesday in Belgrade, Serbia, by an international team of surgeons.
The surgery was intended to give the recipient more stable levels of the male hormone testosterone than injections could provide, to make his genitals more natural and more comfortable, and to enable him to father children, said Dr. Dicken Ko, a transplant surgeon and urology professor at Tufts University School of Medicine in Boston, who flew to Belgrade to help with the procedure.
The operation was only the third known transplant of this type. The first two were performed 40 years ago in St. Louis, also for identical twins, each pair with a brother lacking testicles.
The absence of testicles is an exceedingly rare condition, but doctors say that the surgery may have broader applications for transgender people, accident victims, wounded soldiers and cancer patients. But the procedure raises questions about the ethics of transplants that are not lifesaving, and about the possibility of recipients someday fathering children with sperm from donors who may not even be related to them.
The surgery was performed at the University Childrens Clinic in Tirsova, a section of Belgrade. The Serbian brothers are doing well, doctors said. By Friday, the recipient already had normal testosterone levels.
Hes good, he looks good, his brother looks good, Dr. Ko said in a telephone interview on Friday. The donor, who already has children, should remain as fertile as he was before, despite giving up a testicle.
Dr. Ko said the brothers, who have been sharing a hospital room, were expected to go home this weekend. They preferred not to be identified or interviewed, the doctors said.
Because the patients are identical twins with the same genetic makeup, there is no concern that the recipients body will reject the transplant, so he does not have to take the immune-suppressing drugs that most transplant patients need.
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Surgeons operated on the brothers simultaneously, in adjoining rooms. The procedure was challenging because it required sewing together two arteries and two veins that were less than 2 millimeters wide.
Once you remove the testicle from the donor, the clock starts ticking very fast, said Dr. Branko Bojovic, an expert in microsurgery at Harvard Medical School and part of the team in Belgrade.
Within two to four hours, you have to have it re-perfused and working again, Dr. Bojovic said. Without a blood supply, a testicle is viable for only four to six hours.
It can take 30 to 60 minutes to make each of the four blood-vessel connections. But the team managed to complete them all in less than two hours, he said.
The team did not connect a structure called the vas deferens, which carries sperm out of the testicles. The surgeons could not find the tissue in the recipient needed for the connection, which means that for now, he cannot father children in the usual way.
Another operation to make the connection may be possible. Otherwise, if the recipient wants children, he might undergo a procedure to extract sperm from the testicle for in vitro fertilization. Or his twin brothers sperm could be used.
Dr. Ko and Dr. Bojovic were both part of the surgical team that performed the first penis transplant in the United States, in 2016, on a man whose penis had been removed because of cancer.
Dr. Miroslav Djordjevic, who led the team in Belgrade, specializes in urologic reconstruction and sex reassignment surgery at Mount Sinai Hospital in New York and at the University of Belgrade. He said the brothers approached him after learning that he had performed a successful uterus transplant between twins sisters, which enabled the recipient to give birth.
Dr. Bojovic said that after the penis transplant, the surgical team received inquiries from people undergoing female-to-male sex reassignment who wondered if they might receive transplants instead of the usual surgery, which creates a penis from the patients own tissue.
But a transplant from any donor other than an identical twin would require immune-suppressing drugs to prevent rejection. The drugs have side effects that lead some experts to argue that the bar for such transplants must be very high.
Its becoming more of a popular topic for these patients, Dr. Bojovic said. They say, If immunosuppression is getting safer, I dont want to use a big piece of tissue from my forearm or thigh or back for something that looks like phallus but isnt.
He added that in patients having male-to-female reassignment surgery, the penis and testicles that were surgically removed are discarded, but in theory could be used for transplants.
The lead surgeon, Dr. Djordjevic, said that he had developed a surgical plan for transplanting a penis onto a body that is anatomically female, and that he hoped to begin performing that surgery within the next year or so.
We have to do this as soon as possible, to stop putting healthy organs in the garbage, he said.
But he would not transplant testicles as part of transgender surgery, he said. Doing so would open up the thorny possibility that the recipient could have children produced by the donors sperm. If the idea were extended to deceased organ donors, special permission would be required from them before death, or from their families.
Then the offspring is technically whose child? asked Dr. Ko, who is also chief medical officer at St. Elizabeths Hospital in Boston. It raises much debate in the literature of medical ethics.
Last year, when surgeons at Johns Hopkins Hospital transplanted a penis, scrotum and other tissue to a young soldier who had been maimed in combat, they deliberately left out the testicles. The idea that he might father children who were genetically someone elses was considered unacceptable.
The first report of a testicle transplant, by Dr. Sherman J. Silber, a fertility specialist in St. Louis, was published in a medical journal in 1978. In that case, the twin brothers were 30 when they consulted Dr. Silber.
The brother without testicles had not reached puberty until he was given testosterone at age 18, which caused a growth spurt that left him four inches taller than his brother. He needed regular testosterone injections to maintain his masculine characteristics, but the hormone levels fluctuated and sometimes caused mood swings.
He spent five years searching for a doctor who could perform a testicle transplant before he found Dr. Silber, after reading a New York Times article about his work published in 1975.
Dr. Silber said that he had performed more than 2,000 kidney transplants in rats, which required microsurgical techniques to sew together minute blood vessels the same size as those in human testicles.
So doing a testicle transplant was not a big deal, he recalled in an interview on Thursday. It was like just another kidney transplant in a rat. He said the operation took two hours.
Dr. Silber said that the donor was gay and the recipient straight, and that the brothers told him they wondered if the transplanted testicle might somehow alter the recipients sexual orientation. There is no scientific reason for such an effect, and none occurred.
The transplant was a success, and the recipient eventually had five children, Dr. Silber said. A year or so later, he performed the surgery again for another pair of identical twin brothers, though he did not write up their case in a journal.
Regarding the operation in Belgrade, Dr. Silber said, I imagine these surgeons must be pretty good, because most people wouldnt dare to try this.
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Surgeons Transplant a Testicle From One Brother to His Twin - The New York Times
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Surgeons transplant testicle from one identical twin to the other – The Independent
A 36-year-old man born without testicles received one transplanted from his identical twin brother in a six-hour operation performed in Belgrade, Serbia, by an international team of surgeons.
The surgery was intended to give the recipient more stable levels of the male hormone testosterone than injections could provide, to make his genitals more natural and more comfortable, and to enable him to father children, said DrDicken Ko, a transplant surgeon and urology professor at Tufts University School of Medicine in Boston, who flew to Belgrade to help with the procedure.
The operation was only the third known transplant of this type. The first two were performed 40 years ago in StLouis, also for identical twins, each pair with a brother lacking testicles.
Sharing the full story, not just the headlines
The absence of testicles is an exceedingly rare condition, but doctors said that the surgery may have broader applications for transgender people, accident victims, wounded soldiers and cancer patients. But the procedure raises questions about the ethics of transplants that are not lifesaving and about the possibility of recipients someday fathering children with sperm from donors who may not even be related to them.
The surgery was performed at the University Childrens Clinic in Tirsova, a section of Belgrade. The Serbian brothers are doing well, doctors said. By Friday, the recipient already had normal testosterone levels.
A vaping-related lung disease has claimed the lives of 11 people in the US in recent weeks. The US Centre for Disease Control and Prevention has more than 100 officials investigating the cause of the mystery illness, and has warned citizens against smoking e-cigarette products until more is known, particularly if modified or bought off the street
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Researchers in the US claim to have overcome one of the major hurdles to cultivating human follicles from stem cells. The new system allows cells to grow in a structured tuft and emerge from the skin
Sanford Burnham Preybs
A study in the journal Scientific Reports suggests that a dose of nature of just two hours a week is associated with better health and psychological wellbeing
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Exposure to air from traffic-clogged streets could leave women with fewer years to have children, a study has found. Italian researchers found women living in the most polluted areas were three times more likely to show signs they were running low on eggs than those who lived in cleaner surroundings, potentially triggering an earlier menopause
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Junk food adverts on TV and online could be banned before 9pm as part of Government plans to fight the "epidemic" of childhood obesity.Plans for the new watershed have been put out for public consultation in a bid to combat the growing crisis, the Department of Health and Social Care (DHSC) said
PA
On migrating from Africa around 70,000 years ago, humans bumped into the neanderthals of Eurasia. While humans were weak to the diseases of the new lands, breeding with the resident neanderthals made for a better equipped immune system
PA
The breath biopsy device is designed to detect cancer hallmarks in molecules exhaled by patients
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By their 10th birthdy, children have on average already eaten more sugar than the recommended amount for an 18 year old. The average 10 year old consumes the equivalent to 13 sugar cubes a day, 8 more than is recommended
PA
While there is not enough evidence of harm to recommend UK-wide limits on screen use, the Royal College of Paediatrics and Child Health have advised that children should avoid screens for an hour before bed time to avoid disrupting their sleep
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A study published in the New England Journal of Medicine has found that many elderly people are taking daily aspirin to little or no avail
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A study by the University of Minnesota's Masonic Cancer Centre has found that the carcinogenic chemicals formaldehyde, acrolein, and methylglyoxal are present in the saliva of E-cigarette users
Reuters
There has been a 41% increase in children with type 2 diabetes since 2014, the National Paediatric Diabetes Audit has found. Obesity is a leading cause
Reuters
The majority of antidepressants are ineffective and may be unsafe, for children and teenager with major depression, experts have warned. In what is the most comprehensive comparison of 14 commonly prescribed antidepressant drugs to date, researchers found that only one brand was more effective at relieving symptoms of depression than a placebo. Another popular drug, venlafaxine, was shown increase the risk users engaging in suicidal thoughts and attempts at suicide
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Researchers at the Baptist Health South Florida Clinic in Miami focused on seven areas of controllable heart health and found these minority groups were particularly likely to be smokers and to have poorly controlled blood sugar
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A major pressure group has issued a fresh warning about perilously high amounts of sugar in breakfast cereals, specifically those designed for children, and has said that levels have barely been cut at all in the last two and a half decades
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New guidance by the National Institute for Health and Care Excellence (NICE), the body which determines what treatment the NHS should fund, said lax road repairs and car-dominated streets were contributing to the obesity epidemic by preventing members of the public from keeping active
PA
A new class of treatments for women going through the menopause is able to reduce numbers of debilitating hot flushes by as much as three quarters in a matter of days, a trial has found.The drug used in the trial belongs to a group known as NKB antagonists (blockers), which were developed as a treatment for schizophrenia but have been sitting on a shelf unused, according to Professor Waljit Dhillo, a professor of endocrinology and metabolism
REX
Research from Oxford University found that more than one million extra people suffering from mental health problems would benefit from being prescribed drugs and criticised ideological reasons doctors use to avoid doing so.
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The family of a teenager who died from flu has urged people not to delay going to A&E if they are worried about their symptoms. Melissa Whiteley, an 18-year-old engineering student from Hanford in Stoke-on-Trent, fell ill at Christmas and died in hospital a month later.
Just Giving
The Government has pledged to review tens of thousands of cases where women have been given harmful vaginal mesh implants.
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The NHS will be asked to go further to prevent the deaths of patients in its care as part of a zero suicide ambition being launched today
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Human trials have begun with a new cancer therapy that can prime the immune system to eradicate tumours. The treatment, that works similarly to a vaccine, is a combination of two existing drugs, of which tiny amounts are injected into the solid bulk of a tumour.
Nephron
Mothers living within a kilometre of a fracking site were 25 per cent more likely to have a child born at low birth weight, which increase their chances of asthma, ADHD and other issues
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Thousands of cervical cancer screening results are under review after failings at a laboratory meant some women were incorrectly given the all-clear. A number of women have already been told to contact their doctors following the identification of procedural issues in the service provided by Pathology First Laboratory.
Rex
Most breast cancer patients do not die from their initial tumour, but from secondary malignant growths (metastases), where cancer cells are able to enter the blood and survive to invade new sites. Asparagine, a molecule named after asparagus where it was first identified in high quantities, has now been shown to be an essential ingredient for tumour cells to gain these migratory properties.
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A record number of nursing and midwifery positions are currently being advertised by the NHS, with more than 34,000 positions currently vacant, according to the latest data. Demand for nurses was 19 per cent higher between July and September 2017 than the same period two years ago.
REX
CBD has a broadly opposite effect to delta-9-tetrahydrocannabinol (THC), the main active component in cannabis and the substance that causes paranoia and anxiety.
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Mr Bransons company sued the NHS last year after it lost out on an 82m contract to provide childrens health services across Surrey, citing concerns over serious flaws in the way the contract was awarded
PA
The numbers of people accepted to study nursing in England fell 3 per cent in 2017, while the numbers accepted in Wales and Scotland, where the bursaries were kept, increased 8.4 per cent and 8 per cent respectively
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The paper found that there were 45,000 more deaths in the first four years of Tory-led efficiencies than would have been expected if funding had stayed at pre-election levels.On this trajectory that could rise to nearly 200,000 excess deaths by the end of 2020, even with the extra funding that has been earmarked for public sector services this year.
Reuters
Hours of commuting may be mind-numbingly dull, but new research shows that it might also be having an adverse effect on both your health and performance at work. Longer commutes also appear to have a significant impact on mental wellbeing, with those commuting longer 33 per cent more likely to suffer from depression
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It is not possible to be overweight and healthy, a major new study has concluded. The study of 3.5 million Britons found that even metabolically healthy obese people are still at a higher risk of heart disease or a stroke than those with a normal weight range
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When you feel particularly exhausted, it can definitely feel like you are also lacking in brain capacity. Now, a new study has suggested this could be because chronic sleep deprivation can actually cause the brain to eat itself
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David Lloyd Gyms have launched a new health and fitness class which is essentially a bunch of people taking a nap for 45 minutes. The fitness group was spurred to launch the napercise class after research revealed 86 per cent of parents said they were fatigued. The class is therefore predominantly aimed at parents but you actually do not have to have children to take part
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Tobacco and alcohol companies could win more easily in court cases such as the recent battle over plain cigarette packaging if the EU Charter of Fundamental Rights is abandoned, a barrister and public health professor have said
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A major new study into the side effects of the cholesterol-lowering medicine suggests common symptoms such as muscle pain and weakness are not caused by the drugs themselves
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New research has found that babies born to fathers under the age of 25 or over 51 are at higher risk of developing autism and other social disorders. The study, conducted by the Seaver Autism Center for Research and Treatment at Mount Sinai, found that these children are actually more advanced than their peers as infants, but then fall behind by the time they hit their teenage years
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Commuters who swap their car or bus pass for a bike could cut their risk of developing heart disease and cancer by almost half, new research suggests but campaigners have warned there is still an urgent need to improve road conditions for cyclists.Cycling to work is linked to a lower risk of developing cancer by 45 per cent and cardiovascular disease by 46 per cent, according to a study of a quarter of a million people.Walking to work also brought health benefits, the University of Glasgow researchers found, but not to the same degree as cycling.
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Scientists conducted the research on 71 car crash victims as they were waiting for treatment at one hospitals accident and emergency department. They asked half of the patients to briefly recall the incident and then play the classic computer game, the others were given a written activity to complete. The researchers, from Karolinska Institute in Sweden and the University of Oxford, found that the patients who had played Tetris reported fewer intrusive memories, commonly known as flashbacks, in the week that followed
Rex
Vaping has been given an emphatic thumbs up by health experts after the first long-term study of its effects in ex-smokers.After six months, people who switched from real to e-cigarettes had far fewer toxins and cancer-causing substances in their bodies than continual smokers, scientists found
Matt Cardy/Getty Images
Millions of people are putting themselves at risk by cooking their rice incorrectly, scientists have warned.Recent experiments show a common method of cooking rice simply boiling it in a pan until the water has steamed out can expose those who eat it to traces of the poison arsenic, which contaminates rice while it is growing as a result of industrial toxins and pesticides
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An injectable contraceptive gel that acts as a reversible vasectomy is a step closer to being offered to men following successful trials on monkeys.Vasalgel is injected into the vas deferens, the small duct between the testicles and the urethra. It has so far been found to prevent 100 per cent of conceptions
Vasalgel
Women who work at night or do irregular shifts may experience a decline in fertility, a new study has found.Shift and night workers had fewer eggs capable of developing into healthy embryos than those who work regular daytime hours, according to researchers at Harvard University
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The Japanese government has announced measures to limit the amount of overtime employees can do in an attempt to stop people literally working themselves to death.A fifth of Japans workforce are at risk of death by overwork, known as karoshi, as they work more than 80 hours of overtime each month, according to a government survey.
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It is well known that high blood pressure is a risk factor for dementia, so the results of a new study from the University of California, Irvine, are quite surprising. The researchers found that people who developed high blood pressure between the ages of 80-89 are less likely to develop Alzheimers disease (the most common form of dementia) over the next three years than people of the same age with normal blood pressure.
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A vaping-related lung disease has claimed the lives of 11 people in the US in recent weeks. The US Centre for Disease Control and Prevention has more than 100 officials investigating the cause of the mystery illness, and has warned citizens against smoking e-cigarette products until more is known, particularly if modified or bought off the street
Getty
Researchers in the US claim to have overcome one of the major hurdles to cultivating human follicles from stem cells. The new system allows cells to grow in a structured tuft and emerge from the skin
Sanford Burnham Preybs
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Surgeons transplant testicle from one identical twin to the other - The Independent
Recommendation and review posted by Bethany Smith
Health Department announces services for the week of Dec 9 – Canton Daily Ledger
The Fulton County Health Department has scheduled the following health clinics and services.
CANTON The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.
Maternal child health: Health screenings, WIC nutrition education and supplemental food coupons for women, infants and children. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria clinic appointments call 329-2922.
Canton - Clinic - Monday, Dec. 9 - 8-4 - Appt needed
Canton - WIC Nutrition Education - Tuesday, Dec. 10 - 8-4 - Appt needed
Astoria - Clinic, WIC Nutrition Educ. - Wednesday, Dec. 11 - 9-3 - Appt needed
Canton - Clinic - Thursday, Dec. 12 - 8-4 - Appt needed
Adult Health Immunizations: Various vaccines are available. There is a fee for immunization administration. Medicaid cards are accepted. To make an appointment or for more information call 647-1134 (ext. 254).
Other times available by special arrangement at Canton, Cuba and Astoria.
Blood Lead Screening: Blood lead screenings are available for children ages one to six years. A fee is based on income. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria appointments call 329-2922.
Family Planning: Confidential family planning services are available by appointment at the Canton office for families and males of child-bearing age. Services provided include physical exams, pap smears, sexually transmitted disease testing, contraceptive methods, pregnancy testing, education and counseling. Services are available to individuals of all income levels. Fees are based on a sliding fee scale with services provided at no charge to many clients. Medicaid and many insurances are accepted. After hours appointments are available. To make an appointment or for more information call the 647-1134 (ext. 244). *Program funding includes a grant from the US DHHS Title X.
Pregnancy testing: Confidential urine pregnancy testing is available at the Canton and Astoria offices. This service is available to females of all income levels. A nominal fee is charged. No appointment is needed. A first morning urine specimen should be collected for optimal testing and brought to the health department. Services are provided on a walk-in basis on the following days each week:
Canton: Every Wednesday & Thursday, 8-3:30 (for more information call 647-1134 ext. 244)
Astoria: Every Wednesday, 9-2:30 (for more information call 329-2922)
Womens Health: A womens clinic for pap tests, clinical breast examinations and vaginal examinations is available by appointment. There is a nominal fee for this service. Medicaid cards are accepted. Financial assistance is available for a mammogram. Cardiovascular screenings may be available to age and income eligible women. To make an appointment or for more information call 647-1134 (ext. 244).
Mammograms: Age and income eligible women may receive mammograms at no charge. Speakers are available to provide information to clubs and organizations. For more information or to apply for financial assistance, call 647-1134 (ext. 254).
Mens Health: Prostate specific antigen (PSA) blood tests are available for men for a fee. To make an appointment or for more information call 647-1134 (ext. 224).
Canton - Clinic - Monday, Dec. 9 - 8-12 - Appt needed
Sexually Transmitted Disease (STD) Clinic: Confidential STD and HIV testing services are available by appointment to males and females at the Canton office. Services include physical exams to identify STDs, a variety of STD testing, HIV testing, education, counseling, medications and condoms. There is a nominal fee for services. Services are available to individuals of all income levels. Medicaid cards are accepted. To make an appointment or for more information call 746-1134 (ext. 224).
HIV Testing and Counseling: Confidential HIV testing and counseling services are available by appointment through the sexually transmitted disease (STD) clinic at the Canton office. To make an appointment or for more information call 647-1134 (ext. 224).
Tuberculosis (TB) Testing: TB skin tests are available at no charge by appointment. To make an appointment or for more information call 647-1134 (ext. 254).
Blood Pressure Screenings: The Fulton County Health Department provides blood pressure screenings at no charge on a walk-in basis during the following times:
Canton - Screening - Monday, Dec. 9 - 8-4 - Walk in/Room 108
Cuba - Screening - Monday, Dec. 9 - 8-12 - Walk in
Astoria - Screening - Wednesday, Dec. 11 - 9-12 - Walk in
Health Watch Wellness Program: The Health Watch Program provides low cost lab services. Through this program adults can obtain venous blood draws for a variety of blood tests. Blood tests offered without a doctors order Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC), Lipid Panel, Prostate Specific Antigen (PSA) test, Hepatitis C test, and Thyroid Stimulating Hormone (TSH). A wide variety of blood tests are also available with a doctors order. There is a charge at the time of service. To make an appointment or for more information call 647-1134 (ext. 254).
Canton - Clinic - Monday, Dec. 9 - 8-12 - Appt needed
Dental Services: The Dental Center offers a variety of basic dental services to children and adults. An appointment is needed. Medicaid and Kid Care cards are accepted. To make an appointment or for more information call 647-1134 (ext. 292).
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Health Department announces services for the week of Dec 9 - Canton Daily Ledger
Recommendation and review posted by Bethany Smith
Breaking down the meds you can take while breastfeeding – The Daily Collegian Online
One of the most commonly searched questions about breastfeeding is, What medicines can you take? Since everything you consume makes its way into your babys milk supply, its a valid concern. Sure, we know to pump and dump after a couple glasses of wine, but what about medications?
There are myriad benefits to breastfeeding your baby. Nursing reduces a woman and her babys risk of getting breast cancer, and the antibodies in human milk protect against infection and build the immune system. While there are many benefits, its also important that breastfeeding moms take care of their own health. Sometimes, that means taking medication. Certified Lactation Education Counselor and Certified Childbirth Educator AAHCC Liza Janda breaks down whats OK and whats off limits.
What to do before taking any medications
The most important thing a lactation educator consultant can do is educate the mother on being an active participant in her health care decisions, Janda says. Most medications are suitable to take while breastfeeding. Many mothers are told they need to stop breastfeeding to take a medication or do a test or a procedure. In most cases, this is unnecessary.
Janda recommends asking yourself and your physician important questions before taking any medications:
Are there alternatives to treatment that dont involve medication?
Is there an alternative medication that may be safer?
Do the benefits of taking the medication outweigh the risks to my baby?
In the clear
With all medications during breastfeeding, there is a risk that trace amounts will end up in your milk supply. In most cases, however, the amount is very small and will not harm your child.
Ibuprofen is generally safe for nursing women to take. A 1984 study found that moms who took 400mg of ibuprofen every six hours passed on less than 1mg to their supply, an amount that will not negatively affect your baby, but nursing women should not take more than the daily maximum dose. Of course, consult your doctor before taking.
In the way of painkillers, acetaminophen and naproxen are also OK for breastfeeding mothers. However, naproxen (Aleve, Midol, Flanax) should be used for the short-term only.
According to Planned Parenthood, it is safe to use hormonal methods of birth control while breastfeeding. These include the shot, implant, Skyla and Mirena IUDs, and some kinds of birth control pills (known as the minipill). However, methods that include the hormone estrogen (pills, patch, or ring) should be avoided for the first three weeks after giving birth. After three weeks, these hormonal methods are fair game once again.
If you have symptoms of a cold, thats where medication while breastfeeding gets tricky.
Cold medicine can affect milk supply, Janda says. If the goal of the cold remedy is to dry up a stuffy nose, it will probably also lower her milk supply.
Most decongestants like Sudafed and Zyrtec D contain pseudoephedrine, which can lower milk supply. Use medications with this ingredient with caution. For a full list on what medications are safe to take while breastfeeding, check out this guide from the Mayo Clinic.
Not so safe
Contraindicated is a medical term that means a procedure or medication is unadvisable. While breastfeeding, contraindicated drugs include anticancer drugs, lithium, oral retinoids, iodine, amiodarone, gold salts, marijuana and other recreational drugs.
If youre interested in researching a particular medication, theres ToxNet. ToxNets LactMed feature is a resource and database featuring 31 antibiotics, their safety, and the amount that shows up in breast milk. You can also search SSRIs and other meds.
Drinking, smoking, and using CBD while breastfeeding
Breastfeeding mothers can drink alcohol, but it takes 2-3 hours to metabolize one 5-ounce glass of wine, 1-2 ounces of hard liquor, and one 8-ounce of beer, Janda explains. Do not breastfeed for 2-3 hours after that one serving. If she drinks more than one serving, it will take 4-6 hours to metabolize.
Smoking nicotine is recognized as off-limits for nursing mothers, as nicotine in the milk supply can cause fussiness, diarrhea, vomiting, rapid heard beat and restlessness in infants, according to Janda.
As for CBD, the jurys still out. Theres not enough research or regulation to decide about CBD, Janda says. So, just avoid it to be safe.
If you're interested in submitting a Letter to the Editor, click here.
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Breaking down the meds you can take while breastfeeding - The Daily Collegian Online
Recommendation and review posted by Bethany Smith
Scientific achievements of 2019 – The – The Institute of Cancer Research
Image: Drugs for a clinical trial
The ICRs researchers showed that a new immunotherapy could greatly extend the lives of people with advanced head and neck cancer, with some living for over three years.
They evaluated the drug pembrolizumab in a trial of nearly 500 patients with very advanced disease that had already spread and become resistant to chemotherapy.
Treatment options for these patients are extremely limited, and they are normally expected to survive for less than six months.
Overall, patients who received pembrolizumab experienced significant benefits with 37 per cent surviving for a year or more, compared with only 26.5 per cent of those on standard care, consisting of chemotherapy or the targeted agent cetuximab.
Some 36 patients saw their cancer partially or completely disappear, and some were still cancer-free three years after first receiving pembrolizumab.
Study leader Professor Kevin Harrington, Professor of Biological Cancer Therapies at The ICR and Consultant at The Royal Marsden, said:
I would like to see pembrolizumab approved for use in the clinic, so that people with metastatic head and neck cancer can be offered the chance of a longer life and improved quality of life.
The trial, published in The Lancet, was funded byMerck & Co., Inc.
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Scientific achievements of 2019 - The - The Institute of Cancer Research
Recommendation and review posted by Bethany Smith
New test predicts chance of living more than a year on targeted breast cancer treatment – The Institute of Cancer Research
Image:Breast cancer cells stained for DNA (red), NFkB (green), and a reactive oxygen species probe (blue). Credit: Julia Sero / the ICR, 2011
A new test could pick out women with advanced breast cancerwho are likely to benefit from an exciting new targeted therapy for more than a year.
Analysing levels of a molecule called cyclin E1 in tumour biopsies could be used to guide breast cancer treatment helping delay chemotherapy for some women and ensuring others are closely monitored for any signs of progression.
Researchers found that testing for cyclin E1 could predict the chances of a year or more of successful treatment with a drug called palbociclib a drug hailed by doctors as the biggest advance in breast cancer treatment for 20 years.
Palbociclib targets weaknesses in cancer cells specifically, and so has far fewer side-effects than conventional chemotherapy allowing women to live well with their cancer.
It comes as NICE last week recommendedthe use of palbociclib on the NHS through the Cancer Drugs Fund, for women with advanced oestrogen receptor-positive breast cancer who have received hormone therapy.
Hormone therapy works against around 70 per cent of breast cancers and is one of the most common first treatments for people with advanced breast cancer so the new approval could significantly increase the number of women who can benefit from palbociclib on the NHS.
The study by the team at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, showed that women with low levels of cyclin E1 in their tumours responded to palbociclib given in combination with hormone treatment for nearly twice as long as women with high levels.
The tests development is described in a study in the Journal of Clinical Oncology with funding by palbociclibs manufacturer, Pfizer.
Following her initial breast cancer diagnosis and successful treatment in 2012, Christine was shocked to discover that her cancer had spread to her brain in 2018. Thanks to palbociclib, Christine is now living well with cancer, including a new-found passion for cycling.
Read Christine's story
The study found that the combination of palbociclib and hormone treatment had some benefit for women irrespective of their test results, delaying the need for chemotherapy for at least three months, even in the shortest responders.
But the researchers suggest that women with higher levels of cyclin E1 in their tumours should be monitored especially closely, since they can be expected to stop responding much more quickly than others.
Researchers in the Breast Cancer Now Toby Robins Research Centreat The Institute of Cancer Research (ICR) looked at tumour samples from two different trials involving palbociclib 302 patients from PALOMA-3, a trial which assessed the drug in combination with hormone therapy for advanced cancer, and the POP trial which looked at palbociclib used on its own before surgery in 61 patients with breast cancers that hadnt yet spread.
In the PALOMA-3 trial, women with low levels of cyclin E1 responded to combination treatment for an average of 14.1 months before their tumour started growing again, compared with only 7.6 months in women with high levels, and 4 months among those who received a placebo plus hormone therapy.
In the POP trial, palbociclib treatment stopped the tumour growing in 80 per cent of women if low levels of cyclin E1 were present, whereas palbociclib only stopped the tumour growing in 36 per cent of women it high levels of cyclin E1 were present.
Strategies to overcome cancers lethal ability to survive and resist treatment are a major focus by researchers at the ICR, who are poised to outsmart cancer with the worlds first anti-evolution Darwinian drug discovery programme.
To facilitate this, the research institution is constructing a 75 million state of the art building the Centre for Cancer Drug Discovery. It will house a series of pioneering projects to deliver long-term control and effective cures, just as comparable approaches have achieved with HIV.
Palbociclib targets two proteins called CDK4 and CDK6 that are involved in a series of checks that control when a cell can replicate its DNA. By blocking these two proteins from doing their jobs, cancer cells cant multiply.
Cyclin E1 is also involved in the checkpoints that dictate when a cell can multiply, and the researchers hypothesise that high levels of cyclin E1 allow cells to bypass other checks and keep multiplying, uncontrolled.
Previous studies hadnt been able to identify a marker which indicated how successful palbociclib would be, or to spot resistance arising, so the team widened the search and analysed the activity of 2,534 different cancer-related genes.
Cyclin E1 appeared to be the most significant predictive indicator of how a patient will respond to palbociclib, and they identified possible others including associated protein CDK2.
Interestingly, the effect of cyclin E1 on treatment response was stronger in biopsies from metastatic tumours than primary tumour biopsies taken at diagnosis.
The difference highlights the importance of taking biopsies of recurrent breast cancer to guide treatment as tumours evolve to become drug resistant.
Although the researchers show cyclin E1 is an indicator of response to palbociclib in two different treatment settings, it will still need to be validated as a test to guide treatment in clinical trials designed specifically to assess its success.
Professor Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said:
Palbociclib is a targeted drug that allows women to live a normal life for longer but when their cancer evolves and develops resistance, they can stop responding to the treatment.
Weve developed a way of identifying which women with advanced breast cancer stand to benefit for more than a year from the targeted treatment palbociclib, and which are likely to stop responding much more quickly.
Nearly all the women on the PALOMA-3 trial benefited from the drug for at least a few months, delaying the need for chemotherapy. But some women will progress more quickly, and may require additional monitoring so we can switch treatments as soon as the drug stops working.
We validated our findings using data from a second trial, but we will need to assess our test further to see how effectively it can guide treatment before it could start to be used routinely in patients.
Christine OConnell, 46, from south-west London, was diagnosed with secondary breast cancer in February 2018. She said:
I have seen first-hand the difference a targeted treatment can make. Im on the 19th cycle of palbociclib and my cancer is currently stable. I take my pill every morning, and I get on with my life. I still cycle 3-4 times a week, which I could never have done had I been on conventional therapy.
Palbociclib allows me to live a good life with cancer and I want all cancer patients to have this hope and optimism for the future.
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said:
At the ICR, we believe precision cancer medicine should be driven by a test for every treatment ensuring that only patients who are likely to benefit from a drug are treated with it, and that patients who are likely to quickly relapse are closely monitored for signs of resistance.
Our researchers have developed a test which could ensure the exciting new drug palbociclib is used more effectively in the clinic, and that where necessary women can be moved promptly from it onto alternative treatments.
This kind of targeted, test-driven approach can reduce costs for the NHS, improve quality of life for patients and spare some people treatment that will not benefit them or which has stopped working.
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New test predicts chance of living more than a year on targeted breast cancer treatment - The Institute of Cancer Research
Recommendation and review posted by Bethany Smith
The First Study on ‘Abortion Reversal’ Landed Three Women in the ER – Free
For years, anti-choice advocates have promoted the unfounded idea that medication abortions can be reversed halfway through the procedure. If a patient changes their mind after taking the first abortifacient drugmifepristonethey can forego the second, misoprostol, and instead take several doses of progesterone to continue the pregnancy, according to the theory.
This claim hasnt just been promoted through anti-abortion activism and crisis pregnancy centers, but legislated, too: Currently, six statesArkansas, Idaho, Kentucky, South Dakota, Utah, and Virginiahave laws requiring providers to inform patients that they can request this abortion reversal treatment should they have misgivings about their decision to terminate, a phenomenon that is exceedingly rare.
While doctors have long contended that abortion reversal is nothing more than a myth intended to stigmatize the procedure, up until recently the treatment remained virtually untested. Now, new evidence shows that attempting abortion reversal can result in severe blood loss that could be life-threatening.
The findings are the result of the first-ever randomized, controlled clinical study on abortion reversal, conducted by researchers at the University of California, Davis, and published in the journal Obstetrics & Gynecology.
Originally, researchers set out to enroll 40 women in the study, who were already scheduled to have in-clinic abortions and consented to delaying the procedure for two weeks to test the abortion reversal method. These women would take a dose of mifepristone and then follow it up with either a placebo or progesterone. But researchers halted the study prematurely, after just 12 participants had been enrolled, when three women experienced vaginal hemorrhaging, or excessive bleeding, and needed to be taken to the ER via ambulance; one woman needed a blood transfusion. Two of them had received the placebo, and the other had received doses of progesterone. (On its own, mifepristone only stops the embryo from developing, while misoprostol is necessary to initiate uterine contractions to expel the pregnancy.)
Mitchell Creinin, the studys lead researcher a professor in the Obstetrics and Gynecology department at UC Davis, said that though his paper doesnt definitively debunk abortion reversal as ineffective, it shows that there are serious risks associated with not following through with the two-drug medication abortion regimen once its begun.
We dont have any evidence that disproves the possibility that abortion reversal exists, Creinin said. But I do have evidence that not completing the regimen as its designed is dangerous. The study concludes by recommending that states stop passing laws that require providers to discuss abortion reversal with patients: For now, the treatment remains experimental and "and should be offered only in institutional review boardapproved human clinical trials to ensure proper oversight."
Laws should not mandate counseling or provision of any treatment when we do not fully understand treatment efficacy (including best route of administration, dose, and duration) and safety, the paper reads.
A self-described "pro-life" doctor, George Delgado, originated the idea of abortion reversal in 2012, when he claimed hed discovered a method for chemically reversing the effects of mifepristone. The drug blocks the hormone progesterone, which is necessary for continuing a pregnancy. In a co-authored report at the time, Delgado said he had helped six pregnant women who had initiated a medication abortion carry their pregnancies to term by giving them injections of progesterone in the 24 hours after they took the mifepristone pills.
Ever since, anti-choice advocates have used Delgados claims to suggest that science supports the idea that abortions can be reversed. But Creinin and other experts say Delgados findings are based on bad science: Delgado didnt use a placebo as a control, nor did he randomize the study. What he produced was merely a series of case reports, Creinin said, which fail to prove a cause-and-effect relationship between post-mifepristone progesterone injections and continuing a pregnancy. (Delgado told VICE News in April that he plans on conducting another study that will include 900 women, though he still will not give any of the women a placebo as a control.)
There was zero evidence that such a thing as abortion reversal worked, Creinin said, but because Delgados claims had resulted in multiple state laws, he felt he had a duty to put them to the test.
The lack of evidence hasnt stopped people from passing these laws, so we wanted to take the question seriously, in a rigorous, controlled trial with Institutional Review Board approval, he continued. Patients deserve the truth.
Reproductive health advocates say the requirement that abortion providers in some states must inform patients of a reversal protocol that isn't supported by evidence is just one way anti-choice legislating infringes on the doctor-patient relationship. Five states mandate that providers tell patients that there is a link between abortion and breast cancer, a claim that has been widely discredited, and eight of the 23 states that require providers to inform patients of possible psychological responses to having an abortion emphasize negative outcomes, like depression and anxiety, which studies have shown are not caused by abortion.
[Abortion reversal] goes beyond laws that force providers to give information about unproven or disproven claims, like that abortion causes depression or breast cancer, said Daniel Grossman, the director of Advancing New Standards in Reproductive Health (ANSIRH), a program at the University of California, San Francisco. Laws requiring doctors to inform their patients of abortion reversal encourage patients to essentially participate in an unmonitored experiment. This latest study suggests there are actual safety concerns surrounding that.
Creinin said its important to emphasize that the dangers associated with attempting to reverse a medication abortion don't diminish the overwhelming safety and effectiveness of medication abortion itself, which has decades of research to back it up. In 2017, almost 40 percentor nearly 2 in 5abortions were done with pills.
The key is that medication abortion requires both medications, he said, which has been the official recommendation of organizations like the World Health Organization, the Food and Drug Administration, and the American College of Obstetricians and Gynecologists, for decades.
Medication abortion, performed through a combination of mifepristone and misoprostol, has provided a safe, effective option for induced abortion that has benefitted millions of women, said Chris Zahn, the vice president of practice activities at ACOG, which publishes the journal in which the study appears. Even with its limitations, [Creinins] study raises safety concerns about not completing the evidence-based regimen. Mifepristone is not intended to be used without follow-up misoprostol treatment.
Still, its unlikely that Creinins finding will change the minds of abortion opponents, who are likely to continue citing Delgados ongoing research, despite its flawed methodology. Several more states (including Georgia, Kansas, North Carolina, Ohio, and Wisconsin) have abortion reversal bills working their way through the legislature, and similar federal legislationcalled the Second Chance at Life Actwas introduced in the House in April.
But while Creinins study isnt definitive, since it had to conclude early, hes come to the end of his research. The first step of any series of studies is to establish safety, he saidif this had been, say, a clinical trial for a new birth control pill, the negative outcomes the participants experienced would preclude the possibility of continuing to research it.
You study something when theres a reason to study it, and we have no evidence that suggests abortion reversal is real, while we do have evidence that its potentially dangerous, Creinin said. So if I were developing a drug I would say, I have to stop.
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85-year-old man with Type 1 diabetes shatters expectations – WNDU-TV
There are more than a million people who have Type 1 diabetes, and they're expected to live at least 10 years less than Americans without it.
In fact, there are only 90 diabetics who have lived more than 70 years.
But one man crushed that goal 15 years ago and is telling others how they can do it too.
Eighty-five-year-old Don Ray can't remember a life without diabetes.
As a child, Don could not go to gym class. He couldn't play sports. He couldn't even play hide and seek.
"Because if you were to hide, and they can't find you and you have an insulin reaction or a hypoglycemia, you might really be in trouble because they will never find you," Don explains.
He was told he wouldn't live past his 30s. But eventually he got tired of hearing, "You can't, you can't, you can't."
"I would go to gym class when I started school in kindergarten and first grade, and I'd sit in the chair in gym class and I'd watch these kids, and I knew I could do this, cause I just knew I could do this," Don says.
Don and his dad started playing catch, and that turned into 20 years of playing football and 30 years of baseball.
And he did it because "he followed the rules," according to Betul Hatipoglu, MD, at the Cleveland Clinic.
What rules? First make sure your blood sugar is in check: between 80 and 130 milligrams. If it's too low, eat some carbs, but don't forget to check while working out.
"If they are going to exercise for an hour, they have to check it in 30 minutes again to make sure they are still in the safe zone," Hatipoglu says.
But don't take too much insulin before your meal or before your workout.
"So if you are going to exercise after lunch, for lunch you take less insulin so it is safer for you," Hatipoglu says.
And if you're working out after dinner, be careful as well. You don't want any overnight complications.
"If you take care of the disease, the disease will take care of you, and you can if you take care of yourself," Hatipoglu explains.
Nowadays, there are nearly 140,000 people diagnosed with diabetes each year in the U.S. alone. But in 30 years, an expected five million Americans will be diagnosed with Type 1 diabetes.
DIABETES TYPE 1: DON SHATTERS EXPECTATIONS! REPORT #2699
BACKGROUND: Glucose is a critical source of energy for your brain, muscles, and tissues. When you eat, your body breaks down carbohydrates into glucose and this triggers the pancreas to release a hormone called insulin. Insulin acts as a "key" that allows glucose to enter the cells from the blood. Your body can't function or perform properly if it doesn't produce enough insulin to effectively manage glucose. This is what produces the symptoms of diabetes. Uncontrolled diabetes can lead to serious complications by damaging blood vessels and organs. It also increases the risk of heart disease, stroke, kidney disease, nerve damage, and eye disease. Nutrition and exercise help manage diabetes, but it's also important to track blood glucose levels. Treatment may include taking insulin or other medications. (Source: https://www.healthline.com/health/diabetes/facts-statistics-infographic#1)
COPING WITH TYPE 1 DIABETES: People who have had type 1 diabetes for a long time may develop what's called "diabetes burnout." This can happen when you start to feel burdened by the disease. A good support system is essential to coping with type 1 diabetes. Spending time with friends and family or talking with someone you trust are ways to manage diabetes distress, which can include stress and anxiety. Taking good care of yourself can reduce diabetes stress and help you cope with the condition. Making sure to eat well, exercise, and learn how to monitor blood sugar levels are important. Getting enough sleep each night and taking time to relax and enjoy life are also very important. There are resources available to help you manage type 1 diabetes such as apps designed to count carbs, watch blood sugar levels, and track progress with diet and exercise. The more you know about your condition, the better prepared you'll be at taking care of yourself. Your doctor can also recommend books about type 1 diabetes. (Source: https://www.healthline.com/health/type-1-diabetes/living-with-type-1/how-you-can-cope#4)
NEW DISCOVERY FOR DIABETES: Matthias Hebrok, PhD, director of the UCSF diabetes center, and Gopika Nair, PhD, have discovered how to transform human stem cells into healthy, insulin producing beta cells. "We can now generate insulin-producing cells that look and act a lot like the pancreatic beta cells you and I have in our bodies. This is a critical step towards our goal of creating cells that could be transplanted into patients with diabetes," said Dr. Hebrok. For the longest time, scientists could only produce cells at an immature stage that were unable to respond to blood sugar levels and secrete insulin properly. The team discovered that mimicking the "islet" formation of cells in the pancreas helped the cells mature. These cells were then transplanted into mice and found that they were fully functional, producing insulin and responding to changes in blood sugar levels. Dr. Hebrok's team is already in collaboration with various colleagues to make these cells transplantable into patients. (Source: https://blog.cirm.ca.gov/2019/02/05/breakthrough-for-type-1-diabetes-scientist-discovers-how-to-grow-insulin-producing-cells/)
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Finding her way: Five years after gender-reassignment surgery Tamara Loyer helps other trans women – Vancouver Sun
Tamara Loyer proudly wears a bright red lanyard around her neck, from which dangles keys to the modest office where she oversees a unique Downtown Eastside drop-in program for trans women that she designed this year.
Shes come a long way in the past decade: from a despondent homeless woman trapped inside a body with male genitalia to someone who has undergone gender-confirming surgery and now has a home, goes to school and is employed.
Ive not been in an office setting since the mid-1980s, laughs Loyer during an interview at Atira Womens Resource Society, where she started the Beyond the Street drop-in for trans women in September.
Now 57, Loyer believes her internal war with her gender was at the root of her 30-year spiral into drug addiction, sex work and homelessness, and that the surgery she had in April 2014 gave her the confidence to start putting her life back together again.
After surgery, I thought I dont want to have to think about (gender) the way I did before. I can be part of the world. I can go and do things now without being self-conscious, she reflected. I walk around here and I dont have to be afraid that whats in my head and what people see arent the same.
She is happy with her outward appearance, but is inwardly still haunted by gender dysphoria a crippling unhappiness with ones biological gender.
After surgery, we all like to think that it will never bother me again. It still does. I think about it every day, she said.
Her dark thoughts are often triggered by still-lingering male gender traits, such as facial hair and a low voice. That bothers me still to this day. Im not as critical, as I was, at what I see in the mirror, (but) it doesnt go away 100 per cent.
Tamara Loyer in the Atira office.
The Vancouver Sun documented Loyers story in 2014: the challenges of applying for the surgery and organizing the logistics when you have a vulnerable lifestyle, no fixed address, a panhandlers income, and no family supports. At the time, B.C. funded sex-reassignment surgeries, but the only place in Canada that performed them was a private Montreal hospital, where Loyer was flown by a charity airline.
I had nobody with me and it was terrifying, she said. It was daunting. There is so much red tape to go through.
The number of B.C. patients that must endure that flight to Montreal is expected to decrease in the coming years. A new gender surgery clinic opened in Vancouver General Hospital in late September, where the Health Ministry anticipates full-scale gender-affirming surgeries will be performed, likely next year.
Two surgeons with specialized skills have been hired to work at the clinic, and since September have done repairs and revisions to previous surgeries, and performed parts of so-called lower surgeries but not yet the entire procedure, the Health Ministry said in a statement.
Until this year, patients in every province had to travel to Montreal for lower surgeries which include vaginoplasty for trans women and phalloplasty for trans men. In June, Ontario started to offer these complex surgeries at Womens College Hospital in Toronto, and B.C. plans to be the next province to do so.
The trans community has advocated over a number of years for improved access to care, including access to complex lower surgeries within B.C., Health Minister Adrian Dix said in November 2018, when he first indicated the services offered here would expand.
For those seeking lower surgery, people were required to travel to Montreal or to the U.S., resulting in additional medical risks associated with travelling long distance after surgery and in receiving followup care if there were complications.
Trans woman Morgane Oger, right, greets Health Minister Adrian Dix in November 2018 following his announcement that transgender people will soon have access to publicly funded gender-affirming lower surgeries.
The number of British Columbians travelling to Montreal has been on the rise, with about 100 patients annually in recent years. That number is expected to stay roughly the same in 2020, while the B.C. program fully ramps up, the Health Ministry said.
An estimated one per cent of the population identifies as trans, which includes a wide range of people for whom their gender is different from their assigned sex at birth. In B.C., the Health Ministry says, about 46,000 people identify as trans or gender diverse, but only a few will pursue medical or surgical services.
Offering the service closer to home will make it simpler to access and to allow friends to visit during recovery. That may encourage more trans people to consider surgery, especially those from marginalized communities like the Downtown Eastside, Loyer said.
And, she argued, it will benefit society in the long run to help more people feel in sync with their own bodies.
You are going to get a person who is going to be more productive. Somebody who might want to go to school, get a job. Somebody who might want to join their family again, she said.You dont have to live in despair, overwhelmed with what is described as an illness. You can be functional.
Trans people face discrimination and harassment, which often leads to poor mental health and a greater risk for suicide, says the Calgary-based Centre for Suicide Prevention.
Loyer speaks softly when she remembers trans friends who committed suicide, got killed, ran away, were never seen again, overdosed or became mental patients. She hopes these tragedies will be less frequent among her peers with the new local access to medical help.
Another set of surgeries many trans people pursue breast augmentation or chest construction were, until recently, offered in only Vancouver and Victoria. Now B.C. has 16 surgeons who do this work, and these procedures have been extended to Abbotsford, Burnaby, Port Moody, New Westminster, Kamloops, Kelowna and Prince George.
The demand for these upper surgeries in B.C. has quadrupled in just three years, with 49 performed in 2015-16 and 254 in 2018-19. The Health Ministry anticipates 300 breast or chest surgeries will be completed by the end of this fiscal year, in March 2020.
And B.C. has a waiting list for this procedure with more than 200 names.
In 2015, the Provincial Health Services Authority launched Trans Care B.C., which offers details about health care and support for trans people or their families. Its service directory lists dozens of drop-ins and information groups across the province, including in communities outside Metro Vancouver such as Prince Rupert, Fort St John and Cranbrook.
So much as changed since Loyer first arrived in Vancouver in 1984, at age 23, leaving behind a turbulent childhood on a Quebec military base. She came here to seek acceptance. She assumed the name Tamara, found work as a computer programmer and continued to pursue post-secondary education.
But she faced discrimination, numbed her pain with drugs, and eventually worked the streets to earn income. In 1989 she began inquiring about a sex-change operation, but had no stability to pursue surgery.
She was homeless, sick and dejected in 2011 when an outreach worker took her to the first place she felt at home: a shelter for woman, run by Atira. Despite the obvious challenges of sharing communal bathrooms with the female tenants of the modest shelter, Loyer began to heal and, through a new network of support, was able to get her surgery in March 2014.
The Healthy Ministry paid $20,000 for the procedure and $2,000 for her post-surgery care in Montreal. Doctors removed her male organs and created a vagina.
The Vancouver Suns first feature on Loyer was published one month after the operation, when she was still healing and had modest ambitions to live a more stable life.
Tamara Loyer panhandles on Cordova street in Vancouver in 2014.
Today, she says that it took her about six months to physically heal from the invasive surgery while she lived in Atira-supported housing in the heart of the Downtown Eastside. There were infections that required cleaning, extreme tenderness, and a daily routine of using dilators to ensure her new vagina wouldnt close up.
And there are post-operation steps that will be necessary indefinitely. Attached to her stomach is a patch that supplies very large doses of estrogen, a female hormone that her body considers a foreign substance and tries to reject.
But, overall, she is elated with the outcome of the surgery. I wake up in the morning and Im happy that I dont have to encounter a body that is what I had. That was one of the most horrible things in the shower and the washroom and getting dressed. And that is gone.
Loyer does not wear makeup, jewelry or fancy clothes, but rather prefers basic, gender-neutral garb.
I am happy with what I look like, she said. Its not the outside thats the problem. Its the inside that is giving me the problems.
In early 2019, Loyer was upgrading her high school credits at the South Hill Adult Education Centre in south Vancouver, but she was also still panhandling, which she found increasingly demeaning, to supplement her disability pension.
I didnt want to be there. I wanted to be in school.
Loyer appeared isolated, recalled Janice Abbott, the executive director of Atira, so she suggested Loyer open a drop-in for trans women. Atira offered space to hold the meetings, a small budget for food and communication, and the encouragement for Loyer to independently create a program that was needed in the Downtown Eastside.
The trans community is complex, its not homogeneous in any shape or form. So I think that more opportunities for safe space in ways that trans women identify their own communities, I think that there needs to be more (of) that, said Abbott, adding that Loyers drop-in is a low-key environment where people can make friends and share challenges.
I think everyone in the Downtown Eastside needs an informal place, where you dont have to come in and fill out a form that says I need social services. Its a place to get a snack and have a cup of coffee and hang out for a couple of hours. And I think thats part of what makes it beautiful.
Janice Abbott, CEO of the Atira Womens Resource Society, looks over a room in a supported-housing building in the Downtown Eastside.
Loyers program, Beyond the Street, is among the first peer-led drop-ins for trans women in Vancouver. It has been holding two-hour sessions every Sunday afternoon since September.
It focuses on offering people help in three main areas: housing questions, such as dealing with transphobia while looking for an apartment or getting evicted; legal matters, such as how to change your name or marriage breakup help; and counselling issues, such as being trapped in a lifestyle that isnt true to your identity. The program also offers fun activities like Thanksgiving dinner and movies.
Sometimes trans women get stalled. Something happens and you stop. You cant get anywhere, whether its housing or medical. The idea is to keep them going, said Loyer.
The three-month-old drop-in has 12 regular attendees, but Loyer also helps women in other communities by phone or email.
She hopes the program can offer marginalized trans woman better options than they often faced in the past: You end up on the street corner, or you end up in the alleys, or you break down and cry, or you suicide.
We try to keep people from saying, Oh well, this is what I get. Which is easy to think when you dont have anybody saying anything different, Loyer said.
Among Atiras many social housing buildings, which accommodate more than 1,500 women and children every year in the Lower Mainland, up to 20 per cent of the adult female tenants identify as trans, depending on the building type and location, Abbott said.
Many trans women also use Atiras SisterSpace, which is described as the first women-only overdose prevention site in Canada. Evaluation reports on Atiras website quote trans women who say the safe space offers empathetic workers and an escape from transphobia.
Trans issues have increasingly been in the news. In a high-profile court case, a local father who opposes his transgender childs pursuit of testosterone therapy fought lower-court decisions all the way to the B.C. Court of Appeal.
And the provincial government recently introduced SOGI, or sexual orientation and gender identity learning resources for elementary and high schools, which created controversy.
For Loyer, trans issues are not new. Theyve been bottled up inside of her for five decades. She hopes, though, that more attention will lead to increased acceptance.
Since her surgery in 2014, she said, her health has improved drastically. The hepatitis C she contracted in 1989 from intravenous drug use is now not detectable in her blood. She is drug-free and quit her 30-year smoking habit. She can walk without a cane, which she had used since her leg was broken in a nasty 2011 assault. Her sight has improved after a hole in her cornea, likely from a beating, was repaired. And she now weighs 165 pounds, up from the 109 she weighed when she arrived on Atiras doorstep nearly nine years ago.
She no longer lives in supported housing, and has moved to a mixed-income Atira building where many of her neighbours have jobs and go to school. While B.C. Housing subsidizes her rent, Loyer must pay for utilities, internet, and other living expenses.
Perhaps she is most excited about the high school science and math courses she is taking to boost her marks so she can one day apply to the University of British Columbia for a combined degree in astronomy and physics. A downtown investment firm, who read about Loyer in 2014 in The Vancouver Sun, has told her it will pay for her tuition if she gets accepted to UBC.
But with that excitement also comes the fear of failure.
I need to find a place to apply myself. But the science part I was really nervous about. I didnt want to think that I could do something and find out that I made a total mess of it and lose confidence, she said.
Loyer will need confidence to complete her academic goals. She has displayed confidence already, though, in the pursuit of her gender goals. And she has a favourite saying that has, in the past, given her courage and determination: Its a song title from the movie The Rocky Horror Picture Show, which she saw in Toronto in 1978 after she ran away from home, at age 16, so she could start living as a woman.
Dont Dream it. Be it.
Twitter: @loriculbert
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IFN-: The T cell’s license to kill stem cells in the inflamed intestine – Science
Abstract
IFN- produced by T cells directly induces intestinal stem cell death upon inflammation-induced intestinal injury (see the related Research Article by Takashima et al.).
Intestinal regeneration upon tissue damage is fueled by intestinal stem cells (ISCs) residing in the crypt bottom of the epithelium and marked by the gene Lgr5 (1, 2). There is growing evidence that tissue repair is at least partially mediated by a regenerative inflammatory response (3, 4). How inflammation-induced intestinal injury influences ISCs and their microenvironment (stem cell niche) remains poorly understood. In this issue of Science Immunology, Takashima et al. (5) explore the changes in the ISC niche in vivo upon T cellmediated injury as a model of graft-versus-host disease (GVHD) and in vitro using organoid T cell cocultures. Although earlier studies already implicated interferon- (IFN-) as a negative regulator of intestinal epithelial homeostasis (68), Takashima et al. now demonstrate that IFN- directly acts on ISCs by triggering apoptosis.
In an allogeneic bone marrow transplant (BMT) model, Takashima and colleagues found that ISC numbers per intestinal crypt were markedly reduced in mice receiving bone marrow alone or bone marrow and T cells when compared with normal control mice. While the ISCs in the mice receiving only bone marrow recovered 7 days later, the ISC numbers remained reduced in those mice also transplanted with donor T cells. Of note, Paneth cell numbers were also reduced after ISC depletion. The numbers of organoids established from the intestines of mice 10 days after BMT recovered back to that of control mice, whereas the organoid forming capacity from crypts of mice after combined transplantation of bone marrow and T cells remained significantly lower. Similar in vivo and in vitro results were obtained when autoreactive T cells were transplanted, pointing to a common feature of T cellmediated intestinal injury.
As seen by three-dimensional confocal microscopy, intraepithelial T cells (CD3+ IELs) preferentially localized to the villus region, whereas lamina propriaassociated T cells (CD3+ LPLs) were equally distributed along the crypt-villus axis of control mice (Fig. 1A). Conversely, mice receiving bone marrow and allogeneic T cells showed a progressive increase in the density of both CD3+ LPLs and CD3+ IELs in the crypt region.
To identify signaling molecules that cause the loss of ISCs in this model, Takashima and colleagues performed several elegant murine and human epithelial organoid coculture experiments. Murine nave allogeneic T cells did not impair murine intestinal organoid numbers, whereas alloreactive T cells effectively reduced organoid numbers. Likewise, human allogeneic cytotoxic T cells robustly inhibited human intestinal organoid forming efficiency. Even bead-activated autologous T cells suppressed human intestinal organoid growth. The authors then proceeded to screen for potential pathways mediating cytotoxicity. Organoids cocultured with T cells in the presence of antiIFN- neutralizing antibodies showed normal growth. Although IFN- receptor (IFN-R)depleted T cells were still able to affect organoid viability, IFN-Rdepleted organoids were resistant to T cellmediated killing. Organoid toxicity by IFN- was also observed in the absence of T cells. Live imaging confirmed the progressive ISC depletion upon organoid exposure to IFN-. Treatment of organoids with the immunosuppressive JAK1/2 inhibitor ruxolitinib robustly preserved numbers of both organoids and ISCs in the presence of IFN-, irrespective of whether the organoids were cultured alone or together with T cells. The authors additionally demonstrated that JAK1-depleted organoids are resistant to IFN- treatment. Further downstream, ruxolitinib prevented STAT1 phosphorylation by IFN- in intestinal crypts, and, in line, STAT1-depleted organoids were resistant to growth suppression in response to IFN- treatment.
IFN-treated organoids showed reduced expression of ISC marker genes. ISCs underwent apoptosis in vitro in a direct response to IFN-. Next, the authors confirmed in vivo that ISC numbers did not change upon transplanting allogeneic bone marrow and T cells when treating mice with IFN- neutralizing antibodies. Likewise, ruxolitinib treatment protected ISCs from T cellmediated killing in vivo. Donor T cells, particularly T helper 1 cells, were activated and IFN-+. Transplanting IFN-depleted allogeneic T cells robustly reduced the ISC loss and allowed epithelial cell proliferation to increase.
Takashima and colleagues lastly investigated whether IFN- directly induces ISC apoptosis. Using tissue-specific depletion of IFN-R1, the authors found that epithelial loss of the receptor protects from the immune-mediated GVHD phenotype. IFN-R1 is expressed by both ISCs and Paneth cells, the epithelial component of the ISC niche (9). However, Paneth celldeficient organoids remained sensitive to both IFN- and allogeneic T cellmediated cytotoxicity. Likewise, T cells were able to reduce the number of organoids containing IFN-R1deficient Paneth cells, whereas organoids containing IFN-R1deficient ISC were protected from cytotoxicity. The authors demonstrated in further experiments that IFN- directly induces ISC apoptosis independent of Paneth cells (Fig. 1, B and C).
The study by Takashima et al. extends our knowledge on signaling between ISCs and immune cells, identifying ISCs as direct targets of IFN- secreted by T cells in immune-mediated intestinal damage (as caused by GVHD). In the 2015 study by Lindemans et al., this group already identified that interleukin-22 (IL-22) secreted by group 3 innate lymphoid cells (ILC3s) directly stimulates ISCs to proliferate and regenerate the intestinal epithelium upon inflammation-induced intestinal injury (4). Modulating the effects of T cellderived IFN- on ISC, for instance, by suppressing JAK/STAT signaling via ruxolitinib treatment, may provide a new therapeutic avenue to reducing GVHD-induced damage of the intestinal epithelium (10).
(A) ISCs maintain adult homeostasis of the intestinal epithelium. T lymphocytes patrol the intestine. (B) Takashima et al. show that in GVHD as modeled by BMT and aberrant activation of T lymphocytes, T cellderived IFN- directly acts on ISCs and induces apoptosis via JAK/STAT signaling. (C) Disease progression results in marked intestinal damage due to loss of ISCs and their niche.
Acknowledgments: Funding: K.K. is a long-term fellow of the Human Frontier Science Program Organization (LT771/2015). Competing interests: H.C. and K.K. are named inventors on patents or patents pending on Lgr5 stem cellbased organoid technology.
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3-year-old needs bone marrow transplant to survive, says UAE-based father – Gulf News
mohammad hassan 3 years and two months Image Credit:
Dubai: The father of a three-year-old boy in Dubai, whose only hope for survival is a bone marrow transplant, is desperately appealing for help.
Hafeez Khan, father of Mohammad Hassan, said the boy who is suffering from acute myeloid leukaemia (AML), needs Rs4.8 million (Pakistani) or Dh114,000 for his treatment, which includes one-two cycles of chemotherapy and a bone marrow transplant, in Pakistan.
Hassan, who has not been able to attend school as he has been in and out of hospitals in Dubai and Pakistan, was first diagnosed with AML when he was only a year and a half. He remained under treatment at a Dubai hospital for nearly a year until October 2018.
After a brief remission, he developed high fever and body pain on October 17 this year. When he did not respond to any regular medications, we took him to a Dubai hospital where his AML relapse was confirmed, said the father.
He said investigations revealed that Hassan had a soft tissue mass in his sinus which was diagnosed as a chloroma, a solid collection of leukemic cells occurring outside the bone marrow.
Khan, who works as a site engineer for a Dubai-based company, said, Hassan is my first born and I will do everything I can to save him. I appeal for any support that I can get towards this effort.
He said the child was earlier scheduled to have a bone marrow transplant in Turkey but due to the prohibitive costs, they were nowconsidering Pakistan. Still, the estimates we have been given are beyond our reach,Khan said, adding that he was praying for a miracle to save his son.
AML is one of the commonest types of leukaemia or blood cancer in children. In AML, the body makes many immature white blood cells. These cells, called myeloid blasts, cant mature into normal white blood cells. Although AML is a serious disease, it can be cured with high intensity chemotherapy and a bone marrow / stem cell transplant at an early stage.
mohammad hassan 3 years and two months Image Credit:
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Jasper Therapeutics launches out of Stanford with new approach to stem cell treatment – Endpoints News
The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didnt take. Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.
She has normal T cells now, Judith Shizuru, the Stanford scientist who pioneered the antibody, told Endpoints News. Shes in school.
Its the kind of medical story to launch a biotech around, and thats what Shizuruis doing. Today, her company Jasper Therapeutics is emerging out of stealth-mode with $35 million in Series A funding led by Abingworth and Qiming, a molecule from Amgen, and a Phase I trial set for its first readout on Monday at ASH.
Jasper is broadly aimed at making stem cell transplants safer, more accessible and more effective by using antibodies as conditioning agents. Theseagents clear out bone marrow to make room for the new stem cells to graft onto the body.
Their Phase I uses a naked antibody called JSP191 to help patients with severe combined autoimmune deficiency receive stem cell transplants the only possible cure for the life-threatening disease but such transplants are used in a wide variety of conditions and Jasper has broader aims. Those include other autoimmune diseases, acute myeloid leukemia and cell-directed gene therapy.
Theres a significant amount of progress being made in gene therapy, interim CEO William Lis told Endpoints, but no progress being made in a conditioning agent that will help graft gene therapy.
Shizuru path to the new antibody was long and fortuitous. In 1987, Arl Arzst, the legendary ad executive and president of Proctor and Gamble international flew in on a recruiting trip for Stanford business students. There he visited Shizuru, a young biologyPhD candidate, because he knew her roommate. Arzsts daughter had diabetes and as Shizuru explained the work she was doing on pancreatic islet cell transplants, he told her to come to Europe.
Shizuru had never been to Europe, but there Arszt introduced her to Ken Farber and the other founders of the Juvenile Diabetes Foundation (now the JDRF). The founders struck a years-long correspondence and encouraged Shizuru to go to medical school, where she decided that if scientists were ever going to develop transplants that didnt trigger an immune response, it would be through stem cell work. She continued her work at the Irv Weissman Stanford regenerative lab, where eventually a graduate student made a discovery that piqued her interest.
To put new stem cells in, you have to get the old stem cells out. Thats not always easy. The cells sit inthese pockets in the bone marrow, and theyre pretty comfortable there. Doctors have to force them out, often using chemotherapy or radiation, which damage DNA and cause severe side effects. The costs sometimes outweigh the benefits.
There are diseases were not treating because its too dangerous, Shizuru said. And the kids were treating, theyre so, so fragile.
The grad student had shown in mice that antibodies could be used to deplete the stem cells and potentially eliminate the need for chemotherapy or radiation. Shizuru and her team began looking to see if anyone had developed a human version of the antibody, CD117. It turned out Amgen had already developed a version of this antibody for a different use. It also turned out she had a former postdoc and a former advisor who worked there. They began a collaboration.
We set out to cross the valley of death, Shizuru said, using an industry slang term for the jump from animal models to human uses.
After making a variety of tweaks to the treatment, they published a paper inScience Translational Medicine in 2016showing the antibodies created a 10,000 fold reduction in the number of stem cells in mice.
The same year, they began a clinical trial on 90 SCID patients. These patients had received stem cell transplants when they were very young but hadnt been given chemo or radiation for fear the side effects would be too severe. The original transplants boosted their numberof immune cells, but without chemo or radiation, the stem cells dont graft into those pockets and the body wont continue producing T cells. Without those, they are extraordinarily prone to infection. Many pass away before age 2.
The hope is that the antibodies allowed the stem cells to graft, and the preliminary answer to that question will be out on Monday. For the first girl in the trial, life has improved but questions about how long her body will make immune cells remain. Still, for that girl and others, Shizuru is confident.
We see there is stem cell engraftment, Shurizi said. They are actually making new T cells.
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Howard University athlete makes the call to donate stem cells – WTOP
This fall, 21-year-old Jurnee Farrell, a Howard University senior and a member of the universitys volleyball team donated stem cells to a complete stranger.
This fall, 21-year-old Jurnee Farrell, a Howard University senior and a member of the universitys volleyball team, was set to play in the Mid-Eastern Athletic Conference Tournament.
But instead, she was sidelined by a decision she made herself.
Two years ago, she signed up with Be the Match, a nonprofit that registers potential bone marrow and stem cell donors. When she got the call that she was a match for a 57-year-old woman with a form of leukemia, she was surprised.
At first I was like, This isnt real, Farrell recalled, but then said her decision was clear. She would follow through on the commitment she made two years ago when she signed up.
That meant undergoing a series of shots five days before the outpatient procedure, and then undergoing apheresis, a process in which the donor has blood removed through a needle in one arm, blood-forming cells are collected, and then the blood is returned through a needle in the other arm. The session can take up to eight hours.
Farrell said that the actual donation wasnt bad, but that the shots given in a series five days prior proved a little uncomfortable.
Nevertheless, she urges potential donors to sign up.
Its really not that bad, and the person whose life youre saving is probably going through so much more than you are, she said.
And while Farrell missed the tournament last month, shes back on the court already. We are going to the NCAA tournament this weekend, actually, and we play Pitt on Friday, she said. I just started practicing last week!
Farrells decision to register as a donor is one for which the staff at Be the Match is especially grateful.
Lauren Mueller, a public relations specialist with Be the Match, explained that for Caucasian patients waiting for a bone marrow or stem cell donation, the odds of finding a match are roughly 70%. For African-American patients, the odds are much lower, at 23%.
As a result, we are always looking to increase our diversity on the registry, said Mueller, who encourages people to consider registering.
It starts with a cheek swab, and Mueller said its not uncommon for years to go by before a potential donor hears that they might be a match, just as it was in Farrells case.
Your selfless action can help save a life, Mueller said.
Farrell said that shes hopeful her donation will prove successful, and that she would love to meet the recipient one day.
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Sickle Cell Anemia Patient Becomes First Person in the US to Have Her Genes Edited With CRISPR – Interesting Engineering
Last week, a woman namedVictoria Gray became the first person in the U.S. to have her cells edited with CRISPR. The41-year-old patient was sufferingfromsickle cell anemia.
RELATED:FIRST HUMAN TRIAL USING CRISPR GENE-EDITING IN US BEGINS
The condition, caused by a genetic mutation that messes with the shape of red blood cells, causes havoc on patients, and to make things even worse, the options for treatment are very limited and ineffective. The only current treatment for sickle cell anemia patients is a donor transplant that works for just 10% of patients, but all that is about to change.
It was clear that analternative, much more effectivesolutionwas desperately needed. After much consideration, doctors believed that editing cells extracted from a patient's own bone marrow could restore effective red blood cell creation, and this is exactly the operation they attempted on Gray.
The doctors used CRISPR to tweak Gray's bone marrow DNA to turn on a specific protein that would allow proper red blood cell generation. The operation makes Gray the first person in the U.S. to undergo a CRISPR editing procedure and the second globally.
The treatment comes from observations made back in the 1940s.In 1941 a pediatrician named Jane Watson noticed that babies with sickle cell didnt have symptoms until 6 months to 1 year of age, Vivien Sheehan, a hematologist at Baylor University told Popular Science.
The pediatrician also discovered that these infants produced fetal hemoglobin for much longer periods than healthy babies.Following Watson's observations, the research since then has indicated that increasing fetal hemoglobin could provide an effective treatment for the disease.
Now, CRISPR may just make that treatment viable. But before we get too excited, it should be noted that the strategy comes with several risks.
In order for the edited cells to be inserted back into the patients bone marrow, other stem cells need to be deactivated. Otherwise, there is the chance the unedited stem cells may continue to produce sickled red blood cells very fast, outpacing the edited cells' production of healthy cells.
Now researchers say they need to follow Gray's progress for at least 15 years to rule out any other potential dangers of the procedure. Still, for those 90% suffering with sickle cell anemia that don't respond well to current treatment, the procedure, if successful, would offer the much-needed lifeline they've been hoping for.
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Sickle Cell Anemia Patient Becomes First Person in the US to Have Her Genes Edited With CRISPR - Interesting Engineering
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Howard University Student Gives a Stranger the Greatest Gift for the Holidays: Life – Howard Newsroom
WASHINGTON WhenHoward University student athlete Jurnee Farrellsigned up for the Be The Match registry during a Get In The Game campus drive, she didnt know if she would ever be called upon. However, when her phone rang two years later and she discovered she was a match for a 57-year-old woman suffering from acute lymphoblastic leukemia, she did not hesitate to participate.
The football team was hosting a Be The Match booth after Coach London had donated bone marrow to his daughter, recalls Farrell. I filled out a little form and turned it in. When I got the call a few months ago, they asked if I was still interested in donating. I didnt hesitate to say yes because this is somebodys life and there was no way I could say no to that.
Farrell is a senior criminology major from Denver, Colorado, and a member of the Howard University MEAC Championship Volleyball team. Wearing jersey No. 5 as a defensive specialist, Farrell is known for her bubbly personality off the court and her intensity on the court. At senior night, the day before her donation, the entire team rallied behind her in support of her decision. Unfortunately, the timing of the donation process meant that Farrell was not able to participate in this years MEAC playoffs with her teammates, who brought home their fifth MEAC championship on Nov. 24.
Of course, we were sad to miss out on having Jurnee play in the playoffs, but this is such a worthy cause and we were happy to support her all the way, saysHead Volleyball Coach Shaun Kupferberg.What she is doing speaks directly to Howard Universitys mission of truth and service, that each student comes here not only to learn, but to make a difference in the global community. Im extremely proud of her decision.
Thanks to several medical advances, the process to donate stem cells has drastically changed over the years. In addition to bone marrow donations, doctors can also use a stem cell procedure called Peripheral Blood Stem Cell (PBSC) donation through a short 4-hour out-patient procedure where blood is circulated from one arm, into a machine and then back into the donor.
Beth Carrion, account manager for Registry Growth and Development, says individuals like Farrell help to demystify the giving process and raise awareness of the need for a more diverse donor registry. The chances of finding a match for a stem cell transplant is dependent on a persons genetic markers. Outside of a family member, finding a donor within in ones ethnicity is the next viable option. According to Be The Match, each year approximately 14,000 patients are waiting for a transplant from someone outside of their family. The current odds to match a patient with a donor in one out of 430.
Be the Match is truly thankful for our partnership with Howard University because it plays a vital role in helping the African American community have a higher rate of finding a match, says Carrion. A white person in the registry has a 78 percent chance of finding a match. For Hispanics, its 46 percent, but for African Americans, its only a 23 percent chance. We look forward to hosting more events with Howard this spring.
One week after her procedure, Farrell is back at volleyball practice with her fellow teammates, preparing for the Tournament. As she looks to finish out her senior year, she says shes also hopeful that shell get to meet the woman she helped one day.
After the donation, I can have anonymous communication, but I cannot tell my identity. After a year, they will deem the transplant successful and then we can communicate, says Farrell. I for sure want to meet her.
To join the Howard University registry, text Howard to 61474, follow the prompts and a kit will be mailed to you. You may also register online atjoin.bethematch.org/howard.
# # #
Media Contact: Alonda Thomas,Alonda.Thomas@Howard.edu
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Autolus Therapeutics Announces New Data Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline in Blood Cancers – GlobeNewswire
AUTO1 shows 87% MRD negative complete response in adult patients with r/r ALL, with no severe cytokine release syndrome
Data presented at 61st American Society of Hematology Annual Meeting form basis for advancement of AUTO1 into pivotal clinical trial in adult ALL
Investor call to be held December 9 at 8:30 am ET / 1:30 pm GMT to review data
LONDON, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL) announced today new data highlighting progress on its next-generation programmed T cell therapies to treat patients with acute lymphoblastic leukemia (ALL) and adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The data were presented in oral presentations at the 61stAmerican Society of Hematology(ASH) Annual Meeting and Exposition inOrlando, FL. Additional data on pediatric patients with ALL will be presented on December 8.
The data on AUTO1 presented at this years ASH meeting demonstrate the favorable safety profile and high level of clinical activity of AUTO1 in both adults and pediatric patients with ALL, and we look forward to initiation of the pivotal program in adult ALL in the first half of 2020, said Dr. Christian Itin, chairman and chief executive officer of Autolus.
Acute Lymphoblastic Leukemia Data Presented
Title: AUTO1 A novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Abstract # 226)
Updated results for ALLCAR19, the Phase 1 trial evaluating AUTO1 in adults with recurrent/refractory ALL, were presented by Dr. Claire Roddie MB, PhD, FRCPath, honorary senior lecturer,Cancer Institute, University College London (UCL), in an oral presentation. The trial is designed to assess the primary endpoints of safety ( Grade 3 toxicity) and feasibility of product generation, as well as other secondary endpoints, including efficacy. The trial enrolled patients with a high tumor burden (44% had 50% BM blasts), who were considered high-risk for experiencing cytokine release syndrome (CRS). Product was manufactured for 19 patients; product for 13 of those patients was manufactured using a semi-automated closed process, which will be used for commercial supply.
As of the data cut-off date of November 25, 16 patients had received at least one dose of AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 CRS, and 3 of 16 patients (19%), who had high leukemia burden, experiencing Grade 3 neurotoxicity that resolved swiftly with steroids.
Of 15 patients evaluable for efficacy, 13 (87%) achieved MRD negative CR at 1 month and all patients had ongoing CAR T cell persistence at last follow up. CD19-negative relapse occurred in 22% (2 of 15) patients. In the patients dosed with AUTO1 manufactured in the closed process, 9 of 9 (100%) achieved MRD negative CR at 1 month and 6 months event free survival, and overall survival in this cohort was 100%.
Adult ALL patients, who face a median survival of less than one year after their ALL recurs or relapses, have a significant need for a CAR T cell therapy that is highly active, safe and is a standalone therapy not requiring a stem cell transplant, said Dr. Hagop M. Kantarjian, Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center.
The novel CD 19 CAR-T therapy, AUTO1, is potentially transformative as a standalone curative option for patients with r/r ALL, especially in adults, given its favorable safety profile, said Dr. Max Topp associate professor of Internal Medicine, Hematology and Oncology at the University of Wuerzburg.
Title: Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Abstract # 225)
Dr. Sara Ghorashian, honorary senior lecturer, Great Ormond Street Institute of Child Health, University College London, presented updated data from the phase 1 CARPALL study of AUTO1 in pediatric ALL patients with low bone marrow tumor burden. The trial is intended to assess the primary endpoints of safety and proportion of patients in molecular complete remission at 1 month. The study recruited a total of 25 patients and stratified them into 2 cohorts. Fourteen patients were treated in cohort 1, which utilized a manual manufacturing process; product was unable to be generated in 3 patients. Median follow-up was 27 months in cohort 1. Seven patients were treated in cohort 2, which utilized the semi-automated closed manufacturing process, which will be used for commercial supply. The aim of cohort 2 was to demonstrate feasibility of manufacture at scale. Product was generated for 100% of patients. Median follow-up was 7 months in cohort 2.
AUTO1 was well-tolerated overall, with no patients experiencing Grade 3 CRS and 1 of 21 (5%) experiencing Grade 4 neurotoxicity, which was considered unrelated to CAR T therapy.
Nineteen of 21 treated patients (90%) achieved molecular complete remission at 1 month post infusion. Consistent with pre-clinical data, CAR T cell expansion was excellent and detectable by flow in a number of patients up to 36 months. Persistence was noted in 15 of 21 patients at last follow-up, up to 36 months. In cohort 2, 100% of patients achieved molecular complete remission at 1 month post infusion.
In the 14 patients in cohort 1, the overall survival at 6 months was 86% and at 12 months was 71%; event free survival (EFS) at 6 months was 71% and at 12 months was 54%. The patients in cohort 2 are not yet evaluable for these parameters. Overall, nine patients relapsed; 5 of 8 evaluable relapses were due to loss of CD19 antigen on the tumor cells.
Title: Clonal dynamics of early responder and long-term surviving CAR-T cells in humans (Abstract # 52)
Dr. Luca Biasco, senior research associate at University College London, presented a detailed analysis of CAR T products, and insertion site analysis from the CARPALL phase 1 patients. This analysis revealed highly polyclonal engraftment, even at very late time-points. Dr. Biasco hypothesized that the propensity for high level polyclonal long-term engraftment was due to favorable phenotype of the CAR T product and the binding kinetic of the receptor.
Diffuse Large B-cell Lymphoma Data Presented
Title: Phase 1/2 study of AUTO3, the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of cohort 1 and 2 of the ALEXANDER study (Abstract # 246)
Dr. Kirit Ardeshna, consultant hematologist, Department of Hematology, University College London Hospital NHS Foundation Trust, presented updated data from the ALEXANDER Phase 1/2 study of AUTO3, the first bicistronic CAR T targeting CD19 and CD22 followed by an anti-PD1, in diffuse large B cell lymphoma (DLBCL). 16 patients were treated, and fourteen patients were evaluable at one month. AUTO3 was well-tolerated, with no patients experiencing Grade 3 CRS with primary treatment, and 1 of 14 experiencing Grade 3 neurotoxicity that resolved swiftly with steroids. Five of 14 had a complete response, with 4 of 5 complete responses ongoing, the longest at 18 months.
DLBCL is an aggressive and rapidly progressing cancer, and early response is critical to ensuring positive outcomes for these patients. These early data show the promise of AUTO3 in DLBCL, and we expect to advance AUTO3 to a decision point in relapsed/refractory DLBCL by the middle of next year, said Dr. Christian Itin, chairman and chief executive officer of Autolus. In addition, we look forward to presenting the data from the AMELIA trial of AUTO3 in pediatric ALL during poster sessions on Sunday, December 8, 6:00 8:00 PM ET.
Investor call to review data on Monday, December 9
Autolus management will host an investor conference call on Monday, December 9, at 8:30 a.m. EDT/ 1:30pm GMT, to review the data presented at ASH.
To listen to the webcast and view the accompanying slide presentation, please go to:https://www.autolus.com/investor-relations/news-and-events/events.
The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9796038. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9796038.
About AUTO1
AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells' abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights fromUCL Business plc(UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL.
About AUTO3
AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.
AboutAutolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, as well as statements regarding the anticipated development of Autolus product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
Investor and media contact: Silvia TaylorVice President, Corporate Affairs and Communications Autolus+1-240-801-3850s.taylor@autolus.com
UK:Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com
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Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas – Business Wire
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data on two investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in people with relapsed or refractory (R/R) B-cell non-Hodgkins lymphoma (NHL). Results from the Phase I/Ib GO29781 study of mosunetuzumab, including data from people previously treated with chimeric antigen receptor (CAR) T-cell therapy, will be presented at the 61st American Society of Hematology (ASH) 2019 Annual Meeting during the Plenary Scientific Session. The Plenary Scientific Session highlights the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Additionally, results from the Phase I/Ib NP30179 study evaluating CD20-TCB as a combination therapy with Gazyva (obinutuzumab) for people with R/R NHL, will be presented.
Despite recent treatment advancements, slow-growing and aggressive non-Hodgkins lymphomas present increasingly difficult management challenges with each subsequent relapse, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Were encouraged by these early results, which suggest that our novel bispecific cancer immunotherapies may help people with relapsed or treatment-refractory disease who need more options.
The GO29781 study evaluated mosunetuzumab in patients with R/R NHL, including patients who have relapsed following, or are resistant to, CAR T-cell therapy a patient population with limited treatment options. Results from this dose-escalation study showed encouraging efficacy with an objective response rate (ORR) of 62.7 percent (n=42/67) in slow-growing NHL and 37.1 percent (n=46/124) in aggressive NHL. Additionally, data demonstrated a complete response (CR) rate of 43.3 percent (n=29/67) in slow-growing NHL and 19.4 percent (n=24/124) in aggressive NHL. CRs showed durability, with 82.8 percent (n=24/29) of patients with slow-growing NHL remaining in remission up to 26 months off initial treatment and 70.8 percent (n=17/24) of patients with aggressive NHL, remaining in remission up to 16 months off initial treatment. Of the participants who received prior CAR T-cell therapy, the ORR was 38.9 percent (n=7/18), and 22.2 percent (n=4/18) achieved a CR. Adverse reactions included cytokine release syndrome (CRS) in 28.9 percent of patients with 20.0 percent at Grade 1 and 1.1 percent at Grade 3. Grade 3 neurological adverse events occurred in 3.7 percent of patients.
Results from the Phase I/Ib dose-escalation NP30179 study, evaluating CD20-TCB at doses ranging from 0.6 mg to 16 mg plus Gazyva in people with R/R B-cell NHL, showed an ORR of 54 percent (n=15/28) and a CR rate of 46 percent (n=13/28). This included an ORR and CR of 66.7 percent (n=4/6) in people with follicular lymphoma and an ORR of 50.0 percent (n=11/22) and a CR of 40.9 percent (n=9/22) in aggressive NHL. The most frequently observed adverse event across all treatment doses was CRS, occurring in 67.9 percent of patients (n=19/28), with the majority of events being low grade (Grade 1-2).
Both mosunetuzumab and CD20-TCB continue to be evaluated in a robust clinical development program, investigating the treatments as monotherapies and in combination with other therapies, in people with slow-growing and aggressive forms of NHL.
About Genentechs Investigational Bispecifics
Genentech is currently developing two T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patients existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab and CD20-TCB differ in their structures, and both are being developed by Genentech as part of our ongoing strategy to explore multiple bispecific formats, to identify those that maximize potential clinical benefits for patients. The clinical development programs for mosunetuzumab and CD20-TCB include ongoing investigations of these molecules as monotherapies and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkins lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma.
About the GO29781 study
The GO29781 study [NCT02500407] is a Phase I/Ib, multicenter, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.
About the NP30179 study
The NP30179 study [NCT03075696] is a Phase I/Ib, multicenter, open-label, dose-escalation study, evaluating the efficacy, safety, tolerability and pharmacokinetics of CD20-TCB. In this study, CD20-TCB is assessed as a single agent and in combination with Gazyva, following pre-treatment with a one-time, fixed dose of Gazyva, in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include overall response rate, complete response rate per Lugano 2014 criteria, maximum tolerated dose, and tolerability.
About Non-Hodgkins Lymphoma
There are two main types of lymphoma: Hodgkins lymphoma and non-Hodgkins lymphoma (NHL). NHL has two subsets, aggressive and indolent (slow-growing).
NHL represents approximately 85 percent of all lymphomas diagnosed. According to the American Cancer Society, it is expected that nearly 74,000 people will be diagnosed with NHL in the United States in 2019, and nearly 20,000 will die from the disease.
Most cases of NHL start in B-lymphocytes, cells that are part of the bodys immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.
Gazyva Indications
Gazyva (obinutuzumab) is a prescription medicine used:
Important Safety Information
The most important safety information patients should know about Gazyva
Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life threatening, including:
Who should not receive Gazyva:
Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including:
The most common side effects of Gazyva in CLL were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.
The safety of Gazyva was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81 percent), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which Gazyva is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of Gazyva were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection.
A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of Gazyva as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86 percent) or marginal zone lymphoma (14 percent).The most common side effects of Gazyva were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea.
Before receiving Gazyva, patients should talk to their doctor about:
Patients should tell their doctor about any side effects.
These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.
Gazyva is available by prescription only.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, were investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas - Business Wire
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FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell…
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Todays approval offers another opportunity to help prolong the lives of people with this type of the disease.
This approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS] = 18.6 versus 13.9 months; hazard ratio [HR] = 0.80; 95% CI: 0.640.99; p=0.0384) in the intention-to-treat wild-type (ITT-WT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.630.91; p=0.0024) in the ITT-WT population.
Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.
In lung cancer, Tecentriq is also approved in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Genentech has an extensive development program for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (866) 422-2377. More information is also available at http://www.Genentech-Access.com.
About the IMpower130 study
IMpower130 is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-nave patients with stage IV non-squamous NSCLC. The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomized (2:1) to receive:
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.
During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until further disease progression.
The co-primary endpoints were:
About lung cancer
According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2019, and NSCLC accounts for 80-85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:
A type of lung cancer called non-small cell lung cancer (NSCLC).
A type of lung cancer called small cell lung cancer (SCLC).
It is not known if Tecentriq is safe and effective in children.
Important Safety Information
What is the most important information about Tecentriq?
Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
Tecentriq can cause serious side effects, including:
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.
Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone include:
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the Tecentriq full Prescribing Information for additional Important Safety Information.
About Genentech in personalized cancer immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, were investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech in lung cancer
Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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FDA Approves Genentech's Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell...
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Global Cell Therapy Processing Market Growth, Demand, Industry Verticals, and Forecast upto 2022 – News Description
TheCell Therapy Processing marketreport [6 Year Forecast 2016-2022] focuses on Major Leading Industry Players, providing info likeCell Therapy Processing product scope, market overview, market opportunities, market driving force and market risks.Profile the top manufacturers of Cell Therapy Processing, with sales, revenue and globalmarket share ofCell Therapy Processingare analyzed emphatically bylandscape contrastandspeak to info.Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Cell Therapy Processing marketbusiness development trends and selling channelssquare measure analyzed. From a global perspective, It also represents overall Cell Therapy Processing industry size by analyzingqualitative insights and historical data.
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Summary
There are numerous indications that can be cured using cell therapies, and with increased R&D activities for cell therapies, the number of therapeutic uses is anticipated to increase in the near future. Some of the indications under investigation for the treatment using cell therapy are cerebral disorders such as Parkinsons disease and Alzheimers disease, and also cardiovascular disease. Cardiovascular disease could be treated using cell therapies with the aim to restore normal heart functions. Moreover, many studies are undergoing in the attempt to improve the safety and efficacy in treatment of different malignancies. Cell therapy could also be used to cure metabolic disorder such as diabetes mellitus type 1 where there is lack of insulin production in the patient. Researchers are also trying to restore normal liver and kidney function by introducing modified cells of respective origins. Presently, cell therapy could be a promising technique for the treatment of numerous conditions such as orthopedic, oncology, neurological and variety of autoimmune diseases. The increase in the potential of cell therapies in the treatment of diseases associated with lungs using stem cell therapies is anticipated to drive the markets growth in the near future. In addition, improved understanding of the role of stem cells in inducing development of functional lung cells from both embryonic stem cells (ESCs) and induced pluripotent stem (iPS) cells offers lucrative opportunities for the cell therapy processing markets growth. The rising significance of stem cell therapies provides further understanding of lung biology and repair after lung injury, and further a sound scientific basis for therapeutic use of cell therapies and bioengineering approaches in the treatment of lung diseases.
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This research report presents an in-depth analysis of the global cell therapy processing market by offering type, application and geographic regional markets. The report includes key inhibitors that affect various factors that help in growth of cell therapy processing. The report discusses the role of supply chain members from manufacturers to researchers. The report analyzes key companies operating in the global cell therapy processing market. In-depth patent analysis in the report will provide extensive technological trends across years and regions such as North America, Europe, Asia-Pacific and ROW.
The cell therapy processing market is mainly segmented into three major components: offering type, application and region. Based on offering type, the market is segmented into products (cell lines, instruments, among others), services (product design, process design, among others) and software (enabling software). Based on application, the market is categorized into cardiovascular diseases, bone repair, neurological disorders, skeletal muscle repair, cancer and others. The market is segmented by region into North America, Europe, Asia-Pacific and the ROW.
The cell therapy processing market is mainly segmented into three major components: offering type, application and region. Based on offering type, the market is segmented into products (cell lines, instruments, among others), services (product design, process design, among others) and software (enabling software). Based on application, the market is categorized into cardiovascular diseases, bone repair, neurological disorders, skeletal muscle repair, cancer and others. The market is segmented by region into North America, Europe, Asia-Pacific and the ROW.
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Global Cell Therapy Processing Market Growth, Demand, Industry Verticals, and Forecast upto 2022 - News Description
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PHATED to be: Yale researchers give shape to big data – Yale News
Scientists now have the ability to collect massive amounts of data on lifes most fundamental processes, such as the intricate choreography whereby a handful of embryonic stem cells give rise to trillions of specialized cells throughout the human body. But data doesnt always translate into knowledge unless the relationship of recorded data points can be presented in accurate, meaningful and visible ways.
The lab of Yales Smita Krishnaswamy, associate professor of genetics and computer science, has developed a new algorithm called PHATE that overcomes many of the shortcomings of existing data visualization tools, which are more susceptible to noise and distortion in the relationship of data points.
The panel above shows how PHATE visualizes the differentiation of human embryonic stem cells into neuronal cells, neural stem cells, cardiac cells, and endothelial cells, as compared to the visualizations created by three other technologies.A cleaner, more detailed representation is helpful, for example, for generating promising new hypotheses.
The researchers work is described Dec. 3 in the journal Nature Biotechnology.
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PHATED to be: Yale researchers give shape to big data - Yale News
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