Over 95% planned enrollment completed in Phase 3 oGVHD study; topline results anticipated by end of 2020

Conference Call and Webcast Today at 8:30 a.m. ET

MALVERN, Pa., March 27, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat rare and underserved ophthalmic diseases, today reported full year 2019 financial results along with a general business update.

We are extremely pleased with the progress we have made in enrolling patients in our Phase 3 clinical trial for OCU300, an orphan drug candidate for ocular graft versus host disease (oGVHD). Based on current enrollment, we anticipate topline results by the end of the year, commented Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen. The publication of preclinical data on OCU400 in Nature Gene Therapy earlier this month is a key achievement for this program. We continue to advance IND-enabling studies toward bringing this potential breakthrough modifier gene therapy platform to patients in a Phase 1/2a clinical trial for OCU400 in 2021. Similar to the situation with virtually all other biopharmaceutical companies, we are also assessing the potential impact of ongoing COVID-19 pandemic-related events on our programs and plans. We are grateful to healthcare professionals and others who are working hard to address and mitigate the challenges presented by the virus.

Business Highlights:

-- OCU300 (oGVHD) In December 2019, Ocugen announced 50% enrollment in its Phase 3 trial, and as of March 20, 2020, Ocugen has completed over 95% of the planned enrollment. Ocugen is anticipating topline results by the end of the year. -- OCU400 (AAV-NR2E3) On March 3, 2020, Nature Gene Therapy published preclinical data related to OCU400, supporting the use of nuclear hormone receptor gene NR2E3 as a genetic modifier and therapeutic agent to treat multiple retinal degenerative diseases and potentially serve as a broad-spectrum therapy for retinitis pigmentosa. -- EB-5 Loan Agreement On March 26, 2020, Ocugen drew down an additional $0.5 million under its loan agreement with EB5 Life Sciences, L.P.

Full Year 2019 Financial Results:

-- Ocugens cash, cash equivalents and restricted cash totaled $7.6 million as of December 31, 2019, compared to $1.8 million as of December 31, 2018. -- Research and development expenses for the year ended December 31, 2019 were $8.1 million compared to $10.3 million for the year ended December 31, 2018. General and administrative expenses for the year ended December 31, 2019 were $6.1 million compared to $5.8 million for the year ended December 31, 2018. -- Ocugen reported a net loss of $20.2 million, or $1.46 loss per share, for the year ended December 31, 2019, compared to a net loss of $18.2 million, or $3.67 loss per share, for the year ended December 31, 2018. -- The Company had 52,625,228 shares of common stock outstanding as of December 31, 2019.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the results and recent business highlights. Ocugens senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 5373849. To access a live audio webcast of the call on the Investors section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugens website for approximately 45 days following the call.

About Ocugen, Inc. Ocugen, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to treat the whole eye. Our Phase 3 small molecule drug candidate for ocular Graft Versus Host Disease (oGVHD), if approved, will be the first and only treatment for this orphan disease. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug one to many. And our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. For more information, please visit http://www.ocugen.com.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the SEC), including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

(tables to follow)

OCUGEN, INC.CONSOLIDATED BALANCE SHEETS(UNAUDITED)

December 31, December 31, 2019 2018 Assets Current assets Cash and cash equivalents $ 7,444,052 $ 1,628,136 Prepaid expenses and other current assets 1,322,167 313,499 Asset held for sale 7,000,000 Total current assets 15,766,219 1,941,635 Property and equipment, net 222,464 245,788 Restricted cash 151,016 150,477 Other assets 667,747 116,333 Total assets $ 16,807,446 $ 2,454,233 Liabilities and stockholders equity (deficit) Current liabilities Accounts payable $ 1,895,613 $ 3,277,525 Accrued expenses 2,270,045 1,402,750 Short-term debt, net 7,483,847 Derivative liabilities 1,741,222 Operating lease obligation 172,310 Other current liabilities 205,991 204,242 Total current liabilities 4,543,959 14,109,586 Non-current liabilities Operating lease obligation, less current portion 163,198 Long term debt, net 1,072,123 1,016,727 Other non-current liabilities 9,755 37,459 Total liabilities 5,789,035 15,163,772 Stockholders equity (deficit) Common stock 527,467 49,606 Treasury stock (47,864 ) Accumulated other comprehensive income 451 Additional paid-in capital 62,018,632 18,477,598 Accumulated deficit (51,479,824 ) (31,237,194 ) Total stockholders equity (deficit) 11,018,411 (12,709,539 ) Total liabilities and stockholders equity (deficit) $ 16,807,446 $ 2,454,233 - ---------- - - --------- -

OCUGEN, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)

Year ended December 31, 2019 2018 Operating expenses: Research and development $ 8,085,522 $ 10,321,397 General and administrative 6,077,097 5,819,111 Total operating expenses 14,162,619 16,140,508 Loss from operations (14,162,619 ) (16,140,508 ) Other income (expense) Change in fair value of derivative liabilities (3,187,380 ) 1,664,689 Loss on debt conversion (341,136 ) Interest income 1,214 19,213 Interest expense (1,767,836 ) (3,750,630 ) Other income (expense) (784,873 ) (12,428 ) Total other income (expense) (6,080,011 ) (2,079,156 ) Net loss $ (20,242,630 ) $ (18,219,664 ) Net loss per share of common stockbasic and diluted $ (1.46 ) $ (3.67 ) Weighted average common shares outstandingbasic and diluted 13,893,819 4,960,552 ------------- - ------------- -

Corporate Contact: Ocugen, Inc. Kelly Beck kelly.beck@ocugen.com +1 484-328-4698 Media Contact: LaVoieHealthScience Emmie Twombly etwombly@lavoiehealthscience.com +1 857-389-6042

Originally posted here:
Ocugen Provides Business Update and Full Year 2019 Financial Results - Associated Press

Recommendation and review posted by Bethany Smith

Dosing Initiated in PROPEL Phase 1/2 Trial of PR001 for Treatment of Parkinsons Disease with GBA1 Mutations

Preparations Underway to Initiate PROVIDE Phase 1/2 Trial of PR001 for Treatment of Type 2 NeuronopathicGaucher Disease in Mid-2020

IND for PR006 for Treatment of Patients with Frontotemporal Dementia with GRN Mutation Active; Initiation of PROCLAIM Phase 1/2 Trial Planned for Mid-2020

Cash Runway into First Half of 2022

NEW YORK, March 26, 2020 (GLOBE NEWSWIRE) --Prevail TherapeuticsInc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reported financial results for the full year ended December 31, 2019, and reviewed recent business highlights.

2019 was an important year for Prevail as we continued to make important clinical and regulatory progress across our portfolio of novel AAV9-based gene therapy candidates for neurodegenerative diseases and brought the company public, said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. Dosing has begun in our PROPEL clinical trial of PR001 for patients with Parkinsons disease with GBA1 mutations, or PD-GBA. Additionally, we are working to initiate three more Phase 1/2 clinical trials this year: the PROVIDE and PROGRESS trials of PR001 for the treatment of Type 2 and Type 3 neuronopathic Gaucher disease, or nGD, respectively, and the PROCLAIM trial of PR006 for the treatment of frontotemporal dementia patients with GRN mutation, or FTD-GRN potentially the first gene therapy for this condition to enter clinical trials. Our ability to advance multiple candidates towards the clinic over the last year reflects the dedication of our team, the potential reach of our platform, and the urgent need for novel potentially disease-modifying therapies for patients with these genetically-defined neurodegenerative diseases.

Recent Business Highlights and Updates:

Full Year 2019 Financial Results

About Prevail Therapeutics Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The company is developing PR001 for patients with Parkinsons disease with a GBA1 mutation (PD-GBA) and neuronopathic Gaucher disease; PR006 for patients with frontotemporal dementia with a GRN mutation (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinsons with GBA and OrbiMed, and is headquartered in New York, NY.

Forward-Looking Statements Related to PrevailStatements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential impact of COVID-19 on Prevails ongoing and planned clinical trials, business and operations; the potential of Prevails gene therapies to modify the course of neurodegenerative diseases; the anticipated timing of Prevails Phase 1/2 clinical trials of PR001 in PD-GBA and in nGD and Prevails clinical trial of PR006; and the potential impacts of Orphan Drug and Rare Pediatric Disease Designations. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevails novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevails gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

These and other risks are described more fully in Prevails filings with the Securities and Exchange Commission (SEC), including the Risk Factors section of the Companys Quarterly Report on Form 10-Q for the period ended September 30, 2019, filed with the SEC on November 12, 2019, the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2019, to be filed with the SEC on or about March 26, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Prevail Therapeutics Inc.Statements of Operations(in thousands, except share and per share data)

Prevail Therapeutics Inc.Balance Sheets(in thousands, except share and per share data)

Media Contact:Mary CarmichaelTen Bridge Communicationsmary@tenbridgecommunications.com

Investor Contact: investors@prevailtherapeutics.com

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Prevail Therapeutics Reports Full Year 2019 Financial Results and Business Highlights - BioSpace

Recommendation and review posted by Bethany Smith

For biotechnology companies, responding to a sudden public health crisis, like the coronavirus, can be risky business. It can take more than a year to develop a vaccine or treatment. By that time, the threat may be gone, leaving little or no demand for a drug.

The current coronavirus pandemic appears to be different.

The race to beat the pathogen is on, with many biotechs now expecting a large market for coronavirus therapies in 2021 or beyond.But the starting gun didn't fire right away when the virus began spreading late last year.

"There were a lot of companies that kind of felt once bitten, twice shy," saidJose Trevejo, chief executive of SmartPharm Therapeutics in Kendall Square.

Companies were shy because drug makers have been bitten in the past when they've hustled to confront an outbreak, only to see the danger subside and their efforts go to waste. That's what happened during a previous coronavirus scare the SARS outbreak of 2003, which ended before any vaccine maker could earn a buck.

"There was also Ebola, and then a lot of people forget about the swine flu the H1N1," Trevejo said. "So, I think a lot of big pharma were a bit hesitant to plunge fully into coronavirus."

In recent weeks, the industry's view has changed. At LabCentral, the shared workspace where Trevejo's gene therapy startup operates, more than a dozen companies have turned their attention to the coronavirus, including SmartPharm.

And that's just one lab in Cambridge.

The number of companies pursuing coronavirus drugs is constantly growing, according to Yasmeen Rahimi, co-head of biotechnology research at Roth Capital Partners, an investment banking firm in Newport Beach, Calif.

"I track COVID-19 on a daily basis," she said. "Almost every day we get 10 or 12 companies that are coming."

Rahimi said the most notable may be Moderna, another Cambridge biotech. It's the first company to begin testing a potential coronavirus vaccine on humans in the U.S.

Moderna didn't respond to an interview request. But in a public document this week, the company said that "a commercially-available vaccine is not likely to be available for at least 12-18 months."

Moderna doesn't think the virus will peter out by then. Instead, it is "scaling up manufacturing capacity toward the production of millions of doses per month."

That may not be enough, according to Dr. Lee Wetzler, an infectious disease specialist at Boston Medical Center.

"Just like the flu vaccine, you're talking not just millions of doses," said Wetzler, who is also a professor at Boston University School of Medicine. "Tens tens of millions of doses and even more."

Then again, Wetzler added, it's hard to predict what this previously unknown virus will look like a year from now. It's possible that the pandemic will be under control, which would be good for the world but maybe not so good for companies, like Moderna and others, investing in drugs to stop it.

There's a cautionary tale in theonce-hot biotech Vical, which received federal money to chase vaccines for anthrax, SARS and Ebola. The fear and the funding always faded before Vical could cross the finish line, said John Carroll, editor of Endpoints News, a biotech publication.

"What Vical did was just flame out," he said. "They weren't able to come up with a vaccine and, after repeated failures, they just couldn't make it anymore."

The risk of failure is well understood by James Sietstra, chief business officer of Totient, one of the startups at LabCentral that have shifted to the coronavirus. But he maintains that working on the coronavirus won't be futile, even if the disease runs its course before Totient can bring a drug to market.

"As a business case for us, this is a great proof point for the power of our platform," he said.

Sietstra said the same method Totient will use to attack the coronavirus could also be used against other diseases including the company's original target, cancer.

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Vaccine Development Is Risky Business. Biotechs Are Tackling The Coronavirus, Anyway - WBUR

Recommendation and review posted by Bethany Smith

Patients urged to seek official medical advice to prevent surge in unethical treatments outside clinical pathways

Vancouver, Canada, March 25, 2020 -The International Society for Cell & Gene Therapy (ISCT), the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cellular therapy into safe and effective therapies to improve patients lives, today announces it is discussing with scientific and industry organizations and regulators a range of actions against the proliferation of unproven and untested stem cellbased therapies with claims to treat COVID-19. It also urges patients and families to consult expert medical professionals for the most accurate available information on treatment options.

Organizations across the life science industry, including the cell and gene therapy (CGT) sector, are currently united in the key focus of finding evidence-based treatments and vaccines for the current COVID-19 pandemic. These therapies and vaccines could save vast numbers of lives globally, said Dr Daniel Weiss, MD, PhD, Chief Scientific Officer of ISCT. It is critical that these vital and urgent efforts are not hampered by unscrupulous companies profiting by offering false and unproven interventions. These false interventions can cause immense harm by eroding the confidence of the public, investors, and the wider communities in the medical and biopharma sectors at the very time it is needed most.

ISCT set up its Presidential Task Force in 2014 in its ongoing commitment to address the rise of commercially available unproven cell and gene therapy treatments. In October 2019, it formed a cell and gene therapy sector-wide coalition of organizations across the globe to combat the rise in the number of unproven commercial cell banking services. The PTF also publishes a biennial report detailing global CGT with market authorization which patients and physicians can utilize to make informed decisions on treatments. ISCT is currently in conversations with its consortia partners, as well as regulators and governments globally, regarding options to prevent organizations operating outside of current clinical guidance.

Prior to the current COVID-19 pandemic, ISCT identified that the unproven cell therapy market is currently worth up to USD 2.4 billion and involves approximately 60,000 patients annually, paying up to USD 40,000 per treatment. ISCT believes that during the current COVID-19 climate, the number of patients and the costs of these treatments will considerably increase.

The current climate of a quickly spreading COVID-19 infection and a lack of approved treatments creates a perfect storm that results in a plethora of unethical organizations offering unproven therapies. These organizations offering untested therapies outside of proper clinical pathways for COVID-19 create a real and immediate risk to life. These treatments often lack proof of efficacy, and potentially have a very high cost to desperate patients. Most importantly, these treatments produced with no evidence can be even more dangerous to the immediate health of patients and their communities, said Dr. Laertis Ikonomou, PhD, co-chair of the ISCT PTF on the Use of Unproven and/or Unethical Cell and Gene Therapy. ISCT will work with government agencies and regulatory bodies internationally to take action against those looking to profit from a pandemic that is affecting so many people across the globe.

About the International Society for Cell & Gene Therapy

Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists and industry partners with a shared vision to translate cellular and gene therapy into safe and effective therapies to improve patients lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory and Commercialization. Through strong relationships with global regulatory agencies, academic institutions and industry partners, ISCT drives the advancement of research into standard of care.Comprised of over 1700 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives and upcoming meetings, please visit:www.isctglobal.org,@ISCTglobal.

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ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies - PharmiWeb.com

Recommendation and review posted by Bethany Smith

REDWOOD CITY, Calif., March 23, 2020 (GLOBE NEWSWIRE) -- Codexis, Inc., a leading protein engineering company and developer of novel biotherapeutics, announces the signing of a strategic collaboration and license agreement with Takeda Pharmaceutical Company Limited (Takeda) for the research and development of novel gene therapies for certain disease indications, including the treatment of lysosomal storage disorders and blood factor deficiencies.

Under the terms of the agreement, Codexis will generate novel gene sequences encoding protein variants tailored to enhance efficacy as a result of increased activity, stability, and cellular uptake using its CodeEvolver protein engineering platform. Takeda will combine these improved transgenes with its gene therapy capabilities to generate novel candidates for the treatment of rare genetic disorders.

Our CodeEvolver platform technology enables the rapid engineering of novel genetic sequences that encode more efficacious proteins. The prospects of these improved sequences for the development of differentiated gene therapies for patients with rare diseases therefore holds great promise, stated John Nicols, Codexis President and CEO. Takedas expertise in developing novel treatments for patients with rare genetic disorders, and its commitment to developing the best possible gene therapies, makes them an ideal partner for our growing Novel Biotherapeutics business unit.

Gjalt Huisman, Codexis Senior Vice-President, and General Manager, Novel Biotherapeutics added, We are looking forward to working with Takeda to advance our pre-clinical assets for lysosomal storage disorders, and to broaden our biotherapeutics pipeline to now include blood factor disorders.

Terms of AgreementUnder the terms of the agreement, the parties will begin collaborative work on three initial programs. Codexis is responsible for the creation of novel enzyme sequences for advancement as gene therapies into pre-clinical development. Takeda is responsible for the pre-clinical and clinical development and commercialization of gene therapy products resulting from the collaboration programs. Under the terms of the agreement, in addition to the three initial programs, Takeda may initiate up to four additional programs for separate target indications. Subject to the terms of the agreement, Codexis is eligible to receive an upfront payment, reimbursement for research and development fees, development and commercial milestone payments, and low- to mid-single digit percentage royalties on sales of any commercial product developed through such initial programs and any other programs that Takeda may elect under the agreement. Back Bay Life Science Advisors served as strategic and financial advisors to Codexis.

About Codexis, Inc.Codexis is a leading protein engineering company that applies its proprietary CodeEvolver protein engineering technology to develop proteins for a variety of applications, including enzymes as biotherapeutics, as biocatalysts for the commercial manufacture of pharmaceuticals and fine chemicals, industrial enzymes, and for use in molecular diagnostics. For its Biotherapeutics pipeline, Codexis technology enables improvements in protein efficacy, through enhancement of activity, affinity, stability, as well as uptake by target cells. For more information, see http://www.codexis.com.

Forward-Looking StatementsTo the extent that statements contained in this press release are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including Codexis expectations regarding the prospects for the development and future commercialization by Takeda of novel gene therapies for specified target indications. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis control and that could materially affect actual results. Factors that could materially affect actual results include, among others: Codexis dependence on its licensees and collaborators; Codexis dependence on a limited number of products and customers; and potential adverse effects to Codexis business if its customers products are not received well in the markets. Additional information about factors that could materially affect actual results can be found in Codexis Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2020, including under the caption Risk Factors and in Codexis other periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Investor Contact: LHA Investor RelationsJody Cain, 310-691-7100jcain@lhai.com

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Codexis Signs Strategic Collaboration and License Agreement with Takeda to Advance Novel Gene Therapies for Rare Genetic Disorders - GlobeNewswire

Recommendation and review posted by Bethany Smith

Global Gene Therapy for Inherited Genetic Disorders Market: Overview

Rapid advances in mammalian DNA sequencing technologies over the past several years have enabled the identification of the aberrant genes responsible for a vast spectrum of genetic disorders. Gene therapy as a novel approach inarguably holds profound potential in finding universal therapeutic alternatives to treating inherited genetic disorders. Gene therapy for inherited genetic disorders entails introducing a functional copy of the defective gene to make up for the missing function, and can be accomplished using in vivo or ex vivo gene transfer.

Gene therapy for inherited genetic disorders has generated groundswell of interest in the research fraternity in finding cure for or in treatment of Mendelian genetic error causing rare diseases. Particularly, gene therapy in recent years has held promising potential in the treatment of a range of recessive gene disorders most notably sickle cell anemia, hemophilia, muscular dystrophy, cystic fibrosis, and other monogenic disorders. The axes of developments in the gene therapy for inherited genetic disorders market have been in the U.S., Europe, China, and Australia.

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Global Gene Therapy for Inherited Genetic Disorders Market: Notable Developments

Growing body of clinical studies done on mice models have unrivalled troves of preclinical data, which bodes well for the effectiveness of gene therapy for inherited genetic disorders. New approaches in the gene therapy for inherited genetic disorders market are being adopted to bring progress in this direction. In this regard, Salmeterol, a medicine approved for asthma, has shone a new light. The vasodilator to be used along with gene therapy has shown potential in increasing the effectiveness of the therapy for Glycogen storage disease type II (Pompe disease).

A team of investigator led by the researcher at Duke University Medical School discussed the preclinical data recently at 2019 annual meeting of the American Society of Gene & Cell Therapy. The preclinical data showed that the Asthma medicine reduces the accumulation of toxic glycogen accumulated in lysosome. The researchers concluded that it holds potential as an adjunctive therapy, and building on that may pave way for novel approaches on gene therapy for inherited genetic disorders.

Efforts to translate the findings of clinical research on gene therapy for inherited disorders to make the therapy a part of standard treatment has caught momentum in recent times. In this regard, vectors containing non-viral vectors have attracted the attention of scientists. A team of researchers at Fred Hutchinson Cancer Research Center in 2019 found that gold nanoparticles enable them to deliver gene-editing tools to blood stem cells in lab models. This might, they opined, pave way for more practicaland accessiblegene therapies for inherited disorders, notably for treating life-threatening blood disorders. Gene therapies were mediated by CRISPR. In the coming years they hope to collaborate with companies with commercial interest to develop the therapy for patient populations.

Some of the bigplayerseyeing promising stakes in the gene therapy for inherited genetic disorders market areSpark Therapeutics Inc., Orchard Therapeutics, Novartis AG, bluebird bio Inc., and BioMarin Pharmaceutical.

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Global Gene Therapy for Inherited Genetic Disorders Market: Key Drivers

Since 2000, scores of clinical trials involving patients with inherited genetic disorders have raised hopes of the medical fraternity of the potential of gene therapies. Thus far, more than 5000 clinical trials on gene therapy have been conducted, especially for hard-to-treat diseases. Diseases such as inherited blindness and leukemia have seen the efficacy and safety of gene therapies. Advances in bioengineering are expected to invigorate pre-clinical pipelines. In the not-so-distant future, success of more protocols will catalyze the prospects of the gene therapy for inherited genetic disorders market.

Further, advances have been made in viral and non-viral vectors with the purpose of making gene transfer more efficient, thereby boosting the gene therapy for inherited genetic disorders market. Particularly, new approaches emerged with the aim of making vectors more powerful.

Global Gene Therapy for Inherited Genetic Disorders Market: Regional Assessment

On the regional front, Asia Pacific bears considerable potential in the gene therapy for inherited disorders market. Of note, numerous strategic alliances have shifted their focus on the region, particularly China. The North America market has also been rising at a promising pace, driven by several gene-therapy tools and related drugs in the final stages of clinical trials. Favorable reimbursement models has also encouraged research into the gene therapy for inherited disorders.

Read Comprehensive Overview of Report @https://www.tmrresearch.com/gene-therapy-for-inherited-genetic-disorders-market

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Gene Therapy for Inherited Genetic Disorders Market Expected to Witness Significant Growth in the Forecast Years 2028 - Daily Science

Recommendation and review posted by Bethany Smith

After nearly a year as president and COO at Paragon Biosciences, Jim Robinson has jumped to Urovant Sciences, where he will be president and CEO of the urology-focused biotech, succeeding founding CEO Keith Katkin. Robinson will continue as a member of Urovants board of directors. His previous stops include Alkermes as president and COO and a number of positions at Astellas and Schering-Plough Pharmaceuticals.

At the same time as an $80 million partnership with Astellas, CytomX has recruited Eli Lilly vet Carlos Campoy as SVP and CFO. Most recently, Campoy served as CFO of Alder BioPharmaceuticals, helping complete its $2 billion sale to Lundbeck. Prior to that, Campoy was VP of finance, international at Allergan.

Bristol Myers former top dealmaker Paul Biondi whos currently serving as an executive partner at Flagship Pioneering has joined the board of directors at Seres Therapeutics, succeeding Flagship CEO Noubar Afeyan whos stepping down.

UK-based Immune Regulation has wooed the former CEO of SteadyMed Therapeutics (acquired by United Therapeutics) Jonathan Rigby to the helm of their company as CEO. Rigby cofounded Zogenix and earlier in his career served at Merck and Bristol Myers Squibb.

Shanghai-based EpimAb Biotherapeutics has enlisted Xinyi David Gu as CFO. Gu makes the hop over from Millennium Management, and prior to that served at Jefferies as VP and global pharmaceutical equity research analyst. In addition, Gu has held a post at McKinsey & Company.

After bagging $26 million in funding and earning fast track designation for its lead drug candidate, gene therapy company Genprex has recruited Michael Redman as EVP and COO and Catherine Vaczy as EVP and chief strategy officer. Redman was the former CEO and president of Oncolix for more than a decade. Prior to Oncolix he served in posts at Bone Medical, Opexa Pharmaceuticals and Zonagen, among others. Vaczy was a co-founder of NeoStem (now Caladrius Biosciences) and served at ImClone Systems (acquired by Eli Lilly).

Menlo Therapeutics has tapped Andrew Saik as CFO and treasurer. Saik will be based at the companys headquarters at Bridgewater, New Jersey. Most recently, Saik served as CFO of PDS Biotechnology. Prior to that, he was CFO at Vertice Pharma and Auxilium Pharmaceuticals helping in the $2.6 billion sale of the company. His previous experience includes stints at Endo Health Solutions and Valeant Pharmaceuticals.

Lisa Rojkjaer has joined Viracta Therapeutics as CMO, effective May 1. Prior to her appointment at the precision oncology company, Rojkjaer was CMO at Oslo-based Nordic Nanovector and global clinical program head, oncology global development at Novartis. Among her responsibilities will be steering Viractas lead program toward regulatory approvals for Epstein-Barr virus (EBV) positive lymphomas.

After welcoming Shafique Virani last week as chief corporate development officer, AI biotech Recursion has added Michael Secora as CFO. Secora joins the company after a decade of service at Laurion Capital, where he served as managing director and head of capital markets and venture. Near the same time as Viranis appointment last week, former Celgene exec Robert Hershberg was appointed to the companys board of directors. Hershberg served as Celgenes CSO and EVP and head of business development and global alliance.

Belgian orthopedics-focused biotech Bone Therapeutics has a new CBO, naming Stefanos Theoharis to the post. With experience in the cell and gene therapy arena, Theoharis was formerly SVP at Cell Medica and CBO at apceth GmbH.

Pravin Dugel has been appointed EVP and chief strategy and business officer of IVERIC bio, which concentrates on treatment for retinal diseases. Dugel brings more than 25 years of experience in the field to the New York biopharma and has also been managing partner at Retinal Consultants of Arizona and the Retinal Research Institute.

I-Mab has selected Gigi Feng to be its VP, global head of corporate communications starting on April 20. She will oversee all communications at the China-based biopharma, which centers on novel or highly differentiated biologics to treat diseases with significant unmet medical needs. Feng previously had communications roles at Amgen and Sanofi.

Meenu Chhabra, the CEO and president of Proteostasis Therapeutics, has hopped aboard the board of directors at Vasommune Therapeutics a company working on a treatment for Covid-19/pathogen-induced ARDS.

NASH biotech 89bio has welcomed Steven Altschuler as chairman to its board of directors. Altschuler serves as managing director of healthcare ventures at Ziff Capital Partners.

Immuneering whose current pipeline focuses on diseases such as cancer cachexia and metastasis has brought on three new additions to its scientific advisory board. Daniel Ahn, director of the GI Oncology Translational Research Working Group; Mitesh Borad, director of the cancer cell, gene and virus therapy lab at the Mayo Clinic Center for Individualized Medicine; and Bijan Nejadnik, the CMO and head of research at SanBio.

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Jim Robinson takes over the reins at Urovant; Carlos Campoy moves to CytomX - Endpoints News

Recommendation and review posted by Bethany Smith

Gene Therapy Market 2018: Global Industry Insights by Global Players, Regional Segmentation, Growth, Applications, Major Drivers, Value and Foreseen till 2024

The report provides both quantitative and qualitative information of global Gene Therapy market for period of 2018 to 2025. As per the analysis provided in the report, the global market of Gene Therapy is estimated to growth at a CAGR of _% during the forecast period 2018 to 2025 and is expected to rise to USD _ million/billion by the end of year 2025. In the year 2016, the global Gene Therapy market was valued at USD _ million/billion.

This research report based on Gene Therapy market and available with Market Study Report includes latest and upcoming industry trends in addition to the global spectrum of the Gene Therapy market that includes numerous regions. Likewise, the report also expands on intricate details pertaining to contributions by key players, demand and supply analysis as well as market share growth of the Gene Therapy industry.

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Gene Therapy Market Overview:

The Research projects that the Gene Therapy market size will grow from in 2018 to by 2024, at an estimated CAGR of XX%. The base year considered for the study is 2018, and the market size is projected from 2018 to 2024.

Leading manufacturers of Gene Therapy Market:

segmented as follows:

Global Gene Therapy Market, by Product

Global Gene Therapy Market, by Application

Global Gene Therapy Market, by Region

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Some important highlights from the report include:

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The Questions Answered by Gene Therapy Market Report:

And Many More.

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How Innovation is Changing the Gene Therapy Market - Packaging News 24

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Sickle Cell Anemia Therapeutics Market Analysis 2019" report has been added to ResearchAndMarkets.com's offering.

The Global Sickle Cell Anemia Therapeutics market is expected to reach $5,567.75 million by 2026 growing at a CAGR of 12.5% during the forecast period. Sickle-cell anaemia is a disease which is categorized by the existence of sickle-shaped erythrocytes. Sickle-cell anaemia is an inherited, lifelong blood disorder that impacts haemoglobin causing serious damage to the body.

Some of the key factors driving the growth of sickle-cell anaemia therapeutics market are the unmet medical needs and the increase in sickle-cell diseases. However, the side effects associated with current therapies and low awareness among individuals will surely impede the growth of this market.

Based on the Product Type, the pharmacotherapy segment is estimated to have a lucrative growth due to the potential launch of promising pipeline candidates such as Voxelotor, Crizanlizumab, Rivipansel, and Altemia. It is also estimated to lead the market, owing to a strong pipeline and several promising drug launches throughout the forecast period.

The key vendors mentioned are Addmedica, Baxter, Bioverativ, Bluebird Bio, Bristol-Myers, Squibb, Daiichi Sankyo, Eli Lilly, Emmaus Medical, Gamida Cell, Gilead Sciences, Global Blood Therapeutics, GlycoMimetics, HemaQuest Pharmaceuticals, Imara, Ironwood Pharmaceuticals, Johnson & Johnson, Mast Therapeutics, Merck Sharp & Dohme, Micelle BioPharma, and Modus Therapeutics.

Key Questions Answered in this Report:

Key Topics Covered:

1 Market Synopsis

2 Research Outline

3 Market Dynamics

3.1 Drivers

3.2 Restraints

4 Market Environment

4.1 Bargaining power of suppliers

4.2 Bargaining power of buyers

4.3 Threat of substitutes

4.4 Threat of new entrants

4.5 Competitive rivalry

5 Global Sickle Cell Anemia Therapeutics Market, By Medication

5.1 Introduction

5.2 Antibiotics

5.3 Hydroxyurea

5.4 Pain-Relieving Medications

5.5 Folic Acids

5.6 Antimetabolites

5.7 Vaccines

5.8 Analgesics

5.9 Other Medications

6 Global Sickle Cell Anemia Therapeutics Market, By Therapy

6.1 Introduction

6.2 Hydroxyurea

6.3 L-Glutamine

7 Global Sickle Cell Anemia Therapeutics Market, By Product Type

7.1 Introduction

7.2 Blood Transfusion

7.3 Bone Marrow Transplant

7.4 Gene Therapy

7.5 Pharmacotherapy

8 Global Sickle Cell Anemia Therapeutics Market, By Application

8.1 Introduction

8.2 Adult

8.3 Child

9 Global Sickle Cell Anemia Therapeutics Market, By End User

9.1 Introduction

9.2 Government

9.3 Home Healthcare

9.4 Hospitals

9.5 Infusion Centers

9.6 Private Clinics

9.7 Other End Users

10 Global Sickle Cell Anemia Therapeutics Market, By Geography

10.1 North America

10.2 Europe

10.3 Asia Pacific

10.4 South America

10.5 Middle East & Africa

11 Strategic Benchmarking

12 Vendors Landscape

12.1 Addmedica

12.2 Baxter

12.3 Bioverativ

12.4 Bluebird Bio

12.5 Bristol-Myers Squibb

12.6 Daiichi Sankyo

12.7 Eli Lilly

12.8 Emmaus Medical

12.9 Gamida Cell

12.10 Gilead Sciences

12.11 Global Blood Therapeutics

12.12 GlycoMimetics

12.13 HemaQuest Pharmaceuticals

12.14 Imara

12.15 Ironwood Pharmaceuticals

12.16 Johnson & Johnson

12.17 Mast Therapeutics

12.18 Merck Sharp & Dohme

12.19 Micelle BioPharma

12.20 Modus Therapeutics

For more information about this report visit https://www.researchandmarkets.com/r/kdd40y

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Global Sickle Cell Anemia Therapeutics Industry Analysis 2019 - Market Developments and Financials of Key Players - ResearchAndMarkets.com - Business...

Recommendation and review posted by Bethany Smith

ReportsnReports added a new report on The Gene Therapy in CVMD report that delivers the clean elaborated structure of the Report comprising each and every business-related information of the market at a global level. The in-depth study on the current state which focuses on the major drivers and restraints for the key players. Gene Therapy in CVMD Industry research report provides granular analysis of the market share, segmentation, revenue forecasts, geographic regions of the market and analytical tools such as SWOT analysis to generate a whole set of trade based studies regarding the Gene Therapy in CVMD.

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Gene therapies have been a point of discussion during the last several years as a potential curative option for a variety of disease indications. While mainly still in preclinical stages, gene therapy aims to treat or alleviate a disease by genetically modifying the cells of a patient. This report focuses on gene therapies in development across the 8MM for cardiovascular and metabolic disorders, including coronary artery disease, critical limb ischemia, diabetic foot ulcers, and Pompe Disease. In addition, this report provides an assessment of the pipeline, clinical, and commercial landscape of gene therapies in CVMD supplemented with a variety of KOL and payer perspectives.

Scope of this Report-This report combines KOL and Payer insights along with data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace. Components of the slide deck include Overview of CVMD and Gene Therapies: epidemiology and regulatory oversight Pipeline Assessment: regional breakdown, promising late-stage products, early-stage pipeline by molecule type Clinical Trials Assessment: trial breakdown by phase, leading industry and non-industry sponsors Market Access: considerations for reimbursement, pricing, and unmet needs Market Outlook: competitive assessment and key market events (2018-2025).

Reasons to buy this Report-

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Develop business strategies by understanding the trends shaping and driving the global CVMD gene therapy market. Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CVMD gene therapy market in the future. Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Single User License: US $ 7995

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Table of Contents in this Report-1. Preface1.1 Related Reports 41.2 Upcoming Related Reports 51.3 Abbreviations 62. Executive Summary 92.1 Key Findings 102.2 KOL and Payer Insight on CVMD Gene Therapy Competitive Landscape 113. Overview of CVMD Gene Therapy 123.1 What is Gene Therapy? 143.2 Gene Transfer Methods and Vectors Used for Gene Therapy 183.3 Viral Vectors vs. Non Viral Vectors 203.4 Therapeutic Gene Therapy Strategies Employed in CVMD 243.5 Gene Therapy in the 8MM 254. Epidemiology Analysis 314.1 Coronary Artery Disease 334.2 Peripheral Artery Disease 344.3 Peripheral Artery Disease with Critical Limb Ischemia 354.4 Systolic Heart Failure 364.5 Diabetic Foot Ulcers 374.6 Diabetic Neuropathy 384.7 Pompe Disease 395. Pipeline Assessment 405.1 CVMD Gene Therapy Pipeline in the 8MM 425.2 Pipeline Products Phase III 435.3 AnGes MGs Collategene 445.4 Angionetics Generx 455.5 ViroMeds Donaperminogene Seltoplasmid 465.6 Renovas RT-100 495.7 Pipeline Products Phase II 505.8 ID Pharmas DVC-10101 515.9 Juventas JVS-100 525.10 UFs Gene Therapy to Activate Acid Alpha Glucosidase for Pompe Disease 546. Clinical Trials Mapping and Design 556.1 Clinical Trial Mapping 576.2 Clinical Trial Design 597. Pricing and Reimbursement Strategies Payer Perspective 607.1 Current CVMD Space 627.2 Challenges Associated with Reimbursement of Novel CVMD Therapies 637.3 Prospective Payer Strategies for CVMD Gene Therapies 648. Market Outlook 658.1 Phase III CVMD Gene Therapy Pipeline 678.2 Key Launch Dates for Phase II and III CVMD Gene Therapy Pipeline 719. Appendix 729.1 Sources 739.1 Methodology 749.2 Primary Research 759.3 About the Authors 76

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Gene Therapy in CVMD Report- Growth Analysis, Future Trends, Size Estimation, Insights and Share Analysis By 2026 - Stock Market Herald

Recommendation and review posted by Bethany Smith

Gene Therapy Products market research report looks at the key aspects of the market including its market improvement, development, position and others. The industry inquiries in this report provide an examination and data as specified by classes. It underlines the global key manufacturers and analyzes the market competition landscape. The report also comprises of a bottomless knowledge on market definition, market drivers and market restraints, classifications, applications, and engagements. What is more, Gene Therapy Products Market report conducts analysis on sales (consumption) of market, focuses on the top players to assess their sales, price, revenue and market share with volume and value for each region.

Global gene therapy products market is set to witness a substantial CAGR in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Rising cancer cases and unused potential for emerging markets are the major factors for the growth of this market.

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Few of the major competitors currently working in the globalgene therapy products marketareAdaptimmune., Anchiano Therapeutics, bluebird bio, Inc., CELGENE CORPORATION, GlaxoSmithKline plc., Merck KGaA, Novartis AG, Achieve Life Sciences, Inc., Spark Therapeutics, Inc., Abeona Therapeutics, Inc, Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis, Inc., CRISPR Therapeutics, Intellia Therapeutics, Inc and Gilead Sciences,Inc. among others.

Market Definition:Global Gene Therapy Products Market

Gene therapy or human gene therapy is a process which is used to modify gene for the treatment of any disease. Plasmid DNA, bacterial vector, human gene editing technology and viral vectors are some of the most common type of gene therapy products. The main aim of the gene therapy is to replace the dysfunctional genes. Somatic and germline are some of the most common type of the gene therapy.

Complete report on Global Gene Therapy Product Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Segmentation: Global Gene Therapy Products Market

Gene Therapy Products Market : By Product

Gene Therapy Products Market : By Application

Gene Therapy Products Market : ByGeography

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Key Developments in the Gene Therapy Products Market:

Gene Therapy Products Market Drivers

Gene Therapy Products Market Restraints

Competitive Analysis: Gene Therapy Products Market

Global gene therapy products market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of gene therapy products market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key questions answered in the report :-

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Data Bridge Market Researchis a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others.

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Gene Therapy Products Market : Revenue Overview, Business Analysis 2020-2026 || Leading Players Adverum, agtc, Arbutus Biopharma, Audentes...

Recommendation and review posted by Bethany Smith

Viralym-M recently received EMA PRIME and U.S. FDA RMAT designations

Phase 3 pivotal and Phase 2 proof-of-concept studies to be initiated for Viralym-M in 2020 targeting six devastating and life-threatening viral pathogens in immunocompromised patients

AlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, today announced it has been granted Orphan Drug Designation from the European Medicines Agency (EMA) for Viralym-M (ALVR105) as a potential treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplantation (HSCT). Viralym-M is the companys lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, being developed for the treatment and prevention of serious viral diseases caused by six commonly occurring, devastating viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, adenovirus, and JC virus. Viral diseases are a primary reason for poor outcomes in transplant patients, resulting in potentially devastating and life-threatening consequences.

In addition to Orphan Drug Designation, Viralym-M has been granted PRIority MEdicines (PRIME) designation from the EMA and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). Viralym-M is one of only seven investigational therapies, to date, to receive both PRIME and RMAT designations from the EMA and FDA, respectively. AlloVir plans to initiate Phase 3 pivotal and Phase 2 proof-of-concept studies with Viralym-M in 2020 targeting six commonly occurring, devastating and life-threatening viral pathogens.

At AlloVir, we are committed to advancing allogeneic, off-the-shelf novel T-cell therapies with the potential to improve the way we treat and prevent devastating viral diseases, said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. The Orphan Drug Designation by the EMA acknowledges the critical need for new treatment options for patients who have undergone stem cell transplant and are at risk of the serious consequences of viral diseases. Also, leveraging PRIME and RMAT designations, we are working to quickly advance Viralym-M through late-stage clinical development to bring, what we believe to be a transformative new therapy, to patients in the U.S., European Union and eventually around the world.

The EMA grants Orphan Drug Designation status for products intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, and where the product represents a significant benefit over existing treatments. Orphan Drug Designation provides companies with certain benefits and incentives in the EU, including a 10-year period of market exclusivity after product approval, reduced regulatory fees and protocol assistance.

About Opportunistic Viral Diseases

In healthy individuals, virus-specific T-cells from the bodys natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common, with potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic HSCT and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

About Viralym-M (ALVR105)

AlloVirs lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received Viralym-M, demonstrated a predefined criteria for a complete or partial clinical response, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms. The company plans to initiate pivotal and proof-of-concept studies with Viralym-M in 2020 for treatment and prevention of severe and life-threatening viral diseases.

Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from European Medicines Agency (EMA).

About AlloVir

AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVirs investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.

AlloVir is an ElevateBio portfolio company. More information can be found at http://www.allovir.com.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, Emerson Collective, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

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European Medicines Agency Grants Orphan Drug Designation to AlloVir's Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -...

Recommendation and review posted by Bethany Smith

The development of bone marrow transplantation procedures is widely considered one of the greatest victories in the war against cancer. The vast majority of bone marrow transplant recipients are patients with various forms of blood cancers, such as leukaemia, lymphoma or multiple myeloma. A real game changer, bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to over 85%.

Unfortunately, however, patients receiving bone marrow transplants are at high risk of developing Graft versus Host Disease (GvHD), a life-threatening complication that occurs when the transplanted cells from the donor the graft identify the transplant recipient the host as foreign.

This triggers an immune reaction that can wreak havoc in the transplanted patients body as it is attacked by the donated cells. This can occur from just days (in the case of acute GvHD) up to months or years (for chronic GvHD) after the haematopoietic cell transplantation (HCT) procedure has taken place.

The mortality rate of acute GvHD is very high in the case of grade 4 GvHD, it is over 90%. The overwhelmingly positive preliminary response of patients to CBD in preventing and treating GvHD shown in early trials, could be the key to significantly decreasing the incidence of this terrible condition.

Before we go on, there is a distinction to be made between a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue, as may be the case in liver or heart transplants, and GvHD, which occurs when the while blood cells in the donors reject the recipient.

There are two types of bone marrow transplant: autologous (from the patients own stem cells) and allogeneic (stem cells from a donor). It is in the latter where GvHD may occur.

GvHD from allogeneic bone marrow transplants can manifest itself in many forms and degrees; ranging from mild, moderate or severe, to potentially fatal for the patient. Acute GvHD can cause rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhoea, jaundice; and may attack the lungs, liver and eyes. It is often associated with chronic illness, infections, disability, reduced quality of life, and is a major cause of morbidity and mortality following HCT.

Researchers estimate that despite aggressive preventive measures with immunosuppressive treatments, 30% to 50% of transplanted patients whose donors were fully matching siblings and 50% to 70% of patients whose donors were unrelated to them develop some level of GvHD.

Though it may sound surprising, currently there are no FDA approved therapies for either the prevention or treatment of acute GvHD.

Enter Kalytera Therapeutics, a clinical-stage pharmaceutical company aiming to develop cannabidiol (CBD) for the treatment of serious diseases. The companys drug development expertise and intellectual property portfolio put it at the forefront in the development of CBD-based medicines for a range of important unmet medical needs. Currently, its resources are being focused mainly on mitigating the effects of GvHD following bone marrow transplantation.

Kalytera Therapeutics lead programme, in which we are evaluating CBD for the prevention and treatment of GvHD, is in late-stage clinical testing. Kalytera Therapeutics have an ongoing open label Phase 2 clinical study to evaluate the pharmacokinetic profile, safety and efficacy of CBD for the prevention of acute GvHD with encouraging preliminary results; we are currently approaching the end of cohort 2. A series of Phase 1 studies requested by the FDA, such as the effect of food intake on the absorption of oral CBD, have also been completed.

At this stage, Kalytera Therapeutics are ready to plan a meeting with the FDA to discuss the possibility of starting a pivotal study later this year. Following the approval of Epidiolex for Dravet Syndrome by GW Pharma, the FDA has encouraged that Kalytera apply for a 505(b)2 regulatory pathway, which provides manufacturers of some types of drugs to apply for FDA approval without performing all the work required in a new drug application.

Kalytera Therapeutics have also received a Fast Track Designation to aid in the development and expedite review of drugs intended for serious or life-threatening disease and addressing an unmet medical need, for the companys CBD products for prevention and treatment of acute GvHD. This could accelerate the approval process for these products.

The obvious first step in attempting to prevent GvHD is to find donor cells that match the genetics of the immune system of the transplant recipient as closely as possible. But even in the ideal case of the donors being a sibling, the patient still must rely on drugs specially developed to cause immunosuppression of the donor cells, through either T-cell depletion or drugs. Treatments usually used for this include methotrexate, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil and antithymocyte globulin (ATG), as determined by each medical team and institution.

When it comes to treating GvHD, the grafts immune cell activation needs to be suppressed with medication, so that donor-host immune tolerance can be established once again. Most patients are given corticosteroids, which directly suppress the donors immune cell attack on the hosts tissues. This also raises the risk of infection and the relapse of cancer.

As of now, there are guidelines but there is no standard treatment for either prevention or treatment of acute GvHD. Only 30% to 50% of patients with moderate to severe GvHD respond to corticosteroids, leaving many at risk of fatal outcomes. Everyone in the healthcare system should be aware that more research is necessary to discover better treatment options to reduce the rates of mortality and morbidity in transplantation patients.

The programme Kalytera is now implementing is based on previous Phase 2a clinical trials, which showed outstanding preliminary results in the prevention of the disease by giving patients CBD orally. In the first study, 48 patients received CBD for seven days prior to the bone marrow transplant procedure and for 30 days thereafter, as opposed to a group of 101 historical controls who had been given the usual GvHD prophylaxis and treated in the same BMT unit by the same medical team.

Remarkably, results showed none of the 48 patients had developed acute GvHD in the 30 days of treatment with CBD. Those who developed GvHD did so within a median time of 60 days, whereas the control group of 101 historical controls began to develop acute GvHD in a median time of 20 days only (ranging from nine to 137).

In the CBD treated group, the rates of grade 2 to grade 4 acute GvHD by day 100 were 12.1%, compared with 46% in the control. The rate of severe grade 3 to grade 4 was 5%, compared to 10% in the control. Equally important is the finding that CBD was also safe and well tolerated, with no severe adverse events attributed to its consumption. This is consistent with safety data previously reported on CBD administered to humans, even with three to four times higher doses and even when taken over extended periods of time.

In light of these encouraging initial results, it was decided to test the efficacy of a prolonged treatment covering 100 days: the time window in which acute GvHD usually occurs. In a second study, 12 patients were administered CBD at the same dose starting from seven days before the bone marrow transplant procedure until 100 days post-transplantation. No safety issues were observed here either and only one noncompliant patient, representing 8% of the CBD treatment group, developed acute GvHD; compared to a 46% incidence at the same institution in the historical group of 101 patients described above. This is despite the fact that the majority of the patients (10 out of 12) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors, which would normally increase their chance of developing GvHD.

In a third Phase 2a study, which was performed for treatment of already sick patients, 10 patients with acute GvHD, who were refractory to standard treatment with high dose steroids (only 60% of patients respond to first line therapy with high dose steroids), were administered daily doses of CBD for up to three months. Strikingly, nine of the 10 patients enrolled in the study responded to treatment, seven of them achieving complete remission of GvHD and two more achieving a near-complete response.

These results are impressive when we take into account that the 12-month mortality rate among patients with grade 3 and grade 4 GvHD who do not respond to steroids exceeds 60% and 80%, respectively. Indeed, these preliminary results compare favourably with the results of the historical control group of 29 patients with steroid-refractory grades 3 and 4 GvHD, among which 26 patients died from GvHD and its complications.

With a median follow-up period of 13 months, six patients were still alive. Two patients died from leukaemia relapses, and two patients died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment. This underlines the urgency of developing a product that can prevent and treat GvHD.

On the list of the 10 most expensive medical procedures, allogeneic BMT ranked fourth; while autologous BMT, at less than half the outrageous cost, still made it to the eighth place. Depending on the country and institution, costs range from tens of thousands to hundreds of thousands of dollars per procedure. The need and incentive to increase the rate of success are indisputable.

The life-saving ability of Kalyteras CBD products for the prevention and treatment of acute GvHD, currently classified as an orphan disease, means the company has good chances of obtaining premium pricing for a course of treatment. Over 20,000 patients suffer from acute GvHD following bone marrow transplantation in the six major markets of the US, Germany, the UK, France, Spain and Japan every year.

According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential market for a successful drug for prevention and treatment of GvHD in the seven major jurisdictions of the US, Germany, France, Italy, Spain, the UK and Japan is estimated to be over $408m in 2018; and could grow to approximately $1.3bn by 2027.

Once Kalyteras CBD products are approved by the FDA, the company believes that treating physicians would not be expected to prescribe anything other than its approved formulation of CBD (as opposed to a non-approved CBD that might be available online or from other commercial sources), especially since patients are often in isolation in the intensive care unit. It is safe to assume that neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD in the jurisdictions where Kalytera intends to market its CBD product.

Conducting proper, large scale clinical trials with CBD is of utmost importance. Although in some areas CBD seems to be generally safe in the broader healthy population, it can be harmful to some groups, such as young adults, women of childbearing age, pregnant women, children, people with known heart conditions or low blood pressure, and the elderly.

Despite all the hype about the multiple health benefits of cannabis-based products trumpeted by many (though not clearly stated due to possible risks of liabilities for unsubstantiated claims), so far only one CBD-based drug has received FDA approval for the treatment of two rare and serious types of epilepsy.

Contrary to popular belief and anecdotal evidence, CBD is not a biologically inert compound. Rather, CBD has a complex pharmacokinetic and pharmacodynamic profile similar to any other medication with the potential to interact with other medications and medical conditions. CBD is metabolised in the liver by enzymes responsible for metabolising a large percentage of other drugs. When taken concomitantly, CBD may reduce or neutralise the intended action of those other medications. Kalytera has completed drug to drug interaction testing in vitro and is now planning to start testing in healthy subjects.

CBD oil can have negative side effects too, such as drowsiness, drop in blood pressure when taken in large doses, being potentially harmful for people with low blood pressure. Other problems are dizziness or light-headedness, appetite changes, diarrhoea, hormonal changes, hypokinesia and resting tremor when used for epilepsy. In psychotic disorders it has side effects too, but they are milder than on other drugs used until today. It can benefit some Parkinsons patients, but not all of them.

Kalytera has a solid, experienced leadership team and very strong intellectual property portfolio. We have three issued US and European patents covering the use of CBD in the prevention and treatment of GvHD, as well as four orphan drug designations for the treatment and prevention of GvHD in the US and Europe.

Our promising preliminary results indicate we will be able to help BMT patients and their donated bone marrow get along better. This will greatly improve patients quality of life, productivity and life expectancy by keeping them GvHD free.

Dr Sari SagivStero Biotechs+972 36176173david@sela.co.il

Please note: Kalytera Therapeutics Inc. have recently acquired Stero Biotechs.

This article will appear in the second issue ofMedical Cannabis Network which will be available to read in April 2020.

Excerpt from:
Kalytera Therapeutics: improving bone marrow transplants with CBD - Health Europa

Recommendation and review posted by Bethany Smith

In severe cases, it can also cause deadly hardening of internal organs like the lungs

MADISON, Wis. A year ago, Chuck Beschta couldn't walk more than a few minutes without stopping to rest.

"Just going out and doing normal activities outside raking the lawn mowing the grass shoveling the driveway whatever;snow blowing, those became impossible."

After months of testing he was diagnosed with severe scleroderma, which was hardening his skin but even worse. it was hardening his lungs, making it hard to breathe.

Scleroderma is an autoimmune rheumatic disease where an overproduction of collagen produced in the body tissues.

But in severe cases, it can also cause deadly hardening of internal organs like the lungs, giving some patients little hope of surviving.

Chuck's case was getting more dire.

"He was getting worse despite the best therapy we had to offer," explained Dr. Kevin McKown, a rheumatologist at the University of Wisconsin Hospital in Madison

Dr. McKown recommended a stem cell transplant newly approved for scleroderma to reboot chucks immune system.

"There's a process by which they try to remove the autoreactive immune cells, the cells that are caught in the immune process and then they infuse that back in and hope that the body will basically take up and graft that immune system

Rheumatologists at University of Wisconsin Health tested the treatment since they have already been conducting bone marrow transplants for decades.

Surgeons take out a sample of the patient's bone marrow, isolate the stem cells, and use radiation and chemotherapy to clean out their immune system. The same stem cells are later injected back into the patient's immune system with the hope that new cells will grow and the system is rid of the bad ones.

The process is dangerous when the cells are taken out because the patient's immune system is more vulnerable, making infections more likely to occur.

Chuck saw almost immediate results. His skin was softer and his breathing improved.

He hopes his scleroderma has been cured.

"I think we can be optimistic and so far the people who have been followed out as far as 10 years out don't seem to be getting it back," said Dr. McKown.

After four and a half years, 79% of patients who underwent the treatment were alive without serious complications compared to 50% that were treated with the original drugs.

Without a transplant, less than half the patients, like Chuck, who have diffuse scleroderma and severe lung disease live 10 years past diagnosis. stem cell transplants are commonly used to treat leukemia and lymphoma, cancers that affect the blood and lymphatic system.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

More:
YOUR HEALTH: A rare disease that hardens the skin - WQAD.com

Recommendation and review posted by Bethany Smith

Evolutionary dynamics in hematopoiesis

Cells accumulate mutations as we age, and these mutations can be a source of diseases such as cancer. How cells containing mutations evolve, are maintained, and proliferate within the body has not been well characterized. Using a quantitative framework, Watson et al. applied population genetic theory to estimate mutation accumulation in cells in blood from sequencing data derived from nearly 50,000 healthy individuals (see the Perspective by Curtis). By evaluating how mutations differ between blood cell populations, a phenomenon known as clonal hematopoiesis, the researchers could observe how recurrent mutations can drive certain clonal lineages to high frequencies within an individual. The risk of specific mutations, some of which are associated with leukemias, rising to high frequencies may therefore be a function of cellular selection and the age at which the mutation originated.

Science, this issue p. 1449; see also p. 1426

Somatic mutations acquired in healthy tissues as we age are major determinants of cancer risk. Whether variants confer a fitness advantage or rise to detectable frequencies by chance remains largely unknown. Blood sequencing data from ~50,000 individuals reveal how mutation, genetic drift, and fitness shape the genetic diversity of healthy blood (clonal hematopoiesis). We show that positive selection, not drift, is the major force shaping clonal hematopoiesis, provide bounds on the number of hematopoietic stem cells, and quantify the fitness advantages of key pathogenic variants, at single-nucleotide resolution, as well as the distribution of fitness effects (fitness landscape) within commonly mutated driver genes. These data are consistent with clonal hematopoiesis being driven by a continuing risk of mutations and clonal expansions that become increasingly detectable with age.

The rest is here:
The evolutionary dynamics and fitness landscape of clonal hematopoiesis - Science Magazine

Recommendation and review posted by Bethany Smith

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Story continues

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

More here:
Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Yahoo Finance

Recommendation and review posted by Bethany Smith

Washington University School of Medicinein St. Louis released a newstudyabout the effectiveness of immunotherapy based on the age of the cells used. The study, published in the journalDevelopmental Cell,showed that these natural killer cells seem to be more effective when they are young. Natural killer (NK) cells, as they're called, are used in immunotherapy to treat cancer using the body's immune cells or immune cells from a matched donor.

"We are trying to improve the effectiveness of immunotherapy for more patients," said senior author Christopher M. Sturgeon, Ph.D., an assistant professor of medicine.

Typically, NK cells used in investigational immunotherapy are adult and come from the patient or donor bone marrow. While these therapies can work, they don't work for everyone.

In contrast, young NK cells do not use the patient's cell or donor cells. These early NK cells, typically formed in the yolk sac in the early embryo, are instead able to be created with human pluripotent stem cells. They can be manufactured quickly by most academic medical centers, thus eliminating the time it takes to process patient's or donor's cells for typical NK cell therapy.

"This special source of natural killer cells has the potential to fill some of the gaps remaining with adult NK cell therapy. There is early evidence that they are more consistent in their effectiveness, and we would not need to process cells from a donor or the patient. They could be manufactured from existing cell supplies following the strict federal guidelines for good manufacturing practices. The characteristics of these cells let us envision a supply of them ready to pull off the shelf whenever a patient needs them," Sturgeon said.

Instudieswith mice using the lab-developed human pluripotent stem cells to create early NK cells, researchers found positive results. These cells were significantly better at degranulation than adult NK cells. Even cells from umbilical cord blood did not respond as well as the early NK cells. Additionally, early NK cells are a particular type of short-lived immune cell, meaning that even if the cells cause harm, they aren't in the body for very long. However, NK cells, in general, do not attack the body's healthy tissues significantly, unlike many T cell therapies.

"Based on their unique behavior alone, there is one small clinical trial of these cells that is ongoing. Now that we know how to manufacture them and how they work, it opens the door for more trials and for improving upon their function, " Sturgeon said.

More research will need to be put into understanding why these special cells only show up in the early embryo and where they go after.

The origin and why they work so well is still a complete mystery.

"We can only speculate at this point, but it's possible that during early embryonic development, when there is so much rapid cell division, these cells are there as a surveillance mechanism to protect against pediatric cancers or infection," he said.

In addition to the early NK cells, pluripotent stem cells also have the potential to bring about many other different cell types, creating more possibilities.

Here is the original post:
Study Shows Development of Young Cells Could be New Option in Cancer Care - BioSpace

Recommendation and review posted by Bethany Smith

We live in a world of verbs. We eat and drink. We work. We play. We scroll. We run, read and riff about the latest news coming out of D.C. We love, listen and learn. Every moment of every day is about doing. These verbs no matter which you engage in form and define our lives.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

Yet, wellness expertMichael Roizen, MD, says we treat one of the most vital verbs of every 24-hour cycle sleep as a footnote, rather than the main text.

Sleep has become a cultural sacrificial lamb, Dr. Roizen says. Wed rather work late than get enough ZZZs. Wed rather binge on Bravo. Wed rather stalk social media. Or maybe our bodies just cannot shut down, or health problems make it hard to fall or stay asleep.

In any case, the reality is a harsh one, he says. Our lack of sleep isnt just a boon for the coffee shop industry. Its slowly killing us, Dr. Roizen says.

Dr. Roizen doesnt take a lack of sleep lightly. In fact, he says people dont put lack of sleep in the same category as cigarettes or obesity because fatigue is more of a behind-the-scenes health threat one that has a steady, creeping effect on our bodies. But the risks associated with lack of sleep are big.

Heres how it works: While youre sleeping, your body and brain cycle through various stages ranging from light sleep to deep sleep. You go through that cycle several times a night. It sure feels like nothing is going on after all, youre not aware of anything, except maybe that wacky dream about a tornado, a marching band and your seventh-grade math teacher. Thats maybe one of the reasons people dont give sleep as much attention as they should: They dont feel anything the way they feel exercise or a change in eating habits. So its easy to think that sleep is, well, just a whole lot of nothing.

But thats not the case. When youre closed for business, your bodys cells start their work. Think of the inside of your body as a big factory of shift workers, Dr. Roizen says. Cells clock in when you shut down. All day long, your body at work, during exercise, while youre going about your day has been put through a series of cellular stresses. For example, when you use your muscles, they can experience little microscopic tears. That same kind of stress happens all over your body in all kinds of organs, tissues and systems throughout the day.

To maintain itself and recover from these cellular insults, your body needs a repair crew. Enter your shift workers. While youre sleeping, theyre repairing your muscles, growing and strengthening neurons in your brain, fortifying your bodys damaged cells, he explains. These cells cannot do their jobs optimally unless your body is shut down and in deep sleep.

So you can imagine what happens if you dont give these cellular fixers enough time to work. Your body never gets fully repaired, making you weaker, more susceptible to further insults, and a lot less healthy. In practical terms, Dr. Roizen says, that means lack of sleep can contribute to immune problems, memory issues, higher stress levels and even obesity. Because your brain never fully rids of its waste products (the poop from your brain cells is removed at night, and is done more efficiently the longer you sleep), you can develop inflammation in your memory centers as well.

Yes, perhaps one of the greatest effects of lack is sleep is a high inflammatory response, which is your bodys way of fighting problems. When this response is at high levels all the time because it never shuts down, Dr. Roizen says that leads to a sort of friendly fire within the body: Your attacking immune cells begin to damage the healthy ones (and not just in your brain) putting you at an increased risk for heart disease, diabetes and arthritis. (Heck, research has even shown that lack of sleep even increases hostility in relationships; the fallout can trigger higher stress, which has damaging effects on overall health).

These bodily damages work in various ways, Dr. Roizen says. But if you think about your bodys function as a massive game of dominoes, you can see how it plays out. When you dont get enough sleep, you feel fatigued. When you feel fatigued, your body wants to raise energy levels, so it reaches for the fastest solution: sugar. When you reach for sugar, you gobble up stacks of cookies. And when you do that day after day after day, you gain a lot of weight.

Yeah, yeah, yeah, you say. Youve heard it all before. Get more sleep. Sleep eight hours. Easier said than done, especially if you have a complex cocktail of problems that make is difficult to sleep (pain, hormonal issues, obesity, urge to urinate, and so many other things can disrupt sleep cycles). Like many other health issues, Dr. Roizen emphasizes that sleep is one in which you may need to consider lifestyle and medical tactics to determine what will work best for you.

But you can also use food and nutrients to ease into some possible solutions to help change your verbs from tossing and turning to sweet dreaming. (As long as that sweet dreaming doesnt actually include sweets!)

MVPs: No magic sleep-inducing piece of fruit or secret ingredient will induce drowsiness (though, as youll see in the following, some are better than others). But Dr. Roizen says setting yourself up with a good last meal of the day can help prepare your body for sleep. Research shows that having meals high in fiber and low in foods with saturated fat and simple carbs (sugar) should help. So thats why a dish like beans, grilled fish or chicken, and a large side of vegetables is the best meal choice to help your body prepare to shut down (and as weve learned, the earlier you eat it, the better).

One recent study in The Journal of Clinical Sleep Medicine found that this kind of meal was associated with people falling asleep faster in less than 20 minutes, in fact. When subjects consumed more saturated fats and sugar, the process took closer to 30 minutes. If you have the choice (and you do!), make your protein fish, which, when eaten regularly, has been linked to helping prevent poor sleep.

Key Players: The two nutrients most associated with better sleep are magnesium and tryptophan. Youve heard of tryptophan; its all over the headlines in late November as the reason why you want to zonk out after eating a big plate of Thanksgiving turkey. Although tryptophan may not actually make you tired after a big holiday meal, the food that contain it, or magnesium, are certain good options if youre trying to improve your sleep quality. Tryptophan is an amino acid that converts to the body clock regulating hormone and melatonin. Foods that contain it include egg whites, soybeans, chicken and pumpkin seeds. And when you choose your vegetables for dinner, consider a leafy green like spinach that contain magnesium.

Cut From the Team: Feeling cravings at night? Dont be tempted by a midnight snack. Research on circadian rhythm and eating cycles reveals that midnight is actually the worst time to eat even if you think you just need a little something to make yourself more comfortable. Instead, have a fiber-rich dessert before the sun sets for example, a big bowl of berries or a pear. The fiber will slow things down so you feel full longer and thus less likely to crave something later at night.

The Sub Shop: Snooze Foods

This article was adapted from the best-selling book What to Eat When by Michael F. Roizen, MD, and Micheal Crupain, MD, MPH with Ted Spiker (2018 National Geographic Books)

Go here to see the original:
What to Eat When You Can't Sleep - Health Essentials from Cleveland Clinic

Recommendation and review posted by Bethany Smith

This article was medically reviewed by Carolyn Swenson, M.D., an assistant professor of obstetrics and gynecology and member of the Prevention Medical Review Board, on March 27, 2020.

Menstrual cycles have a long list of nicknames that are charmingly dark: the curse, shark week, the blob, crimson tide, and so on. But when it comes to periods getting heavier than usual, the term that should be used most is potential problem.

Heavy menstrual bleedingmedically known as menorrhagiaisnt always cause for alarm, but in some cases, the situation can be a red flag (pun totally intended) for underlying issues that may need attention. Here, OB/GYNs explain the most common causes for a heavy period, along with some thoughts on when to see your doctor about it.

Heavy periods fall on a spectrum. For some women, it can simply be defined as having a heavier flow than usual, causing you to soak through pads or tampons at a more rapid pace. Menorrhagia, on the other hand, is a serious diagnosis and can result in significant blood loss. Per the Mayo Clinic, some signs to watch out for include:

An overactive or underactive thyroid are two of the most common culprits for menstrual difficulties, according to Sherry Ross, M.D., an OB/GYN at Providence Saint Johns Health Center in Santa Monica, CA. Thats because your thyroid actually helps control your menstrual cycle, she says.

Although thyroid disease can cause your periods to stop for several months, it can also lead to heavy and irregular periods, Dr. Ross says. Its an underactive thyroid that tends to be the heavy period producer, because your ovaries are not making enough progesteronethe hormone that helps lower your flow.

Known as PCOS, this condition affects how the ovaries work, Dr. Ross says. Although it can cause loss of periods or irregular cycles, it can also lead to heavy flow due to hormonal shifts, and can be exacerbated by weight gain.

Excess estrogen leads to a thickened uterine lining that isnt shed by the production of progesterone. (Those with PCOS usually dont ovulate, which kicks off progesterone production.) That can lead to heavier flow as well as more clotting.

Almost always benign, fibroids are muscular tumors that grow in the wall of the uterus, and Dr. Ross says theyre common, especially as women age. Having a family history increases your risk, and so does being African American.

In addition to heavy bleeding, youre likely to experience pain along with some bloating and lower back pain, which is why the issue is often mistaken as a heavier-than-usual period. Fibroids are often detected in a regular pelvic exam, but your doc may suggest imaging like an ultrasound or MRI to get a better idea of where theyre located.

Hormone changes leading up to menopause creates a situation where periods become non-predictable, says G. Thomas Ruiz, M.D., OB/GYN lead at MemorialCare Orange Coast Medical Center in Fountain Valley, CA.

Instead of the standard 28-day length of time for a cyclewhich can vary between 21 to 35 days and still be considered normal, Dr. Ruiz notesa change in estrogen as the body prepares for menopause may mean the body is still creating a thicker uterine lining but not shedding it yet. A missed period or two during this time means that lining continues to increase until gravity does its part.

The lining starts to fall off from getting too thick and thats when youll see a heavy menstrual flow, often with significant clots, he says. Some of these patients can bleed for weeks like this, which is not good, because then theres an anemia risk.

In the first trimester, signs of a miscarriage can mimic a menstrual period, because there will be bleeding and clotting, says Dr. Ross. For some women, they may not have even known they were pregnant. According to Penn States Milton S. Hershey Medical Center, as many as 30% of women will experience this at least once, and causes can include chromosomal abnormalities, autoimmune disease, infections, and structural issues with the uterus, among other factors.

If you suddenly try to go from couch potato to triathlete, it can cause a hormonal imbalance as your body attempts to adjust, Dr. Ross says. Although amenorrhea can happen, which means you lose your period, your body could decide to swing in the other direction and go heavy instead.

This causes physical stress, which influences your periods, and that can happen over weeks and months, she notes. As you keep intensifying your training, your periods may become increasingly heavier, she says.

Again with the estrogen: Extreme weight gain can increase body fat, particularly in the abdominal region, which is where the majority of your estrogen is produced. Dr. Ross says that as estrogen increases, that can lead to thicker uterine lining and generally heavier periods. Women who have obesity also tend to experience periods that are longer than seven days and come with blood clots.

Significant weight loss can reverse this effect, she says. That causes a decrease in body fat and estrogen production, making your periods lighter.

Certain coagulopathies, known as bleeding disorders, like von Willebrands disease, platelet function defects, thrombocytopenia, and clotting factor deficiencies can also lead to a heavy flow. Among women with heavy menstrual bleeding, coagulopathies may be the cause in up to 24% of themespecially young women, says Carolyn Swenson, M.D., an assistant professor of obstetrics and gynecology at the University of Michigan.

The average woman with a bleeding disorder could first experience prolonged bleeding as young as six years old, but may not receive a diagnosis until 23, per the National Hemophilia Foundation. Other symptoms to look out for include excessive bleeding after an injury, prolonged nosebleeds, blood in urine or stool, and bruising easily.

Certainly, this is not the potential cause that should be your first thought during a heavy period, but it's a small possibility. Heavy bleeding is one of the biggest early signs of uterine, cervical, and endometrial cancer, especially if a woman has already been through menopause and no longer has periods.

But even for those who regularly have menstrual cycles on the heavier side, getting annual screenings is important to make sure cancers like these are caught early if they do develop.

Again, whats considered heavy varies by person, according to Lucille Russo, M.D., an OB/GYN at Northwestern Medicine Central DuPage Hospital in Illinois. For example, if youve had heavy periods all your life and been checked about it, that would be far less of a concern than if your periods suddenly became much heavier than usual.

1 out of 5 women deals with heavy periods, per the CDC.

Typically, I tell patients if they are soaking through a maxi pad or super tampon every hour for a few hours, they should call, says Dr. Russo. Also, if their periods are heavy and long, like lasting more than 10 days, or they are persistently bleeding between periods, they should contact their doctor.

Two other signs to make the call include seeing multiple clots that are bigger than 1-inch wide, and needing to us both pads and tampons at the same time, she adds.

Even if you dont have any of the underlying issues mentioned here, its worth speaking with your doctor about potential treatments, Dr. Russo says, because persistently heavy periods can often cause anemia, a condition where there arent enough healthy red blood cells to carry needed oxygen to your bodys tissues. That can lead to fatigue, weakness, dizziness, and rapid heartbeat with exercise.

Bottom line: In general, its likely you know when something seems wrong down thereget it checked to be safe.

Like what you just read? Youll love our magazine! Go here to subscribe. Dont miss a thing by downloading Apple News here and following Prevention. Oh, and were on Instagram too.

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Why Is My Period So Heavy? - 9 Causes of Heavy Menstrual Flow - Prevention.com

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Advanced Age Management offers Testosterone Replacement Therapy. This mens clinic is located near Cleveland, OH, and it gives men the perfect solution if they are feeling sluggish, low energy, gaining weight, or they have a decreased sex drive. Advanced Age Management says if youre over the age of 35, you could have low testosterone, and this is normal as you get older, but you will start to notice issues more and more as you age.

This mens clinic in Cleveland, OH, says it is due to a condition called Hypergonadism, yet, they want to reassure individuals who may be concerned and worried that their testosterone production level is low, that is why they are now offering testosterone replacement therapy in their clinic. If you are suffering from one of the issues mentioned above, definitely consider scheduling an appointment with your doctor and get your testosterone levels checked. Contact Advanced Age Management, and they will advise you on your next step and get you in for a free testosterone assessment.

At Advanced Age Management, their goal is to help men build up their testosterone levels by testing testosterone levels and creating a treatment plan to get the testosterone levels back to an appropriate level so that each individual does not have to suffer anymore and can carry on with their life. This is all done through the testosterone replacement therapy at their mens clinic.

It would be best if you got in touch with Dr. John Kocka at Advanced Age Management, a low testosterone expert who carries out a series of assessments and testosterone replacement therapy for men and women in and around Cleveland Ohio. According to Advanced Age Management, the cost of the testosterone replacement therapy varies from each patient to the next, as each person will require a different treatment plan. You can, however, schedule a free consultation and also review your financial information with Dr. John Kocka once you get in touch.

Advanced Age Management emphasizes that the therapy offered to men is only for those with testosterone deficiencies, which is why this mens clinic is the best to consult with if you have found out that you have low testosterone. If needed, Dr.Kocka can offer you a same-day consultation.

If you have been given the go-ahead for testosterone replacement therapy, Advanced Age Management assures you that there are many benefits of testosterone treatment. There is evidence to suggest the therapy can improve your cardiovascular health by removing cholesterol from your arteries, a common issue that many men suffer with as they get older.

The mens clinic in Cleveland, OH, assists men for other hormone treatments as well, such as DHEA, cortisol, thyroid, natural growth hormone, insulin, and more.

Contact Advanced Age Management today at (330) 439-6591 and schedule your free consultation with one of their low testosterone doctors. This mens clinic is offering you the chance to increase your testosterone levels and, in turn, improve your health and overall well-being. At Advanced Age Management, the doctors use injection therapy for men who need more testosterone production. You can read more about low testosterone and the testosterone replacement therapy on their website at https://www.lowtohio.com.

Source:https://thenewsfront.com/advanced-age-management-offer-testosterone-replacement-therapy/

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Advanced Age Management Offer Testosterone Replacement Therapy - The News Front

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Your brain has nerve cells called neurons that can multiply within certain areas of your brain. A big factor behind this is a growth hormone called brain-derived neurotrophic factor (BDNF). "BDNF is a protein produced by brain cells that is very important to the function and survival of brain cells," Lin explains. "We used to believe that we are born with a specific number of nerve cells in the brain, and once they die, they don't grow back. We now know that is not true."

Instead, your brain has the ability to regenerate and repair itself, and BDNF is "critical" in the process, Lin says. "Studies show curcumin can increase BDNF levels, and thus support brain healing and regeneration from injury and trauma," she says.* Cognitive decline is a form of inflammation of the brain tissues, and, given that curcumin manages inflammation, it may help protect people from developing cognitive decline, Lin says.*

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What Is Curcumin? Why This Anti-Inflammatory Active Is A Game-Changer - mindbodygreen.com

Recommendation and review posted by Bethany Smith

(PRESS RELEASE) CHICAGO Because women have higher rates of eye diseases and eye conditions than men, Prevent Blindness, the nations oldest non-profit eye health organization, has designated April as Womens Eye Health and Safety Month. The group provides free information to the public on various eye health topics, including vision issues, possible changes in vision during pregnancy, cosmetic safety and more.

Women have a higher prevalence of many of the major vision problems, including:

The National Eye Institute states that 26 percent more women aged 12 and older have uncorrected visual impairment due to refractive error compared with men aged 12 and older. And, 14 percent more women aged 40 and older have refractive errors compared with men aged 40 and older. Additionally, women are also more likely to have autoimmune conditions, which often come with visual side effects.

According to the American Academy of Ophthalmology, for women, fluctuating hormone levels of estrogen and progesterone can affect the eyes oil glands, which can lead to dryness. Estrogen can also make the cornea less stiff with more elasticity, which can affect how light travels into the eye. The dryness and the change in refraction can cause blurry vision and can also make wearing contact lenses difficult.

Pregnancy brings an increase in hormones that may cause changes in vision. Women with pre-existing eye conditions, like glaucoma, high blood pressure or diabetes, need to alert their eye doctor that they are pregnant (or planning to become pregnant).

Lastly, women often make the majority of their familys health care decisions and are often responsible as caregivers for the health care choices of their children, partners, spouse, and aging parents. It is important to remind women to make their own vision and eye health a priority to prevent unnecessary vision loss in the future.

Prevent Blindness recommends steps that should be taken to protect vision and eye health, including:

OCuSOFT Inc., a privately-held eye and skin care company dedicated to innovation in eyelid hygiene and ocular health, is partnering once again with Prevent Blindness in support of Aprils Womens Eye Health and Safety Month.

Today, obviously there are significant challenges in maintaining overall health, said Jeff Todd, president and CEO of Prevent Blindness. We want to remind women of all ages that there are many ways to protect the gift of sight today so that it can be enjoyed for many years to come.

For more information on womens eye health, including fact sheets on eye diseases and eye protection, please visithere or call (800) 331-2020. Prevent Blindness offers a free listing of financial assistance services in English and Spanish here.

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ClearVision Optical Remains Committed to Caring for Customers During COVID-19 - InvisionMag

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The illegal killing of this rare species of giraffe and her calf leaves a lone surviving male in the entire world. The death of the white giraffe, whos alabaster color is caused by leucism, a condition that only produces dark pigments on soft tissues, has left the community of Ijara, Kenya saddened.

Not only is this a long-term loss of research industries, but tourism will also take a hit.

This is a very sad day for the community of Ijara and Kenya as a whole, Mohammand Ahmednoor, manager of the Ishaqbini Hirola Community Conservancy, said. We are the only community in the world who are custodians of the white giraffe.Its killing is a blow to tremendous steps taken by the community to conserve rare and unique species, and a wake-up call for continued support to conservation efforts.

The Ishaqbini Hirola Community Conservancy where the giraffes lived is located in a vast, non fenced-in area within two villages.

The Hirola Conservation Program was formed to support conservation efforts and continued research of the giraffes after the female white giraffe was first spotted in the conservancy in 2017. But the female giraffe was first discovered in Kenya in March 2016 in Tanzania at the Tarangire National Park. She recently gave birth to two calves in August 2019.

While the poachers have yet to be identified, the Kenya Wildlife Society is investigating the killings.

Today, the female giraffes surviving male calf is the only remaining white giraffe in the world and, according to the Giraffe Conservation Foundation, the total population of giraffes living in Africa has decreased by 30% since their count in 1980s with an even more dramatic drop on other areas of the world.

This is a long-term loss given that genetics studies and research which were significant investment into the area by researchers has now gone to the drain, Ahmednoor said. Further to this the white giraffe was a big boost to tourism in the area.

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Unique female white giraffe and calf killed at hands of illegal poachers in Kenya - NationofChange

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A true story: 12 ships dock in the Italian port of Messina in 1347. The sailors on board are all either dead or very gravely ill, covered in the oozing, pus-filled black boils that gave the greatest pandemic of the Middle Ages its lasting moniker: the Black Death. This was the bubonic plague which was to wipe out a third of the population of Europe, or more than 20 million people, in less than a decade. How was social distancing practised then, almost 700 years ago, and how different is the situation today?

Lets begin by looking at a couple of historical coincidences concerning a world narrative of disease transmission and spread. In 2011, an international group of scientists published a paper in Nature that traced the genetic route of the Yersinia pestis, the bacterium that caused the bubonic plague in the Middle Ages. Their conclusion was that, then as now, the infection originated in China or nearby. The virus moved variously via the Silk Road and other land-trade routes, until sea trade brought it to the docks of Europe. Then, as now, the first major epicentre in Europe was Italy.

Then, as now, the recombinant transmission was animal to human: rats were the proximate cause then, as is the bat and/ or snake or, perhaps, the pangolin today. Travel routes were the pre-eminent vectors then, as now. Fear, apprehension and hope were the dominant emotions then, as now. What will befall us was the most common question and isolation, the most common preventive strategy.

Social symptomology

Medically, of course, there are huge differences: the infection in the case of the bubonic plague was caused by a bacterium, while it is a virus, the SARS-CoV-2, that precipitates the sometimes deadly symptoms of respiratory failure of COVID-19. For this reason, most comparisons made so far have been, appropriately enough, with the Spanish Flu of 1916-20. Yet, in terms of social symptomology, just as revealing could be the long-term impact of the Black Death, which hit Europe in times of relative peace, a century after the bloody fervour of the Crusades had peaked, just as the coronavirus has now gone global in peace time. It goes without saying that the economic impact of the plague pandemic was devastating, with starvation rampant and riots breaking out among the poor over sheer survival needs. It took almost a century then for global financial systems to recover.

To this day, the Great Plague remains stamped in world memory through the ubiquitous childrens rhyme Ringa-Ringa Roses, where the roses refer to the buboes on the bodies of victims and the innocuous ending all fall down indicates mass death. In contrast, the pandemics of the 20th and 21st centuries seem to have produced less major literature comparable, for instance, to Giovanni Boccaccios 14th century masterpiece, The Decameron, although Im willing to be corrected on this somewhat contentious claim.

Anyhow, it turns out that, almost immediately after the Black Death made its dramatic entry into Italy, Boccaccio, an established literary name, began to record the story of the isolationist measures that the elite of his time took to combat the crisis that had so suddenly overcome them. His descriptions of the distress are graphic. He writes of the multitude of corpses, of graveyards so full that vast trenches had to be dug wherein those who came after were laid by the hundred and being heaped up therein by layers, as goods are stowed aboard ship and of whole families thrown pell-mell into the streets each day. Conditions were so piteous, especially among the common people that:

...what more can be said save that so great was the cruelty of heaven (and in part, peradventure, that of men) that, between March and the following July, what with the virulence of that pestiferous sickness and the number of sick folk ill tended or forsaken in their need, through the fearfulness of those who were whole, it is believed for certain that upward of an hundred thousand human beings perished within the walls of the city of Florence, which, peradventure, before the advent of that death-dealing calamity, had not been accounted to hold so many

Another coincidence: the arc of the infection. Boccaccio specifically mentions March to July. Which is precisely where we are now with the coronavirus. Note, too, the reference to the teeming population. Here, too, Boccaccios observations are acute: fearfulness and the capacity for cruelty among the unaffected population; the high death toll in Florence where upward of a hundred thousand perished when no one even guessed the city held so many! Our cities from Milan to Mumbai have over a hundred times the medieval densities; on the other hand, the coronavirus is far less fatal than the plague but the bottomline is still lockdown.

The Decameron is the tale of 10 aristocrats, three men and, rather surprisingly, as many as seven women, young, well-bred and well-read, who barricade themselves in a villa in order to avoid the grim disease. Call it self-quarantine, if you will, and note its striking similarity to medical advice today. Social behaviour in the Middle Ages, it appears, was not that dissimilar to ours.

True, we know immeasurably more about medication, drugs, genetics and epidemiology today. Global cooperation of the sort that organisations like the WHO so swiftly call on would have been unthinkable then. After all, the Great Plague preceded Shakespeare and Galileo by more than 200 years. Modernity and its rationalist, scientific view of natural laws were barely a glimmer in the eyes of even great humanists such as Dante or Boccaccio; democratic norms unimaginable. But turn to human nature and its anxieties, and we find in The Decameron a universal text.

Tapestry of hope

What seems to have remained stubbornly unaltered down the centuries is the generic role that narratives an hundred stories or fables or parables or histories or whatever youd like to style them as Boccaccio says cheerfully play in coming to terms with the stress and trauma generated by the vengeful and devilish unknown. All that the characters in The Decameron do is hang out, tell stories and sing songs. Together, however, they cooperatively create a durable tapestry of hope.

Most modern interpretations of The Decameron, such as Pier Paolo Pasolinis famous 1971 film based on the book, have highlighted the bawdy concupiscence, the persistent lust and lechery on display in these stories. But it does not take a Freud to surmise that the obsession with the body in The Decameron at a time when the mutable human body is under terrifying siege makes psychological sense. These stories form immunity cordons, ringfencing the young people in their villa against desperation.

One of the striking features of The Decameron is that its cast is young and mostly female, with seven women (Boccaccio specifically mentions that their ages range from 18 to 28), and only three men. Why? Well, for one, it is clear throughout the text that Boccaccio thinks women are naturally more talkative and empathetic. Indeed, at the end of his book, he credits his female neighbour with complimenting his tongue as the best and sweetest in the world although some men are of the opinion that the same tongue is quite venomous.

More fundamentally, Boccaccios underlying philosophy seems to be that its not so much the sagacity of old age thats required in times of unprecedented crisis but a buoyant belief in the future such as comes naturally to the young. Today, wed say that the evolutionary will to survive and mate for the good of the species and to lead a good life, la dolce vita, is a primal instinct in our millennials, for example. In this respect, we could maintain that the coronavirus metaphorically follows the pattern set by Boccaccio: it spares the young. The young are certainly not invincible, as the Director of WHO has cautioned. But should they believe they are, the Director of the National Institute of Allergy and Infectious Diseases in the U.S., Dr. Antony Fauci, adds a wise, ethical footnote: the youth, he says, owe a debt to the rest of the species not to act irresponsibly and selfishly. It is here that The Decamerons message resonates.

Early humanism

Boccaccio offers us a microcosm of an early humanist world in the making. Though embedded in the local and inevitably mired in the prejudices of the time, its vision is astonishingly non-polarising, cosmopolitan and inclusive. For example, the trope of the Jew as the iconic other is prominent, but Boccaccios Jews are not in the least evil or targets of hate; instead, they are rational, likeable souls. Simultaneously, the Christian clergy are roundly condemned for their hypocrisy and venality, as are the pickmen who collect and dump the dead for money; Boccaccio calls them bloodsuckers. Today, such leeches could well include the callous rich and the politicians who seek to profit from calamity.

On display in The Decameron is the entire range of human folly: deceit, duplicity, dementia, violence. In one typically melodramatic story, a father cuts out his daughters lovers heart and offers it to her in a silver dish, whereupon she pours poison into the bloody bowl and consumes the gory potion, killing herself instantly. The point is that these harrowing instances of mans inhumanity to man only throw into luminous relief the innate goodness and generosity of ordinary folk. In this sense, Boccaccio intelligently recognises that nature, in essence, is non-hierarchical, even if culture chooses to privilege some over others.

If the adage is that death is the great leveller, infectious diseases surely come a close second. The Decameron begins with the pious declaration: A kindly thing it is to have compassion for the afflicted and then proceeds to examine, with no small degree of irony, the forms and genealogy of such empathy. It ends with admirable, self-reflexive humility: I confess that the things of this world have no stability and are still on the change and so it may have befallen on my tongue.

In other words, no judgement is infallible, and even ones most cherished beliefs are subject to correction. Part of this humility may be due to the demands of literary convention, but part seems to stem from genuine conviction. Boccaccio was deeply aware of the instability of his world and, consequently, his words.

Admit it as Boccaccio bravely did or not, we are perhaps just as uncertain in the 21st century during the times of the coronavirus. That is why reading The Decameron in the present corona hotspot of New York or in the possible future hotspot of New Delhi or anyplace anywhere, could be just the social prophylactic against depression and despair that we need in these troubled times.

The writer is critical theorist, writer, poet, and Professor Emerita at IIT Delhi. She was Distinguished Professor at Hunan University, China in 2019. Her books include Narrative Gravity: Conversation, Cognition, Culture.

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The strange and startling similarities between the Great Plague and COVID-19 - The Hindu

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BULL breeders across Australia have been quick to respond to latest government restrictions over gatherings of people, swinging quickly to online auctions in place of face-to-face bull sales.

There has been a sharp rise in online bidding in physical bull sales held over the past week, and an increase in the number of genetics sales scheduled for coming months which will now be online-only this year.

As COVID-19 unfolds, the online channel looks like providing an important function in livestock and seedstock sales to ensure an active marketplace and supply chain.

AuctionsPlus has this week fielded quite a few early inquiries from vendors for upcoming bull sales, operations manager Tom Rookyard told Beef Central this morning.

These had come from across Australia, as well as some from overseas, among stud breeders facing the same challenge around interacting with their buyers. Some were existing clients who in the past had held a physical sale, supported by interfaced AuctionsPlus online bidding, while others were studs new to online selling options.

Heres some recent examples of upcoming sales moving online this year due to COVID-19, and recent fixtures where online bidding has been strong:

The Limousin National Show & Sale committee issued a statement saying that based on current government recommendations and health guidelines, it was moving to an AuctionsPlus online-only format for its 2020 sale, which will remain on the same date of 1 May.

Due to government restrictions currently in place there will not be any events held in the sales host city of Wodonga. Photos and videos all the sale lots will be available online for prospective buyers. All cattle on offer will be independently vet-inspected and backed by the Limousin Assurance Program.

In another innovation, the sale committee has partnered with The Global Cattle Market group, which host the popular Champion of the World seedstock competition to bring an online judging platform for the sale this year, in lieu of the regular live judging program.

This will allow breeders and cattle enthusiasts across Australia and around the world to view and engage with the Limousin National, and help create more interest in the sale which in the past has been live-streamed to audiences, the committee said. The online judging program will commence mid-April with final champions to be announced during the week of the sale.

For more details on the event, contact Limousin Australia.

While the Australian Wagyu Associations WagyuEdge 2020 conference and tour has been called off, the Elite Wagyu Sale that normally forms a centrepiece for the conference will now proceed as an online-only event. The sale has been live for the past four years, with online bidding also offered, and has grown year-on-year to set some extraordinary seedstock industry price records in the past two years.

This years Elite Wagyu online-only sale will be conducted via AuctionsPlus on 30 April. The preliminary catalogue is now available online, offering 98 lots including registered females, bulls, embryo flushes and semen packages.

Kilburnies on-property Angus Female Dispersal on 27 March is now an AuctionsPlus Simultaneous Auction. All animals will be on sale simultaneously. Animals will be available for inspection by prior appointment from Noon on Tuesday until Friday 2pm. Click here for details.

Ascots Autumn bull sale on 1 April will go ahead, with precautions (see below) as usual on-property, North Toolburra near Warwick. Online bidding through AuctionsPlus is also available to buyers, with live video & audio, as well as bidding through buyers preferred agent.

As far as an indoor event (uninterrupted space of < 100 people) we have put in place measures so that social distancing can be achieved in our open sale shed, Ascots Jim Wedge said. We will only have two grandstands, with signs advising of 1.5m distancing. We will provide chairs on the western open side of the sale shed, spaced at 1.5m intervals, allowing buyers to spill outside and still be able to view the bulls in the ring. Well-placed spotters can pick up their bids, he said.

Seedstock sales held in Central Queensland this week have seen sharp rises in online bidding activity taking place.

More than 40 percent of bulls sold at Mondays Speckle Me Speckle Park bull sale at Gracemere sold to online bidders, using RLXs Stocklive platform.

The online purchases included the sales top-priced lot sold at $23,000 to the Birchmore family, bidding from Winton. In total, 31 bulls were sold for an average $7677 for a 100 percent clearance.

Nutrien Livestocks James Saunders said the sale reflected an outstanding result that was strengthened by access to online bidding technology.

It was an outstanding sale with support from right throughout Central Queensland and further west, and this was great to see considering some of the issues the world is dealing with at the moment, he said.

Stocklive worked extremely well and its very important we have that facility there, as the online bidders really strengthened the sale.

Almost 140 people viewed the Speckle Me sale on Stocklive with 11 active online bidders. The average for stock sold to remote bidders exceeded that of the general sale average at $9850.

Last Saturday, the Rocky All Stars Elite Brahman Female Sale held at Gracemere also interfaced with online bidding achieved a 100pc clearance and an average of $5381. Almost 250 logged in to view the sale on Stocklive with 14 lots secured online at a value of $58,500.

Robert Murray from Elders Stud Stock, Rockhampton, emphasised the importance of remote access to sales under current conditions.

The crowd was noticeably down because of the situation but we had tremendous support online, Mr Murray said.

Australias newest online livestock sales platform FarmGate Auctions has waived listing fees for livestock sellers, including private, stand-alone and stud stock sales, following the onset of the Coronavirus pandemic, in a bid to support the continuation of livestock trade in the coming months.

FarmGate Auctions co-founder and Gunnedah-based livestock agent Guy Gallen said coronavirus presented a whole raft of challenges for primary producers yet highlighted the need for reliable and remotely-accessible agtech solutions to help the livestock industry thrive in times of uncertainty.

With the new social distancing protocols in place in public areas which include saleyards, auction houses, rooms and places livestock producers and buyers are unsure of where to buy or sell their stock, Mr Gallen said.

We need to open every market opportunity we have and allow buyers and sellers to meet in ways they never have before. This means doing business remotely and online, which is why were waiving fees to encourage vendors and agents to consider this new platform for trade.

Established in 2017, FarmGate Auctions says it brings livestock producers closer to their customers, by using better technology and marketing opportunities as well as removing cost and red tape throughout the transaction.

Producers have faced their share of challenges in recent times with the drought and bushfires so its imperative now with a bit of a season behind us, that we help them capitalise on demand and get business back on track. New and creative technological solutions are a big part of that, Mr Gallen said.

After launching with cattle auctions in October 2019, FarmGate Auctions will hold its first sheep sale this Friday, with almost 2000 Merino sheep from the Australian Eastern Seaboard States.

Read more:
Bull breeders respond to COVID-19 with online selling strategies - Beef Central

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