Ethical questions are crucial, but they shouldnt stall the progress of this promising branch of medicine

In late November, Reuters reported a milestone in medical history: a gene therapy drug could go on sale in Germany next year, after winning the approval of European regulators two years ago. The drug, Glybera, by a Dutch firm called UniQure currently being scrutinised by Germanys federal joint committee would be the first commercial use of gene therapy in the Western world (China has had a gene therapy drug for a specific form of cancer in the market since 2004). This marks a potential turning point in an area of medicine that has been the subject of highs and lows over more than two decades of clinical trials.

Gene therapy which can involve a number of things, including replacing a malfunctioning gene or introducing a new gene with the ability to fight a disease has been in conceptual development for far longer. Its origins could be said to go back as early as the 1920s, well before the discovery of the structure of DNA, when a British scientist, Frederick Griffith, put forward what he described as the transforming principle; he successfully converted a non-virulent strain of bacteria into a virulent one, after injecting mice with both.

From the late 1960s, when the concept of gene therapy began to involve, it took several decades for the first clinical trial to take place in 1990. A young girl in the US with a genetic defect that had left her with a severely weakened immune system was successfully injected with her own white blood cells containing a corrected form of the malfunctioning gene.

However, the boost gene therapy got following that first successful trial was soon tarnished, in the view of the public, by a tragedy in 1999; an 18-year-old American boy, who had a mild version of a liver condition, which meant his body couldnt process ammonia, died during a gene therapy treatment. This was after a massive response by his immune system to the vector or carrier used to introduce the corrected gene.

The episode raised a number of issues including that of informed consent of those participating in clinical trials as well as the fact that identifying and correcting a defective gene was far from the only challenge facing gene therapy. Selecting the appropriate vector was also vital and not without risks.

Despite predictions that gene therapy would be lastingly damaged by the tragedy, research and trials continued with many promising results for a range of conditions ranging from immune system conditions to cancer, cystic fibrosis, Parkinsons disease and hemophilia.

The renewed confidence in gene therapy is highlighted by the fact that the worlds largest pharmaceutical companies have also entered the market (earlier this week, Pfizer announced collaboration with Spark Therapeutics, a Philadelphia based company on the development of a hemophilia B treatment).

Over 1,700 approved gene therapy trials have taken place in the past two decades, estimated an article on the history of gene therapy in Gene magazine last year with many successes and a few hits. Among the latter were trials conducted in France in 2001 on Severe Combined Immunodeficiency, a condition where the immune system is so crippled that in one case it required a boy to live in a germ-free bubble. Several infants involved in the trial subsequently developed leukemia, though other clinical trials for gene therapy since have been successful.

There have been some understandable public concerns about gene therapy and its impact on the one hand it offers that tantalising potential of curing some of the most lethal conditions while on the other, tampering with genetic makeup is something that has long conjured up fears in the public imagination of genetic engineering and exacerbating discrimination against those with disabilities and disease.

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Tommy #39;s Experience with Stem Cell Therapy
Tommy discusses living with debilitating back pain and choosing stem cell therapy followed by hyperbaric oxygen therapy to improve his quality of life. Learn more at http://beyondpills.com/,...

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A short tour of the p-medicine Custodix Anonymisation Tool
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Big Data in Healthcare: Hype and Hope on the Path to Personalized Medicine - 2014 DHC
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Newswise An innovative targeted payload immunotherapy that is being readied for a Phase 3 clinical trial (due to begin in the first half of 2015), received a favorable endorsement from Actinium Pharmaceuticals Scientific Advisory Board (SAB). The nod occurred after the members conducted its year-end meeting to review the progress of Iomab-B, a radiolabeled antibody being developed as a part of bone marrow transplant regimen initially in relapsed and refractory AML patients ages 55 and older.

The group met prior to the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco and was Chaired by John Pagel, MD PhD of the Fred Hutchinson Cancer Research Center and Swedish Cancer Institute in Seattle and included senior members from Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center and other leading institutions. The SABs goal is to further the development of Iomab-B as a myeloablative agent for older relapsed and refractory AML patients. If approved, Iomab-B should increase the number of patients eligible for curative bone marrow transplant (BMT, also known as HSCT) and improve clinical outcomes.

Richard Champlin MD, Chair of Stem Cell Transplantation and Cellular Therapy at MD Anderson Cancer Center, stated, We are impressed with progress in Iomab-B development and are looking forward to starting the trial. Iomab-B treatment would be an important new addition to our unfortunately very limited armamentarium for the most difficult-to-treat AML patients, and could potentially change the way refractory AML in older patients is treated.

As an international leader in the field of hematopoietic stem cell transplantation (HSCT), Dr. Champlin pioneered the use of donor transplants and lower doses of chemotherapy, reducing mortality rates along the way. Under his leadership, the MD Anderson HSCT program grew to become the largest in the world.

The Company updated the SAB on progress made in 2014, including refining and completing the Phase 3 protocol, progress in manufacturing centralization and scale-up, CRO engagement and the completion of other administrative items. Plans for 2015 were also reviewed, including assembly of the IND (Investigational New Drug) Application for submission to FDA early next year, clinical trial sites selection, preparation of ancillary materials and other items related to the upcoming pivotal trial. This study is planned as the final clinical trial prior to potential FDA clearance and approval.

Dr. Dragan Cicic, Chief Medical Officer of Actinium stated: "Actinium is committed to the ongoing development of Iomab-B with a multi-center Phase 3 pivotal trial due to begin in 2015. With the continued support and input from our world renowned scientific advisors, we are moving quickly to advance Iomab-B development. The SAB meeting further supported our belief that, if approved by FDA, Iomab-B could significantly change the treatment paradigm for elderly relapsed and refractory AML patients by providing a potentially curative pathway for majority of patients who today have a life expectancy of 5 or fewer months."

About AML Acute myeloid leukemia (AML) is an aggressive cancer of the blood and bone marrow. It is characterized by an uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014, most of them in adults. Patients over age 60 comprise the majority of those diagnosed with AML, with a median age of a patient diagnosed with AML being 67 years. Treatment approaches in this population are limited because a majority of these individuals are judged too frail and unable to tolerate standard induction chemotherapy or having forms of disease generally unresponsive to currently available drugs. Elderly, high risk patients ordinarily have a life expectancy of 5 or fewer months if treated with standard chemotherapy, and only about a third of them receive this treatment because of toxicity of and limited responses to the available therapy. The other two-thirds receive best supportive care, with 2 months survival, according to Oran and Weisdorf (Haematologica 2012; 1916-24).

About Iomab-B Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

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Irvine, California (PRWEB) December 08, 2014

The Ageless Derma skin care company has added a moisturizing product to their line that provides continuous hydration to skin throughout the day. The Swiss Apple Stem Cell Oil-Free Continuous Moisturizer uses rare Swiss apple stem cells in combination with other natural substances to aid in skins retention of moisture for a lessening of fine lines and a silky, more comfortable feeling.

The Swiss Apple Stem Cell Oil-Free Continuous Moisturizer contains stem cells from the exotic Malus Domestica, a rare apple from Switzerland known for its long shelf life and its ability to stay fresh without shriveling. This apple species had a flavor that consumers found too acidic, making farmers reluctant to grow it. The Malus Domestica, however, was discovered to have interesting scientific advantages due to its ability to live a long, healthy life without the usual shriveling that accompanies fruit as it ages. The same idea has been transferred to Ageless Dermas latest moisturizer with its incorporation of these stem cell extracts for a renewed and rejuvenated facial complexion. The stem cells help with not only apple longevity, but also with repairing human skin cells. This results in the ultimate reduction of fine lines and wrinkles with regular use.

Other ingredients are added to the Swiss Apple Stem Cell Oil-Free Continuous Moisturizer to make this moisturizer a workhorse of anti-aging and hydrating skin renewal. Ceramides and essential fatty acids account for maximum skin hydration and strengthening of the skin barrier function. Capric Triglycerides silken skin, glycerin keeps moisturization and hydration in balance, and Ceramides 3, 611, and 1 (all lipids) stop moisture from escaping and hold the skin barrier intact. Swiss Apple Stem Cell Oil-Free Continuous Moisturizer also has sodium hyaluronate to attract and keep moisture in. The hyaluronate also aids in blood microcirculation and the smoothing of wrinkles.

The developers at Ageless Derma Skin Care know they are making something extraordinary happen. Their line of physician-grade skin care products incorporates an important philosophy: supporting overall skin health by delivering the most cutting-edge biotechnology and pure, natural ingredients to all of the skin's layers. This attitude continues to resonate to this day with the companys founder, Dr. Farid Mostamand, who nearly ten years ago began his journey to deliver the best skin care alternatives for people who want to have healthy and beautiful looking skin at any age. About this latest Ageless Derma product, Dr. Mostamand says, The Swiss Apple Stem Cell Oil-Free Continuous Moisturizer is a multi-beneficial product that protects skin and works to smooth lines and wrinkles as it keeps moisture in, working throughout the entire day. Without the correct distribution of moisture, skin becomes dry and susceptible to wrinkling. This product is oil-free and can be used for any skin type.

Ageless Derma products are formulated in FDA-approved Labs. All ingredients are inspired by nature and enhanced by science. Ageless Derma products do not contain parabens or any other harsh additives, and they are never tested on animals. The company has developed five unique lines of products to address any skin type or condition.

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Software billionaire Paul Allen says he's committing $100 million to create a new institute in Seattle focusing on the mechanics of human cell biology.

The Allen Institute for Cell Science's first project, the Allen Cell Observatory, will focus on creating computational models for the kinds of induced pluripotent stem cells, or IPS cells, that have the ability to turn into heart muscle cells or the epithelial cells that form the inner linings of organs as well as skin.

Such cells hold promise for facilitating research into how cells become diseased, and potentially for growing replacement tissues.

"Cells are the fundamental units of life, with every disease we know of affecting particular types of cells," Allen said in a news release. "Scientists have learned a great deal about many of the 50 trillion cells in our bodies over the last decades, but creating a comprehensive, predictive model of the cell will require a different approach."

The Allen Cell Observatory's goal is to produce a dynamic, visual database and animated models of cell parts in action. Such models could shed light on the processes by which genetic information is translated into cellular functions, and reveal what goes wrong in a diseased cell. That, in turn, could help researchers predict which therapies will work best to counter diseases, or perhaps head off the disease in the first place.

Allen's latest philanthropic venture was unveiled Monday at the American Society for Cell Biology's annual meeting in Philadelphia. It follows up on plans that the co-founder of Microsoft has had in mind for years.

"It's the right time to start a big initiative in cell biology: understanding how cells work, understanding the detailed things that happen inside cells, which is behind cancer and Alzheimer's and all those things," Allen told NBC News last year.

Software billionaire Paul Allen's latest philanthropic project is a $100 million commitment to create the Allen Institute for Cell Science.

Paul Allen's net worth is estimated at more than $17 billion. Over the past 15 years, he has contributed hundreds of millions of dollars to scientific projects including the Allen Telescope Array, the Allen Institute for Brain Science and the Allen Institute for Artificial Intelligence. Last month, he said he would contribute $100 million to the global fight against the Ebola virus. (Allen also owns somewhat less-scientific ventures, such as the Seattle Seahawks and the Portland Trail Blazers.)

The cell science institute will be housed in the seven-story Allen Institute headquarters building that is currently under construction in Seattle's South Lake Union neighborhood. The building is scheduled for completion in the fall of 2015, and will also house the Allen Brain Institute.

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SEATTLE, Dec. 9 (UPI) -- Microsoft billionaire Paul Allen donated $100 million to study the human cell in an effort to better understand human building blocks and their diseases.

The money will specifically go to the Seattle-based Allen Institute for Cell Science. Their first project will be creating computational models of induced pluripotent stem cells, or IPS cells, that can transform into epithelial cells that form the inner linings of organs as well as skin. This project, called the Allen Cell Observatory, is intended to find how these cells can be diseased and how to possibly form replacement tissue.

"Cells are the fundamental units of life, with every disease we know of affecting particular types of cells," Allen said in a statement. "Scientists have learned a great deal about many of the 50 trillion cells in our bodies over the last decades, but creating a comprehensive, predictive model of the cell will require a different approach."

About 90 percent of cancers are related to epithelial cells. Cancer is caused by a mutation in cells that causes cells to replicate uncontrollably without dying as a healthy cell would. Studying the epithelial cells is potentially a way to see that process in a different light and understand the root cause, thereby putting scientists one step closer to finding a cure.

"If you look at cancer, there are a tremendous number of genes turned on or off or mutated. This is also true for autism. What we don't know is which ones are important and which ones are not. The important ones are the ones that actually change how the cell grows, and once we have a better understanding of how this works we'll have a much better idea of which potential targets for new drugs," said Rick Horwitz, executive director of the institute.

Horwitz said the research and observations of the project will be made publicly available online in an effort to "empower research by our colleagues around the world."

"The cell is so complex, there is no one that I know ... who actually could do this by themselves," he said.

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Google has spent the past decade-and-a-half perfecting the science of recognizing patterns in the chaos of information on the web. Now its applying that expertise to searching for clues to the genetic causes of autism in the vast sea of data contained in the human genome.

On Tuesday, autism advocacy group Autism Speaks said it was partnering with Google to sequence the genomes of 10,000 people on the autism spectrum along with their family members. Google will host and index the data for qualified researchers to sift as they hunt for variations in DNA that could hint at autisms genetic origins.

We believe that the clues to understanding autism lie in that genome, Rob Ring, Autism Speaks chief science officer, told WIRED. Wed like to leverage the same kind of technology and approach to searching the internet every day to search into the genome for these missing answers.

The project will make use of Google Genomics, a tool launched by the company several months ago with little fanfare on Googles Cloud Platform. As sequencing the human genome becomes ever-faster and cheaperRing says it can be done for about $2,500, compared to nearly $3 billion for the Human Genome Projectthe volume of genetic data generated by researchers has grown astronomically. By allowing researchers to dump that data onto its servers, Google gets to show off and improve the capabilities of its cloud while providing a potentially important service.

David Glazer, director of engineering for Google Genomics and formerly director of engineering for Google Plus, says that instead of searching for keywords, researchers can search for particular regions and sequences along genomes and find sections with common variations. And because a single human genome can run to 100 gigabytes, having the data in a central location makes remote collaboration among researchers easier. Youre a lot more efficient than shipping around station wagons full of hard drives, Glazer says.

Liz Feld, president of Autism Speaks, says she hopes that intense genetic analysis will help researchers tailor more individualized treatments, much as genomic analysis has led to a more refined understanding of different subtypes of cancer. What matters most to us is that this research is going to allow us to uncover and understand the various forms of autism, Feld says.

The autism genomics project is hardly the first Google foray into health and medicine. The company has targeted everything from Parkinsons disease to cancer, though genomics research is especially well suited to Googles technological strengths. In recent years, researchers have come to see biology as ripe for understanding by way of computing as much as chemistry. After all, nature has spent billions of years perfecting DNA as its most efficient way for storing and transferring information.

Autism Speaks has itself been collected genomic data for more than a decade, Ring says. Now he says he believes they have the tools to do something valuable with it: We realized that some of our biggest biology problems were really big data problems.

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Futuristic Genetics Lab Environment
Check out more of my work at: http://kreichweinart.blogspot.com/

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genetics state of mind

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CARTA: Domestication Evolution-Anna Kukekova: Fox Domestication Genetics of Complex Behaviors
Visit: http://www.uctv.tv) Anna Kukekova (Univ of Illinois at Urbana-Champaign) discusses the genetics-centered view of domestication that was supported by the experimental selection of farm-bred...

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New Genetics The Future, The Now
Larry Wang Kaitlyn Dayton Greg Specht Madison Rosen Song used: Justin Bieber - All Around The World.

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Treatment allows scientists to remodel eye cells into light receptors It uses a gene that alters eye cells and an injected chemical 'photoswitch' The photoswitch works with the gene to turn light sensitivity on in cell Blind rescue dogs could see flashing lights after treatment, study says Blind mice became as good at navigating a water maze as normal mice The treatment could be used to help people with retinitis pigmentosa -an inherited condition resulting in progressive loss of sight

By Ellie Zolfagharifard for MailOnline and Press Association

Published: 08:31 EST, 9 December 2014 | Updated: 10:03 EST, 9 December 2014

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A radical form of gene therapy that remodels eye cells into light receptors has allowed scientists to partially restore the sight of animals with inherited blindness.

Scientists say the same technique could one day be used to treat people with retinitis pigmentosa - an inherited condition resulting in progressive loss of sight.

In early tests on blind rescue dogs with a similar condition, showed they could restore sufficient light sensitivity for the animals to distinguish between flashing and non-flashing lights.

In normal mice (left), stimulating the retina produced a variety of responses, as shown by the colours. A similar response was achieved using the radical new therapy in blind mice - as shown in the colourful centre square. The right image reveals the blind mice who had the therapy in different retinal ganglion cells. The results in these types of cells were less dramatic

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It's been an absolute banner year so far for gene therapy developer bluebird bio Inc. (BLUE: Quote) whose share price has surged more than 130 percent year-to-date.

Before we discuss what's making news at bluebird bio today, here's what "gene therapy" means in simple terms.

Gene therapy is a technique that uses genes to treat or prevent diseases caused by defective or missing genes. This approach helps to address the underlying cause of the disease, rather than offering solutions that focus only on the disease symptoms. Though not a new field, gene therapy is still considered experimental as it faces many technical challenges and concerns regarding its safety.

Did you know the world's first commercial gene therapy was approved in China?

Gendicine, developed by SiBiono GeneTech Co., Ltd., for head and neck squamous cell carcinoma was launched in China in 2004. A year later, another gene therapy product - Oncorine for the treatment of head and neck cancer - was launched, in China, by Shanghai Sunway Biotech Co. Ltd.

Russia launched its first gene therapy drug, Neovasculgen, to treat Peripheral Arterial Disease on the market in 2011.

In the Western world too, there is one approved gene therapy - Glybera - developed by uniQure N.V. (QURE) for adult patients diagnosed with familial lipoprotein lipase deficiency. Approved by the European Commission in November of 2012, Glybera is expected to be launched in Europe this quarter or in Q1, 2015. It is currently not approved for use outside of the European Union.

Now, coming back to today's topic under consideration - bluebird bio - its stock was up more than 43% in Monday's extended trading (Dec.8, 2014), following promising results of its investigational gene therapy LentiGlobin BB305 in patients with beta-thalassemia major, a severe form of beta-thalassemia. The results were presented at the Annual Meeting of the American Society of Hematology yesterday.

Beta thalassemia is an inherited blood disease that reduces the production of hemoglobin. Abnormalities in a gene that is responsible for the production of beta globin (beta-T87Q-globin) causes sickle-cell disease and beta thalassemia. Depending on the severity of symptoms, beta thalassemia is classified as thalassemia major (also known as Cooley's anemia) and thalassemia intermedia.

Beta globin is one of the proteins that make up hemoglobin. Treating beta-thalassemia includes frequent and lifelong blood transfusions, which deliver red blood cells to the body to correct the anemia.

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Leila Morris MD - Personalized Medicine

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Scientists break early barrier to treating spinal cord injuries
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