StemCell Therapy

SAN DIEGO, Oct. 26, 2012 /PRNewswire/ --ViaCyte, Inc., a leading regenerative medicine company developing a transformative cell therapy for treatment of diabetes, announced today that it has received a $10.1 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM).

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ViaCyte's innovative stem cell-based therapy for diabetes has been supported by several previous rounds of funding from CIRM, including a $20 million Disease Team Award in 2009. This support has directly aided the development of VC-01, a regenerative medicine, combination product consisting of pancreatic beta cell progenitors encapsulated in a durable macroencapsulation device. When implanted under the skin of a patient with diabetes, VC-01 is expected to produce insulin and other factors which should safely and effectively control their disease. In its review of ViaCyte's application, CIRM's Grants Working Group characterized the Company's proposed therapy as the "holy grail" of diabetes treatments.

ViaCyte recently held a successful Pre-IND meeting with the United States Food and Drug Administration (FDA) and is on track to file an Investigational New Drug (IND) Application and initiate clinical evaluation of VC-01 in 2014. The Strategic Partnership Award from CIRM will be used to support these efforts, reflecting CIRM's commitment to following promising science through the progressive stages of product development.

"We are very grateful for the assistance that we are receiving from CIRM to advance our promising technology", stated Dr. Paul Laikind, President and CEO of ViaCyte. "Today's grant allows us to continue our efforts on behalf of the California taxpayers to break new ground with our stem cell-based product that has the potential to essentially cure patients with type 1 diabetes and provide a powerful new treatment for those with type 2 disease as well."

Approval of the award came from CIRM's governing board, the Independent Citizens Oversight Committee (ICOC), with advisement from the Scientific and Medical Research Funding Working Group. "ViaCyte has made good on their initial Disease Team award from CIRM, including a successful Pre-IND FDA meeting, and as a consequence, CIRM and the ICOC are glad to have the opportunity to continue funding ViaCyte's efforts to provide this product to patients with diabetes in California and the rest of the world," said Dr. Alan Trounson, President of CIRM.

About ViaCyte

ViaCyte is a private company focused on developing a novel cell therapy for the treatment of diabetes. The Company's technology is based on the production of pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin and other regulatory factors in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without risk of hypoglycemia and other diabetes-related complications.

ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.

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ViaCyte Receives $10.1 Million Strategic Partnership Award from CIRM to Continue Development of Diabetes Therapy

San Diego, CA/PRNewswire/ - ViaCyte, Inc., a leading regenerative medicine company developing a transformative cell therapy for treatment of diabetes, announced today that it has received a$10.1 millionStrategic Partnership Award from the California Institute for Regenerative Medicine (CIRM).

ViaCyte's innovative stem cell-based therapy for diabetes has been supported by several previous rounds of funding from CIRM, including a$20 millionDisease Team Award in 2009. This support has directly aided the development of VC-01, a regenerative medicine, combination product consisting of pancreatic beta cell progenitors encapsulated in a durable macroencapsulation device. When implanted under the skin of a patient with diabetes, VC-01 is expected to produce insulin and other factors which should safely and effectively control their disease. In its review of ViaCyte's application, CIRM's Grants Working Group characterized the Company's proposed therapy as the "holy grail" of diabetes treatments.

ViaCyte recently held a successful Pre-IND meeting with the United States Food and Drug Administration (FDA) and is on track to file an Investigational New Drug (IND) Application and initiate clinical evaluation of VC-01 in 2014. The Strategic Partnership Award from CIRM will be used to support these efforts, reflecting CIRM's commitment to following promising science through the progressive stages of product development.

"We are very grateful for the assistance that we are receiving from CIRM to advance our promising technology", stated Dr.Paul Laikind, President and CEO of ViaCyte. "Today's grant allows us to continue our efforts on behalf of theCaliforniataxpayers to break new ground with our stem cell-based product that has the potential to essentially cure patients with type 1 diabetes and provide a powerful new treatment for those with type 2 disease as well."

Approval of the award came from CIRM's governing board, the Independent Citizens Oversight Committee (ICOC), with advisement from the Scientific and Medical Research Funding Working Group. "ViaCyte has made good on their initial Disease Team award from CIRM, including a successful Pre-IND FDA meeting, and as a consequence, CIRM and the ICOC are glad to have the opportunity to continue funding ViaCyte's efforts to provide this product to patients with diabetes inCaliforniaand the rest of the world," said Dr.Alan Trounson, President of CIRM.

About ViaCyte

ViaCyte is a private company focused on developing a novel cell therapy for the treatment of diabetes. The Company's technology is based on the production of pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin and other regulatory factors in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without risk of hypoglycemia and other diabetes-related complications.

ViaCyte is headquartered inSan Diego, Californiawith additional operations inAthens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.

This news release may contain forward-looking statements made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995.

About CIRM

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ViaCyte Receives $10.1M Strategic Partnership Award From CIRM To Continue Development Of Diabetes Therapy

TORONTO, ONTARIO--(Marketwire - Oct 29, 2012) - Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("the Company"), a life sciences development company for stem cell-based medicines, today reported its admission to the Centre for Commercialization of Regenerative Medicine''s (CCRM) industry consortium.

"We are the only public Canadian company to be part of CCRM''s twenty-member consortium of international leaders in the regenerative medicine arena, a consortium designed to bridge business and scientific expertise to translate stem cell-based and regenerative medicine discoveries into commercial products and therapies," said David Allan, Executive Chairman of Stem Cell Therapeutics Corp. "Participating in this consortium links us to one of the key hubs in Canada for the commercialization of this country''s extraordinary output in stem cell-based science."

The corporate objectives for repositioning the Company include the now-announced involvement with CCRM, the identification and acquisition of additional technologies that will serve to attract capital to revitalize our organization, and striving to extract value from the important patented approaches for the stimulation of endogenous stem cells from Dr. Sam Weiss on which this Company was founded. Stem Cell is pleased to announce this involvement with CCRM as well as the receipt of US$175,000 of a $250,000 arrangement with NeuroNova AB, a Swedish private company developing new therapeutics for ALS and Parkinson''s. The full payment will settle a patent interference case initiated by the United States Patent and Trademark Office under which Stem Cell has withdrawn certain pending and issued patents to treat Parkinson''s disease.

The Company further advises that two additional patient have now been enrolled in its ongoing trial in Traumatic Brain Injury at Calgary''s Foothills Hospital. These patients bring the trial to the midpoint of enrollment, restoring the prospect of the trial to meet the original timelines anticipated by the investigators after enduring a slow initial recruitment period. The Company continues to concentrate its efforts on the conclusion of its remaining objectives.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) is a Canadian commercialization receptor company in the business of developing stem cell-based therapeutics through partnerships with research institutions or technology transfer organizations. The Company''s corporate objectives include the analysis and acquisition of additional stem cell-related development opportunities and securing capital for the advancement of the licensed or acquired products. SCT has extensive expertise and experience in the stem cell biotechnology sector based on the intellectual property of Dr. Samuel Weiss in stem cell research. SCT proposes to build upon this existing pipeline of stem cell technologies by acquiring new early-stage clinical or late-stage preclinical candidates. SCT''s Traumatic Brain Injury product, NTx-428, is currently in a Phase II clinical trial. For more information, visit: http://www.stemcellthera.com

Caution Regarding Forward-Looking Information:

Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, the "forward-looking statements"). These forward-looking statements relate to, among other things, SCT''s objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These statements reflect management''s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: uncertainties and risks related to, the availability of capital, changes in capital markets, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, unproven markets for technologies in development, the cost and supply of raw materials, management of growth, effects of payers'''' willingness to pay for products, risks related to regulatory matters and risks related to intellectual property matters. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" contained in SCT''s 2010 annual information form. SCT cautions that the foregoing list of important factors that may affect future results is not exhaustive.

When relying on SCT''s forward-looking statements to make decisions with respect to SCT, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Such forward-looking statements are based on a number of estimates and assumptions which may prove to be incorrect, including, but not limited to, assumptions regarding the availability of financing for research and development companies in addition to general business and economic conditions. These risks and uncertainties should be considered carefully and investors and others should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, SCT cannot provide assurance that actual results will be consistent with these forward-looking statements. SCT undertakes no obligation to update or revise any forward-looking statement.

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Stem Cell Therapeutics Announces Admission to Centre for Commercialization of Regenerative Medicine (CCRM) Consortium

TORONTO, ONTARIO--(Marketwire - Oct 29, 2012) - The collaborative network created by the Centre for Commercialization of Regenerative Medicine (CCRM) has been strengthened with the addition of Stem Cell Therapeutics Corp. to its 20-member industry consortium.

"I am pleased to welcome Stem Cell Therapeutics Corp. to the industry consortium," says Dr. Michael May, CEO of CCRM. "Since our Centre mobilizes business and scientific expertise to translate regenerative medicine (RM) and stem cell-based medical discoveries into commercial products and therapies, the industry consortium provides critical expertise, experience and market-pull information for the development of innovative RM technologies. We are delighted to have them on board."

CCRM is working with its industry consortium to address real-life bottlenecks in their RM and stem cell-based product pipelines. The companies in the industry consortium represent the key sectors of the industry: therapeutics, devices, reagents, and cells as tools.

"Being included in CCRM''s industry consortium is a step in the repositioning of our company - an aim described in our corporate objectives - to participate along with the other 20 Canadian, American and international companies," says David Allan, Executive Chairman of Stem Cell Therapeutics Corp. "The concept of CCRM as a hub for the commercialization of Canada''s extraordinary commitment to stem cell research, and its provision of facilities and infrastructure, is outstanding.

"As Canada''s only public company dedicated to the development of stem cell therapeutics from academic research, we hope to become one of CCRM''s commercialization partners of choice for the novel work ongoing at so many of Canada''s internationally recognized academic centres."

To-date, CCRM has launched its first industry project with EMD Millipore and created an innovation fund with Pfizer Canada. CCRM has built three core development platforms: reprogramming and engineering; cell manufacturing; and, biomaterials and devices to carry out projects commissioned by academia and industry. CCRM has a fully resourced, 6,000 square foot development facility where all development work takes place.

Please visit http://www.ccrm.ca to see a complete list of CCRM''s industry consortium members.

About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada''s Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto''s Discovery District on June 14, 2011.

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Canadian Regenerative Medicine Community Growing Stronger

Timothy J. Triche, MD PhD DBRM Retreat 2012 Genomics and Stem Cell Research
Non Coding RNA Functional RNA Transcripts in Cancer and Development Professor of Pathology, Cancer Biology, Pediatrics Keck School of Medicine of the University of Southern California Director, Center for Personalized Medicine at Children #39;s Hospital Los AngelesFrom:Clarence WigfallViews:6 0ratingsTime:17:49More inScience Technology

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Timothy J. Triche, MD PhD DBRM Retreat 2012 Genomics and Stem Cell Research - Video

A research team at the Yale School of Medicine has found a way to save platelets and white blood cells from the adverse effects of chemotherapy.

Led by School of Medicine genetics professor Jun Lu, the team conducted its research at the Yale Stem Cell Center over the past three years. By manipulating a microRNA molecule called miR-150, researchers were able to increase proliferation of white blood cells and platelets in mice, thus strengthening their immune systems, Lu said.

The human blood system is characterized by a rapid turnover of blood cells and platelets, Lu said. During chemotherapy, these cells have a shorter life span because they are being attacked by the drugs. The human body has not evolved to respond efficiently to chemotherapy, and as a result does not produce enough blood cells and platelets, leading to a compromised immune system.

Typically, miR-150 acts like a brake in a car, preventing white blood cells from overproliferation, said study contributor Prem Reddy of The Scripps Research Institute. The microRNA controls cell production by regulating the activity of the Myb gene, which influences the proliferation of white blood cells and platelets. When uncontrolled, the Myb gene can cause cancer by excessive production of these cells, Reddy said. High miR-150 levels lead to the production of fewer cells, he added.

While normal regulation will not harm people with healthy immune systems, these effects can be damaging to chemotherapy patients.

In a normal adult, approximately 10 billion white blood cells must be generated every day to compensate for daily loss, Lu said. For patients undergoing chemotherapy, which kills both cancerous and noncancerous cells, the necessary rate of generation is even higher. If miR-150 is suppressed and Myb levels are allowed to increase, enough cells can be generated to prevent the immune system from being compromised, Reddy said.

Massachusetts Institute of Technology biology professor Phil Sharp, a 1993 recipient of the Nobel Prize in physiology or medicine, said he considers this research interesting and novel. Although there are growth factor therapies that regenerate a patients immune system, this isolation and targeting of microRNA has not been done in previous studies, he said.

Before the studys findings are applied in a patient setting, however, Lus team will have to replicate these results in humans. They will then have to find or create drugs that will help suppress miR-150 and determine ways to deliver these drugs to cells of interest in the body, Lu said. After these steps, they will be able to conduct clinical trials.

If the drug the team finds is already approved by the United States Food and Drug Administration, Lu said, the clinical trial phase may be shorter, as its side effects will already be known.

Sharp said that while it may take years before this technique is used in humans, Lus findings show promise.

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Technique shields immune system from chemo effects

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, announced that the European Commission has granted conditional marketing authorization for ADCETRIS (brentuximab vedotin). ADCETRIS was approved for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). As a result, under the collaboration Seattle Genetics will receive two milestone payments from Millennium, one for each indication, totaling $25 million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

The approval of ADCETRIS by the European Commission marks a significant milestone for the product and for the many relapsed or refractory HL and systemic ALCL patients in need of effective new treatment options in Europe, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. In addition to the U.S. and EU approvals of ADCETRIS, we are making regulatory progress for approval in Canada while Millennium and Takeda are pursuing regulatory approvals in other countries. Complementing these regulatory activities is a robust ADCETRIS clinical development program to support our goal of establishing it as the foundation of therapy for CD30-positive malignancies.

The conditional marketing authorization for ADCETRIS is valid in the 27 member states of the European Union (EU) as well as Norway, Liechtenstein and Iceland. Similar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products that fulfill an unmet medical need with a positive benefit/risk assessmentand whose immediate availability would result in a significant public health benefit. Conditional marketing authorization by the European Commission includes obligations to provide additional clinical data at a later stage to confirm the positive benefit-risk assessment. The ADCETRIS Marketing Authorization Application was filed by Takeda Global Research & Development Centre (Europe) to the European Medicines Agency.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2011 for relapsed HL and sALCL.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs. Seattle Genetics is entitled to royalties based on a percentage of Millennium's net sales in its territory at rates that range from the mid-teens to the mid-twenties based on sales volume, subject to offsets for royalties paid by Millennium to third parties.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

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Seattle Genetics Announces ADCETRIS® Receives European Commission Conditional Marketing Authorization

Bruce Lipton - New Health Paradigm
upliftfestival.com UPLIFT 2012 is thrilled to bring Bruce Lipton to Byron Bay! Bruce H. Lipton, PhD is an internationally recognized leader in bridging science and spirit. Stem cell biologist, bestselling author of The Biology of Belief and recipient of the 2009 Goi Peace Award, he has been a guest speaker on hundreds of TV and radio shows, as well as keynote presenter for national and international conferences. Dr. Lipton began his scientific career as a cell biologist. He received his Ph.D. Degree from the University of Virginia at Charlottesville before joining the Department of Anatomy at the University of Wisconsin #39;s School of Medicine in 1973. Dr. Lipton #39;s research on muscular dystrophy, studies employing cloned human stem cells, focused upon the molecular mechanisms controlling cell behavior. An experimental tissue transplantation technique developed by Dr. Lipton and colleague Dr. Ed Schultz and published in the journal Science was subsequently employed as a novel form of human genetic engineering. In 1982, Dr. Lipton began examining the principles of quantum physics and how they might be integrated into his understanding of the cell #39;s information processing systems. He produced breakthrough studies on the cell membrane, which revealed that this outer layer of the cell was an organic homologue of a computer chip, the cell #39;s equivalent of a brain. His research at Stanford University #39;s School of Medicine, between 1987 and 1992, revealed that the environment ...From:UPLIFTfestivalTVViews:35 0ratingsTime:02:48More inPeople Blogs

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Bruce Lipton - New Health Paradigm - Video

26-Medical BiotechnologySG Part Ic. Animal and Human Cloning and Genetic Engineering.mov
Some of the same techniques described for stem cell research, have been extended and applied to animal cloning, creating part of the controversies surrounding both topics. What is cloning? Cloning an organism (as a totally different process distinguished from cloning a gene) is a process whereby all members are directly descended, asexually, from a single organism by......various ways, as we show in this section, and this demonstrates that all the information required for an organism and its development are in the a single cell. many animals have now been cloned, including, sheep (Dolly), cattle, pigs, mice, rats, fish, dogs, cats, horses, mules, and more recently monkeys. Can humans be cloned? Probably.From:Albert KauschViews:8 0ratingsTime:25:57More inEducation

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26-Medical BiotechnologySG Part Ic. Animal and Human Cloning and Genetic Engineering.mov - Video

(301) 337-2100 "Gene Therapy Rockville, 20850" "Cell therapy Rockville, 20850"
http://www.AmericanGeneTechnologies.com American Gene Technologies International Inc. (AGTII) is developing bio-safe, high efficiency lentivirus therapies to treat cancer and other chronic human diseases. AGTII was founded in 2007 to develop bio-safe, high-efficiency, multi-gene vectors for human gene delivery in-vivo. AGTII #39;s products incorporate a novel, proprietary technology for the clinical application of gene expression technology in cancer therapy, autosomal disorders, stem cell treatment, and cosmetic applications. In vivo studies completed at the University of Maryland have demonstrated the efficacy of AGTII #39;s prototype prostate cancer therapeutic by eliminating Human Prostate Cancer tumors in mouse hosts. The active treatment group showed complete resolution of disease without harm to healthy tissue - even in large, late-stage tumors. AGTII also has prototype therapeutics in testing for Pancreatic Cancer. These prototypes have demonstrated efficacy in In vitro testing, as well. Additional designs for therapeutics addressing other cancers are in the design phase. AGTII #39;s vision is to use its technology to enable the one hundred billion dollar genetic drug market. CONTACT US! American Gene Technologies International Inc. Maryland Technology Development Center 9700 Great Seneca Highway Rockville, MD 20850 Phone: (301) 337-2100 Fax: (301) 337-2101 Email: info@agtii.com ----------------------------------------------------- Produced by: Create A Social Buzz SEO Social ...From:CreateAsocialBuzzViews:16 0ratingsTime:01:38More inScience Technology

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(301) 337-2100 "Gene Therapy Rockville, 20850" "Cell therapy Rockville, 20850" - Video

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

bluebird bio, a leader in the development of innovative gene therapies for severe genetic disorders, announced today that the California Institute for Regenerative Medicine (CIRM) has approved an award to the company for $9.3 million for the first round of its new Strategic Partnership Awards initiative. The award is to support a Phase 1/2 study to evaluate the safety and efficacy of LentiGlobin, the companys development-stage program for the treatment of beta-thalassemia, which will be initiated in the United States in 2013.

We are very encouraged by the clinical data generated to date demonstrating the potential of LentiGlobin as a one-time transformative gene therapy for patients with beta-thalassemia, said David Davidson, M.D., chief medical officer, bluebird bio. bluebird bio has made significant advances in lentiviral vector design, transduction efficiency, and in our manufacturing process, enabling the production of gene-modified products that can be scaled and deployed for many different clinical indications. We are delighted that CIRM has chosen to recognize the importance of this innovative approach for the treatment of one of the most commonly inherited blood disorders, and we are excited to work with CIRM to continue the development of LentiGlobin in the U.S.

bluebird bios LentiGlobin product introduces a fully functional human beta-globin gene into the patient's own hematopoietic stem cells. These corrected stem cells ultimately produce fully functioning red blood cells. bluebird bio is currently conducting a Phase 1/2 trial examining the feasibility, safety and efficacy of LentiGlobin in the treatment of beta-thalassemia and sickle cell disease. Results of the first patient were reported in Nature in 2010, showing dramatic results, including stable expression of functional beta-globin resulting in transfusion independence which now extends for greater than four years following a single treatment.

This CIRM award is among the first awards under the agencys Strategic Partnership Awards initiative, which is designed to engage more effectively with industry and to increase outside investment in CIRM-funded stem cell research. The funding awards were made at the October 25, 2012 meeting of the stem cell agencys governing board, the Independent Citizens Oversight Committee (ICOC).

About CIRM

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About bluebird bio

bluebird bio is developing innovative gene therapies for severe genetic disorders. At the heart of bluebird bios product creation efforts is its broadly applicable gene therapy platform for the development of novel treatments for diseases with few or no clinical options. The companys novel approach uses stem cells harvested from the patients own bone marrow into which a healthy version of the disease causing gene is inserted. bluebird bios approach represents a true paradigm shift in the treatment of severe genetic diseases by eliminating the potential complications associated with donor cell transplantation and potentially presenting a one-time transformative therapy using a patients own stem cells. bluebird bio has two later stage clinical products in development for childhood cerebral adrenoleukodystrophy (CCALD) and beta-thalassemia/sickle cell disease. Led by a world-class team, its operations are located in Cambridge, Mass., San Francisco and Paris, France. For more information, please visit http://www.bluebirdbio.com.

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bluebird bio Awarded $9.3 Million From the California Institute for Regenerative Medicine to Further Gene Therapy ...

Public release date: 24-Oct-2012 [ | E-mail | Share ]

Contact: Jim Newman newmanj@ohsu.edu 503-494-8231 Oregon Health & Science University

PORTLAND, Ore. - Oregon Health & Science University's development of a new gene therapy method to prevent certain inherited diseases has reached a significant milestone. Researchers at the university's Oregon National Primate Research Center and the OHSU Department of Obstetrics & Gynecology have successfully demonstrated their procedure in human cells. It's believed that this research, along with other efforts, will pave the way for future clinical trials in human subjects.

The research results are online Wednesday, Oct. 24, in the highly respected journal Nature. Dr. Mitalipov also will present the results of his research at the American Society for Reproductive Medicine Conference in San Diego Oct. 24'.

The OHSU gene therapy method was initially devised through research in nonhuman primates led by Shoukhrat Mitalipov, Ph.D., associate scientist in the Division of Reproductive & Developmental Sciences at ONPRC, Oregon Stem Cell Center and OHSU School of Medicine departments of Obstetrics and Gynecology and Molecular and Medical Genetics.

The procedure was specifically developed to prevent diseases related to gene defects in the cell mitochondria. Mitalipov's previous work was published in the August 2009 edition of Nature. In the current study, Mitalipov, in collaboration with Paula Amato, M.D., associate professor of obstetrics and gynecology in the OHSU Center for Women's Health, demonstrated efficacy of this therapy in human gametes and embryos.

"Cell mitochondria contain genetic material just like the cell nucleus and these genes are passed from mother to infant," explained Mitalipov. "When certain mutations in mitochondrial DNA are present, a child can be born with severe conditions, including diabetes, deafness, eye disorders, gastrointestinal disorders, heart disease, dementia and several other neurological diseases. Because mitochondrial-based genetic diseases are passed from one generation to the next, the risk of disease is often quite clear. The goal of this research is to develop a therapy to prevent transmission of these disease-causing gene mutations."

To conduct this research, Mitalipov and his colleagues obtained 106 human egg cells from study volunteers recruited through OHSU's Division of Fertility and Reproductive Endocrinology. The researchers then used a method developed in previous nonhuman primate studies, to transfer the nucleus from one cell to another. In effect, the researchers "swapped out" the cell cytoplasm, which contains the mitochondria. The egg cells were then fertilized to determine whether the transfer was a success and whether the cells developed normally. Upon inspection, it was demonstrated that it was possible to successfully replace mitochondrial DNA using this method.

"Using this process, we have shown that mutated DNA from the mitochondria can be replaced with healthy copies in human cells," explained Mitalipov. "While the human cells in our study only allowed to develop to the embryonic stem cell stage, this research shows that this gene therapy method may well be a viable alternative for preventing devastating diseases passed from mother to infant."

The current Nature paper also expanded upon the previously reported nonhuman primate work by demonstrating that the method was possible using frozen egg cells. Mitochondria were replaced in a frozen/thawed monkey egg cell, resulting in the birth of a healthy baby monkey named Chrysta.

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OHSU researchers test new gene therapy method in human cells... and it works

ScienceDaily (Oct. 24, 2012) Oregon Health & Science University's development of a new gene therapy method to prevent certain inherited diseases has reached a significant milestone. Researchers at the university's Oregon National Primate Research Center and the OHSU Department of Obstetrics & Gynecology have successfully demonstrated their procedure in human cells. It's believed that this research, along with other efforts, will pave the way for future clinical trials in human subjects.

The research results are online Oct. 24, in the journal Nature. Dr. Mitalipov also will present the results of his research at the American Society for Reproductive Medicine Conference in San Diego Oct. 24

The OHSU gene therapy method was initially devised through research in nonhuman primates led by Shoukhrat Mitalipov, Ph.D., associate scientist in the Division of Reproductive & Developmental Sciences at ONPRC, Oregon Stem Cell Center and OHSU School of Medicine departments of Obstetrics and Gynecology and Molecular and Medical Genetics.

The procedure was specifically developed to prevent diseases related to gene defects in the cell mitochondria. Mitalipov's previous work was published in the August 2009 edition of Nature. In the current study, Mitalipov, in collaboration with Paula Amato, M.D., associate professor of obstetrics and gynecology in the OHSU Center for Women's Health, demonstrated efficacy of this therapy in human gametes and embryos.

"Cell mitochondria contain genetic material just like the cell nucleus and these genes are passed from mother to infant," explained Mitalipov. "When certain mutations in mitochondrial DNA are present, a child can be born with severe conditions, including diabetes, deafness, eye disorders, gastrointestinal disorders, heart disease, dementia and several other neurological diseases. Because mitochondrial-based genetic diseases are passed from one generation to the next, the risk of disease is often quite clear. The goal of this research is to develop a therapy to prevent transmission of these disease-causing gene mutations."

To conduct this research, Mitalipov and his colleagues obtained 106 human egg cells from study volunteers recruited through OHSU's Division of Fertility and Reproductive Endocrinology. The researchers then used a method developed in previous nonhuman primate studies, to transfer the nucleus from one cell to another. In effect, the researchers "swapped out" the cell cytoplasm, which contains the mitochondria. The egg cells were then fertilized to determine whether the transfer was a success and whether the cells developed normally. Upon inspection, it was demonstrated that it was possible to successfully replace mitochondrial DNA using this method.

"Using this process, we have shown that mutated DNA from the mitochondria can be replaced with healthy copies in human cells," explained Mitalipov. "While the human cells in our study were allowed to develop to the embryonic stem cell stage, this research shows that this gene therapy method may well be a viable alternative for preventing devastating diseases passed from mother to infant."

The current Nature paper also expanded upon the previously reported nonhuman primate work by demonstrating that the method was possible using frozen egg cells. Mitochondria were replaced in a frozen/thawed monkey egg cell, resulting in the birth of a healthy baby monkey named Chrysta.

The second portion of the study, which was completed at ONPRC, is also considered an important achievement because egg cells only remain viable for a short period of time after they are harvested from a donor. Therefore, for this therapy to be a viable option in the clinic, preservation through freezing likely is necessary so that both the donor cell and a mother's cell are viable at the time of the procedure.

While this form of therapy has yet to be approved in the United States, the United Kingdom is seriously considering its use for treating human patients at risk for mitochondria-based disease. It's believed that this most recent breakthrough, combined with earlier animal studies, will help inform that decision-making process.

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New gene therapy method tested in human cells ... and it works, researchers report

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