Volume 9.21 | Jun 2

Cell Therapy News 9.21, June 2, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Johns Hopkins Researchers Develop Human Stem Cell Line Containing Sickle Cell Anemia Mutation: Researchers at Johns Hopkins have established a human cell-based system for studying sickle cell anemia by reprogramming somatic cells to an embryonic stem cell like state. Publishing online in Stem Cells on May 29, the team describes a faster and more efficient method of reprogramming cells that might speed the development of stem cell therapies.
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Science

USC Stem Cell Study Sheds New Light on Cell Mechanism
Research from the University of Southern California has discovered a new mechanism to allow embryonic stem cells to divide indefinitely and remain undifferentiated.
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New Insights into Cellular Reprogramming Revealed by Genomic Analysis
Recently, thanks to the application of powerful new integrative genomic tools, a cross-disciplinary research team from Harvard University, Whitehead Institute, and the Broad Institute of MIT and Harvard has uncovered significant new information about the molecular changes that underlie the direct reprogramming process.
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Origin of Cells for Connective Tissues of Skull and Face Challenged
With improved resolution, tissue-specific molecular markers and precise timing, University of Oregon biologist James A. Weston and colleagues have possibly overturned a long-standing assumption about the origin of embryonic cells that give rise to connective and skeletal tissues that form the base of the skull and facial structures in back-boned creatures from fish to humans.
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Life, But Not As We Know It?
Dr Cameron Alexander and PhD student George Pasparakis in the University’s School of Pharmacy have used polymers – long-chain molecules – to construct capsule-like structures that have properties mimicking the surfaces of a real cell.
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Cell ‘Organs’ Get Plastic Upgrades
Human cells could have their metabolisms upgraded without altering their genes by inserting tiny plastic packages of enzymes, Swiss researchers have shown. They hope the technique could allow advanced cancer therapies, or even upgrade a person’s metabolism.
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Artificial Virus for ‘Tailor-Made Gene Therapy’
An artificial self-assembling virus capable of serving as a drug delivery system has been created by researchers in Korea, according to a publication in Angewandte Chemie.
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Covalon Achieves Another Important Preclinical Milestone in its EPAS-1 Research Project for Treating Congestive Heart Failure and Tissue Regeneration
The EPAS-1 research project is expected to allow Covalon to produce “universal donor” mesenchymal stem cells that can be used by all individuals for use in myocardial preservation by therapeutic cell transplantation following loss of blood flow due to coronary vessel occlusion.  The use of a “universal donor” will allow for simplification and standardization of procedures related to stem cell therapy including cardiovascular disease and generally in regenerative medicine.
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Pluristem Demonstrates the Potential of Its PLX Cells to Treat Crohn’s Disease and Ulcerative Colitis
Pluristem Therapeutics Inc. recently announced that the Company’s PLacental eXpanded cells have demonstrated in vivo efficacy in the treatment of Crohn’s Disease and Ulcerative Colitis, collectively termed Inflammatory Bowel Disease.
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BrainStorm Cell Therapeutics NTF Cells Shows Significant Advantage in Pre-Clinical Study for Parkinson’s Disease
BrainStorm Cell Therapeutics Inc. announced recently that in a pre-clinical study that was conducted with Tel Aviv University between February and May 2008, signs of impaired motor behavior in a rat model of Parkinson’s improved following transplantation of BrainStorm’s unique Neurotrophic Factor Cells.
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Vancouver Researchers Pioneer Safe Pathway to Slow ALS Using Stem Cells
A unique pilot study has established a safe pathway for using bone-marrow stem cells to slow down and potentially treat Amyotrophic Lateral Sclerosis, a fatal neurodegenerative disease without cure.
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AMT Announces Positive Interim Clinical Data on its Lead Product AMT-011
Amsterdam Molecular Therapeutics recently announced that positive interim data from its pivotal clinical trial with AMT’s lead product Glybera(R) (AMT-011) were presented by the Principal Investigator, professor Daniel Gaudet, at the American Society of Gene Therapy Annual Meeting in Boston on May 29th. These data confirm the outcome of a previous study conducted in The Netherlands, demonstrating safety and efficacy of Glybera(R) for lipoprotein-lipase deficiency, a disease also known as Hyperlipoproteinemia type I.
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ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
ViroPharma Incorporated recently announced that it completed enrollment in its pivotal Phase 3 study of maribavir in stem cell transplant patients. This international Phase 3 study is evaluating the efficacy, safety and tolerability of prophylactic use of maribavir administered orally for up to 12 weeks for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplants.
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StemCells Confirms Previously Reported Batten Trial Death Was Due to Natural Progression of Disease
StemCells, Inc. recently provided additional information about the patient in the Company’s Phase I clinical trial of HuCNS-SC (R) cells (purified human neural stem cells) whose death was previously reported in January 2008. Based on autopsy results and medical records, the principal investigators for the trial, the Company’s medical experts and an independent Data Safety Monitoring Committee have all confirmed their preliminary judgment that the death was due to the natural progression of the disease.
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Bioreactors and Surfaced-Modified 3D-Scaffolds for Stem Cell Research
In this interview, Karl-Freidrich Weibezahn discusses the latest generation of 3D-scaffolds as opposed to previously used monolayer cultures.
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RNAi Researchers Galvanized by Advances
If there is one thing that researchers agree on, it’s that now is a good time to be working with RNA interference. RNAi is a natural cellular mechanism that regulates gene expression at the stage of translation by degrading the mRNA or blocking translation. It can also alter the level of transcription of specific genes
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Efficient Differentiation of Functional Hepatocytes from Human Embryonic Stem Cells
Differentiation of human embryonic stem cells to specific functional cell types can be achieved using methods that mimic in vivo embryonic developmental programs. The researchers report here a robust and highly efficient process for the generation of high-purity (70%) hepatocyte cultures from hESCs that parallels sequential hepatic development in vivo.
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Hoxb1 Controls Cell Fate Specification and Proliferative Capacity of Neural Stem and Progenitor Cells
In this study, researchers find that timely induction of a Hoxb1 transgene in ESC-derived neural stem cells (NSCs) resulted in the specification of NSCs towards a hindbrain specific identity through the activation of a rhombomere 4-specific genetic program and the repression of anterior neural identity.
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Hedgehog Serves as a Mitogen and Survival Factor During Embryonic Stem Cell Neurogenesis
Within the vertebrate central nervous system, Sonic Hedgehog can act as a morphogen or mitogen that regulates the patterning, proliferation, and survival of neural stem cells. The researchers show here that ESC differentiation in adherent culture follows the ESC-> primitive ectoderm -> neurectoderm transitions observed in vivo. Selective death of the Sox1-GFP-negative cells contributes to the enrichment of Sox1-GFP-positive NSCs.
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Policy

Brazil Court to Decide on Embryonic Cell Research
Brazil’s Supreme Court started voting on Wednesday on whether to uphold legislation that allows research on embryonic stem cells in the world’s largest Roman Catholic country.
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Stem Cell Research Could Block Good Laws
A breakthrough in stem cell research may actually be used as a reason to defeat proposed state legislation aimed at paving the way for further scientific discoveries, a senator says.
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RM32 Million for Stem Cell Research in Malaysia
Malaysia is showing its support for stem cell research by approving a RM32 million allocation to develop and strengthen stem cell and cord blood banking activities in the country.
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Business

StemSoft and BioE to Offer Quality-Driven, Turnkey Solution for Cord Blood Data Management and Processing
StemSoft Software Inc. and BioE, Inc. announced recently they have entered into a partnership to provide cord blood banks a complete, quality-driven turnkey solution for comprehensive cord blood data management and cord blood processing.
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Alnylam and Takeda Form Strategic Worldwide Platform Alliance in RNAi Therapeutics
Alnylam Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited recently announced that they have formed a strategic platform alliance in RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas. This landmark alliance is the first major RNAi therapeutics partnership between a Japanese pharmaceutical company and a U.S. biotechnology company, representing a new frontier in the advancement of RNAi therapeutics to patients on a global basis.
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Isis to Receive $4.6 Million From Alnylam
Isis Pharmaceuticals, Inc. announced recently that it will receive $4.6 million dollars from Alnylam Pharmaceuticals, Inc. as its portion of the upfront fees in the recently announced transaction between Takeda Pharmaceutical Company Limited and Alnylam. In addition, Isis has the potential to receive portions of future milestone and royalty payments. This transaction further emphasizes the value of Isis’ innovation and the leadership role Isis has played in the field of nucleic acid based therapeutics.
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AMT’s Cooperative Research and Development Agreement With NIH to Boost Production Capacity
Amsterdam Molecular Therapeutics recently announced that it obtained a Cooperative Research and Development Agreement from the National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland, that promises to substantially enhance the power of AMT’s gene therapy platform.
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Inovio Biomedical Licenses Electroporation Delivery Technology to Leading U.S. Government Contractor, Advanced BioScience Laboratories, Inc.
Inovio Biomedical Corporation announced recently that it has entered into a license agreement with Advanced BioScience Laboratories, Inc. that ABL may provide advanced electroporation delivery of DNA vaccines for its research uses.
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New York Firm Signs Stem Cell Collection Agreement with Brown Cancer Center
New York City-based NeoStem Inc., which in November acquired exclusive rights to stem cell technology developed by University of Louisville researchers, announced Tuesday that it had signed a collection center agreement with the University of Louisville Hospital’s James Graham Brown Cancer Center.
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CellCyte Genetics Signs Collaborative Agreement With Northwestern University’s Feinberg School of Medicine to Perform Disease Model Outcome Study of CellCyte’s CCG-TH30 Product Candidate
CellCyte Genetics Corporation has entered into a collaborative research agreement with Northwestern University’s Feinberg School of Medicine to perform an acute myocardial infarction disease model study in mice using CellCyte’s CCG-TH30 product candidate. The goal of the study is to evaluate the functional benefit of the CCG-TH30 therapy in a disease model outcome study representative of the AMI (heart attack) indication.
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ReNeuron Signs Contract with Angel Biotechnology to Manufacture ReN001 Stem Cells for UK Clinical Trials in Stroke
Under the contract, Angel will manufacture clinical-grade batches of ReNeuron’s ReN001 stem cells in Angel’s MHRA1-licensed facility in Scotland. The manufactured materials will be used to provide ReNeuron with further product data required for eventual clinical trial approval of ReNeuron’s ReN001 stroke therapy by the UK regulatory authorities.
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HHMI Selects 56 of the Nation’s Top Scientists
Fifty-six of the nation’s most creative biomedical scientists are being given the opportunity to tackle their most ambitious, risky research plans, as they become the newest class of Howard Hughes Medical Institute investigators. The Institute is committing more than $600 million over their first term of appointment.
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Bioheart, Inc. Reports Receipt of Notification from NASDAQ Regarding Non-Compliance with Continued Listing Requirements
Bioheart, Inc. BHRT announced that on May 21, 2008 it received a letter from the Nasdaq Stock Market advising that, for the last 10 consecutive trading days, the Company’s market value of listed securities had been below the minimum $50,000,000 requirement for continued inclusion on The Nasdaq Global Market pursuant to Nasdaq Marketplace Rule 4450(b)(1)(A).
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Genitope Corporation Announces Receipt of Nasdaq Determination
Genitope Corporation recently announced that, on May 21, 2008, it received a staff determination letter from The Nasdaq Stock Market indicating that, as a result of the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, Genitope no longer complied with Nasdaq’s filing requirements for continued listing as set forth in Marketplace Rule 4310(c)(14), and that its securities are, therefore, subject to trading suspension and delisting.
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NIH

Francis S. Collins to Step Down as Director of National Human Genome Research Institute
Francis S. Collins, M.D., Ph.D., the director of the National Human Genome Research Institute, part of the National Institutes of Health, recently announced his intention to step down on August 1 to explore writing projects and other professional opportunities.
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CBER

Meeting for Public Comment on the Pilot Program to Evaluate Proposed Name Submissions
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FDA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07)
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

FDA & EMEA to Increase Cooperation
The Transatlantic Economic Council has set out its vision of how increased cooperation between the US and European Union can improve the pharmaceutical regulatory process.
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Laboratory Equipment Recall Associated with IVF, Cells, Tissues: Automated Cryopreservation and Storage System – ThermoGenesis Corp – Vapor By-Pass Assembly, 220 VAC 50/60 Hz
Device is to be exchanged. Return of specified lots/batches of the device to the manufacturer or its representative. Advice has been given by the manufacturer regarding the use of the device.
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