Volume 9.06 | Feb 18

Cell Therapy News 9.06, February 18, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Show Stem Cells Don’t Cause Cancer: A major concern with using stem cells to treat disease has been the possibility that the retrovirus used to implant the cells might cause cancer, but now a group of scientists appears to have solved that problem.
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Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival: Researchers from Dendreon Corporation have presented data demonstrating the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T), an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival.
Article

Science

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Scientists at UCLA Reprogram Human Skin Cells into Embryonic Stem Cells
UCLA stem cell scientists have reprogrammed human skin cells into cells with the same unlimited properties as embryonic stem cells, without using embryos or eggs.
Article

Functional Immune System Can Be Derived From Embryonic Stem Cells
A new study demonstrates for the first time that embryonic stem cells can be used to create functional immune system blood cells, a finding which is an important step in the utilization of embryonic stem cells as an alternative source of cells for bone marrow transplantation.
Article

Plucking Cells out of the Bloodstream
A new implantable device can extract stem cells for therapeutic transplant or program cancer cells to die.
Article

Scientists Solve Gene Therapy Mystery
The University of Glasgow team, in collaboration with colleagues at University College London and the Medical Research Council Clinical Sciences Centre, worked with adenoviruses, a class of virus that cause respiratory, intestinal, and eye infections in humans. They were then mutated to allow them to be used in the gene therapy treatment.
Article

Vaccine Protects Against Prostate Cancer in Mice
An experimental vaccine can provide long-term protection against prostate cancer in mice genetically predisposed to the disease, new research indicates.
Article

Transplanted Liver Lining Cells May Cure Hemophilia
Scientists have shown that transplanting healthy liver cells into mice with hemophilia enables the animals to produce a critical clotting factor missing in humans with type A hemophilia.
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Human Stem Cell Tests Could Be Near
Geron CEO plans embryonic stem cell tests in humans this spring if the biotech meets the FDA’s ‘high bar.’
Article

Pioneering New Islet Transplantation for Patients with Type 1 Diabetes
A team led by Dr Richard Smith, Consultant Senior Lecturer in Renal Medicine at North Bristol NHS Trust and the University of Bristol, will offer a pioneering new treatment for some patients with Type 1 diabetes.
Article

HepaLife’s Bioartificial Liver Dramatically Reduces Toxic Marker for Acute Liver Failure
HepaLife Technologies, Inc. has announced important, positive results from new in-vitro studies in which the Company’s patented PICM-19 liver stem cells were placed inside its proprietary bioartificial liver device and were able to successfully and quickly remove high levels of toxic ammonia within a very short period of time.
Article

Highly Successful Results of Bone Repair Trial Show that Mesoblast’s Stem Cells Promote and Repair Fracture Healing
Mesoblast Limited has announced highly successful results from its clinical trial at The Royal Melbourne Hospital in 10 patients suffering from non-healing, long bone fractures of the legs.
Article

Gene Therapy Protocol at UCSD Activates Immune System in Patients with Leukemia
A research team at the Rebecca and John Moores UCSD Cancer Center at University of California, San Diego reports that patients with chronic lymphocytic leukemia who were treated with a gene therapy protocol began making antibodies that reacted against their own leukemia cells.
Article

Diamyd Medical Receives FDA Approval to Initiate Clinical Study in Chronic Pain
Diamyd Medical has announced that it has received approval from the U.S. FDA to initiate a Phase I study in chronic pain using NP2, the company’s first drug candidate in its Nerve Targeting Drug Delivery System gene therapy platform.
Article

Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
Cell Genesys, Inc. reports the results of an analysis examining the potential association between immune responses to GVAX immunotherapy for prostate cancer and increased patient survival in a Phase 2 trial in patients with metastatic, hormone refractory prostate cancer.
Article

Polyplus Gene Delivery Tool Poised for Phase II
A Phase II clinical trial using French company Polyplus-transfection’s innovative gene delivery tool, in vivo-jetPEI, is set to go ahead this month in Europe and the US.
Article

Dendreon Will Have to Wait for FDA
A congressional committee said Wednesday that it would not hold a hearing to investigate possile conflicts of interests relating to the FDA’s decision to delay approval of Provenge, a drug developed by Dendreon Corp. of Seattle.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Stem Cells: In Search of Common Ground
With the number of stem-cell lines rapidly increasing, technology developers are working to improve systems for culturing and efficient differentiation – all with an eye on the clinic.
Abstract

Concise Review: Isolation and Characterization of Cells from Human Term Placenta: Outcome of the First International Workshop on Placenta Derived Stem Cells
The aim of this review is to summarize and provide the state of the art of research in this field, addressing aspects such as cell isolation protocols and characteristics of these cells, as well as providing preliminary indications of the possibilities for use of these cells in future clinical applications.
Abstract

JOB OPPORTUNITIES

Cell Therapy Business Development Leader
Portland, OR (Invitrogen)
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Scientist
Irvine, CA (Global Biopharmaceutical Company)
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Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)
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Quality Manager
Singapore (Singapore Cord Blood Bank)
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Policy

German Parliament Considers Changing Stem Cell Laws
German lawmakers are considering changes to laws on stem cell research as pressure grows for an easing of restrictions that local scientists complain prevent them from keeping up with global advances.
Article

Competition Heavy for State Stem Cell Research Funds
The Maryland Stem Cell Research Commission said Wednesday it has received 122 requests for grants from the state organization’s 2008 research fund.
Article

CIRM Fights Allegations of ‘Laundering’ PR Advice
The California Institute for Regenerative Medicine (CIRM) is fending off accusations from a watchdog group that it “laundered” PR advice through its law firm in order to keep the advice secret.
Article

Massachusetts Bill Bolsters Life Sciences Sector
A $1 billion life sciences bill unveiled by House lawmakers Thursday aims to produce jobs and cure diseases by providing universities and businesses with incentives and tools to expand their stem cell research in the state.
Article

Business

StemLab Webinar: Tracking Lot-to-Lot Traceability for your Cell Therapy Products
StemSoft Software Inc is pleased to announce their inaugural webinar presentation. The 30-minute webinar will highlight the features of the StemLab(TM) system that give cell processing laboratories the ability to completely track lot-to-lot traceability for all their products.
Article

Plasticell Acquires Rights to Two Further Human Embryonic Stem Cell Lines from King’s College London
Plasticell has entered into an agreement with King’s College London to exploit and market two human embryonic stem cell lines.
Article

Cancer Pioneer Reaches Key Agreement on Colon Cancer Drug OncoVAX(R)
Cancer research pioneer Michael G. Hanna Jr. Ph.D., also Vaccinogen, Inc.’s Founder, Chairman and CEO, has acquired the rights to OncoVAX(R), a vaccine with the potential to prevent colon cancer from recurring in many patients.
Article

Invitrogen Announces Minority Investment in Q Therapeutics
Invitrogen Corporation has announced it has made a minority investment in Q Therapeutics, a biotechnology company pursuing cell therapeutic indications for the central nervous system.
Article

Stem Cell ScienceS Implements Stategic Reorganization
Stem Cell Sciences plc has announced the implementation of a comprehensive restructuring programme, designed to improve financial, operational and growth performance, as well as provide a greater focus on its commercialisation efforts in the application of stem cell technologies.
Article

Living Cell Technologies Ltd Company Announcement: Diabetes Trial Supported by US-Based Diabetes Foundation
Living Cell Technologies Limited has announced that the US-based Children with Diabetes Foundation has offered its support in raising funds for LCT’s DiabeCell(R) clinical trials for people with type 1 diabetes.
Article

Ark Completes Work to Validate its GMP Gene Medicine Production Facility to US Standards
Ark Therapeutics Group plc announces that it has completed the detailed review of facility validation and documentation upgrades to enable its Finnish gene therapy manufacturing facility to meet US as well as European Good Manufacturing Practice (GMP) standards.
Article

Company Launches First-Ever Direct-To-Consumer Campaign of a Living Cell-Based Therapy
Organogenesis, Inc. is launching the first-ever direct-to-consumer educational campaign for a living cell-based therapy.
Article

Opexa Therapeutics Announces the Pricing of Public Offering of Shares of Common Stock and Series E Warrants
Opexa Therapeutics, Inc. has announced that it has priced a public offering of 3,500,000 shares of common stock at a price to the public of $2.00 per share and 3,500,000 Series E warrants to purchase shares of common stock exercisable at $2.00 per share at a price of $0.15 per warrant.
Article

Aastrom Biosciences Announces Transition of Duties
Aastrom Biosciences, Inc. has announced that Gerald D. Brennan, Jr., Vice President, Administrative & Financial Operations and Chief Financial Officer, has announced his intention to retire from the Company and has requested that the Company initiate a search for his successor.
Article

Alberto-Culver Founder Leonard Lavin Joins Histogen Board of Directors
Histogen, Inc. has announced that Leonard Lavin, founder and chairman emeritus of the Alberto-Culver Company, has joined Histogen’s Board of Directors.
Article

NIH

NIDCD-Supported Research on Stem Cells and Hearing Loss, Music through the Cochlear Implant and a Virtual Grocery Store for People with Balance Disorders Featured at ARO Conference in Phoenix
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Notice of Legislative Mandates in Effect for FY 2008 (NOT-OD-08-041)
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National Animal Welfare Education Program Workshops and Conferences for 2008 (NOT-OD-08-043)
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March IACUC 101 Workshop and PRIM&R 2008 Annual IACUC Conference in Atlanta, Georgia (NOT-OD-08-044)
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April IACUC 101 Workshop in Galveston, Texas (NOT-OD-08-045)
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Extension of Receipt Date for Notice of Request for Information (RFI) on Cancer and Normal Tissue Acquisition and Processing Variables (NOT-CA-08-012)
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Request for Information (RFI): NHLBI/NCI RAID Program for Heart, Lung, and Blood Disorders (NOT-HL-08-111)
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CBER

Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products
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The Eleventh US-Japan Cellular and Gene Therapy Conference on Tissue Engineering
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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Stupak Calls for FDA Resignation
A key House Democrat said Thursday that the head of the Food and Drug Administration should resign in the wake of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.
Article

CDER Slated for 283 New Staff in Proposed Fiscal 2009 Budget
The president’s fiscal 2009 budget request for the FDA includes an estimated 526 new full-time equivalent employees, 283 for Center for Drug Evaluation and Research (CDER) alone. Twenty-six new employees would be in the Center for Biologics Evaluation and Research (CBER), 161 would be in the Office of Regulatory Affairs (ORA) and five would be in the FDA Headquarters and the Office of the Commissioner, according to the FDA.
Article

ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: http://www.celltherapysociety.org



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