Volume 8.46 | Nov 26

Volume 8.46, November 26, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Treats Parkinson’s: An experimental form of gene therapy for Parkinson’s disease has been shown to produce promising results.


Introductory Pricing for Cell Therapy News Job Postings Ends December 1, 2007
Click here to begin recruiting for cell therapy-related job openings at your company or institution.

Drug Firms Cool to Stem Cell Findings
Despite excitement among some scientists – and at the White House – about an embryo-free technique for creating human stem cells, reaction from companies that might turn the research into treatments was muted.

Dolly Scientist Abandons Cloning
The scientist who led the team that controversially created Dolly the sheep is abandoning the cloning of human embryos in stem cell research.

Covalon Achieves Important Milestone in Its Cell-Based Gene Therapy for Treating Congestive Heart Failure and Tissue Regeneration
Covalon Technologies Ltd. is pleased to announce that it has successfully achieved an important milestone with its EPAS1 technology that is expected to allow Covalon to engineer mesenchymal stem cells for increased expression of EPAS1, a hypoxia inducible factor.

St. Jude Finds Molecule that Could Improve Cancer Vaccines and Therapy for Other Diseases
Investigators at St. Jude Children’s Research Hospital have discovered a new signaling molecule that prevents immune responses from running amok and damaging the body.

Immune System Can Drive Cancers Into Dormant State
A multinational team of researchers has shown for the first time that the immune system can stop the growth of a cancerous tumor without actually killing it.

Stem Cell Injection Protects Against Nerve Cell Death After Stroke, Study Suggest
Scientists have tested the capabilities of cellular therapy for ischemic stroke treatment on rats. It has turned out that intravenous transplantation of mesenchymal stem cells restores cerebrum blood supply and protects its nerve cells from death.

Stem Cell Transplant Can Grow New Immune System in Certain Mice, Stanford Researchers Find
The researchers found a way to transplant new blood-forming stem cells into the bone marrow of mice, effectively replacing their immune systems.

Gene Therapy Safety Trial for Childhood Blindness Under Way
A gene-transfer technique is being tested for safety in people in a phase 1 clinical research study conducted by the University of Pennsylvania and the University of Florida with support from the National Eye Institute of the National Institutes of Health.

Athersys IND For MultiStem Authorized For Phase I Clinical Trial In Bone Marrow Transplant Support
Athersys, Inc. announced that it has been notified by the U.S. Food and Drug Administration that its Investigational New Drug, MultiStem(r), can proceed to a Phase I clinical trial evaluating the safety of MultiStem administration in support of bone marrow transplantation for the treatment of certain cancers of the blood and immune system.

Biobanks Now Feasible in Developing Countries
Technological advances and other innovations have made it feasible for developing countries to establish biobanks – repositories of human biological samples linked with data from individuals, write S. K. Sgaier and colleagues in Science.


A Roadmap to Safe, Efficient, and Stable Lentivirus-Mediated Gene Therapy with Hematopoietic Cell Transplantation
This review summarizes the state of the field today in terms of vector development and clinical experimentation. In particular, concerns with the safety of retroviral vectors intended for clinical gene transfer, applicability of preclinical data in directing clinical trial design, and recent research aimed at resolving some of these issues are addressed. Finally, this review underlines the specific advantages offered by lentiviral gene-transfer vectors for gene therapy in stem cells.


Clinical Development Research Associate
Poway, California (VetStem)

Islet Cell Associate Research Director
Irvine, CA (University of California, Irvine)


State Stem Cell Board Member Asked to Quit Over Apparent Conflict
A prominent member of the governing board for California’s stem cell agency may have violated state conflict-of-interest rules last summer when he tried to reverse a decision rejecting a grant proposal by a scientist who works for him at the Burnham Institute of Medical Research in La Jolla.

State Stem Cell Chief’s Ex-colleague Cited in Research Scandal
An Australian scientist who had worked closely with Alan Trounson, the newly named chief of California’s $3 billion stem cell program, has been cited for “research misconduct” in an Australian university probe of a scuttled government-funded study.


Neuralstem Obtains UCSD Stem Cell Delivery System for Use in Spinal Cord Trials
Stem cell company, Neuralstem, Inc. , has announced that it has exclusively licensed the “Spinal Multisegmental Cell and Drug Delivery System,” invented by Dr. Martin Marsala at the University of California, San Diego.

Partnership Formed to Develop Bone Marrow Stem Cell Technology
The University of Louisville has announced a partnership between the UofL Research Foundation and NeoStem Inc., a New York City-based adult stem cell company, to develop Very Small Embryonic-Like stem cell (VSEL) technology.

Johnson & Johnson Subsidiary Licenses Argos Technology
Argos Therapeutics has licensed one of its non-core drug technologies to a subsidiary of Johnson & Johnson, it said Friday. The Durham company said Therakos, a J&J company focused on therapies for immune diseases, will develop drugs based on Argos’ “regulatory T cell” technology.

Exelixis Sells 80% Stake in Artemis to Taconic
Exelixis, Inc. has announced that it has entered into an agreement with Taconic Farms, Inc. pursuant to which Exelixis sold Taconic an 80.1% stake in its subsidiary Artemis Pharmaceuticals GmbH for approximately $20 million, subject to certain post-closing adjustments.

Exclusive Stem Cell Centre Launched
LifeCell has joined hands with the city-based Sri Ramachandra University to launch “TRICell,” an exclusive stem cell centre for stem cell transplants and research.

Stem Cell Sciences Appoints Alastair Riddell as CEO
Dr. Riddell brings to SCS extensive experience in the biotech industry, with more than 10 years experience at Board level in building companies, raising financing and negotiating deals for both public and private companies.

Osiris Therapeutics Announces Management Change
Osiris Therapeutics has announced that Cary J. Claiborne, Chief Financial Officer, has left the Company effective today, to pursue new professional opportunities.

Mesoblast Appoints New Non Executive Chairman
Australia’s adult stem cell company, Mesoblast Limited has announced the appointment of Mr Brian Jamieson as Non-Executive Chairman, effective from 22 November 2007.


NIH-RAID Pilot – Updates on Program Scope and Procedures (NOT-RM-08-005)

Addition to Application Requirements for RFA-RM-08-013 2008 NIH Director’s Pioneer Award Program (DP1) (NOT-RM-08-006)

Quick-Trials for Novel Cancer Therapies and Prevention: Exploratory Grants (R21) (PAR-08-025)


Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes – Implementation date change

All new CBER information can be reached from the What’s New page at What’s New Page



Duke, FDA Put Clinical Trials on the Examining Table
Duke University Medical Center and the FDA are set to launch a partnership to try to improve the nation’s clunky clinical-trials process.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Draft Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings; Availability



ISCT is proud to present: “Overview of GCP for Cell Therapy”

Date: Wednesday November 28th, 2007
Time: 12pm ET – 1pm ET

Registration Rates (Nov 17th – Nov 26th)
ISCT Member     $90        
Non-Member      $105       

Please visit www.celltherapysociety.org for more information.

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