Volume 8.49 | Dec 17

Volume 8.49, December 17, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Dendreon Shares Rise After Call for FDA Investigation: Shares in Dendreon Corp. shot up more than 23 percent Thursday after several U.S. congressmen requested a “conflicts of interests” investigation into the Food and Drug Administration’s delay in approving the Seattle biotech’s Provenge drug for prostate cancer.
Article

Stem Cell Therapy Counters Muscular Dystrophy in Mice: Scientists have demonstrated that a combination of stem cell and gene therapy can be used to correct the devastating hereditary disease of muscular dystrophy.
Article

Science

Personalized Medicine through Genomic Analysis and Molecular Diagnostics
March 31, 2008
Boston, Massachusetts

Enter "CONNEXON" at checkout and receive 10% off registration.
Click here to register today.

The Guts of a Cell, Frozen in Time
A novel 3-D imaging technique provides a first look at the internal structure of human skin cells.
Article

Stanford Researchers Identify Granddaddy of Human Blood Cells
Researchers at the Stanford University School of Medicine have isolated a human blood cell that represents the great-grandparent of all the cells of the blood, a finding that could lead to new treatments for blood cancers and other blood diseases.
Article

Scientists Overcome Obstacles to Stem Cell Heart Repair
Scientists funded by the Biotechnology and Biological Sciences Research Council at Imperial College London have overcome two significant obstacles on the road to harnessing stem cells to build patches for damaged hearts.
Article

Transplanted Bone Marrow Cells Aid Nerve Regeneration
Transplanted bone marrow cells containing adult stem cells can help regenerate damaged nerves, say Japanese researchers.
Article

Adipose-Derived Stem & Regenerative Cells Improve Fat Graft Retention in Preclinical Study
Cytori Therapeutics, Inc. reported positive preclinical results demonstrating adipose-derived stem and regenerative cells improved the quality and long-term retention of a fat graft, representing a potential new approach in reconstructive surgery.
Article

Genitope Corporation Presents New Data On Its Therapeutic Monoclonal Antibodies To Potentially Treat B-Cell Malignancies
Genitope Corporation has announced results of two pre-clinical studies, which demonstrated the proof of concept of the company’s monoclonal antibody program to treat B-cell malignancies such as non-Hodgkin’s lymphoma.
Article

MicroIslet Holds Positive Pre-IND Meeting for US Based Human Clinical Trial With FDA
MicroIslet, Inc. announced that it has met with the U.S. Food and Drug Administration to discuss requirements for the filing of an Investigational New Drug application for MicroIslet-P(TM), a microencapsulated suspension of pancreatic islet cells.
Article

Ireland Cancer Center Researchers Advance Stem Cell Gene Therapy
Ireland Cancer Center of University Hospitals Case Medical Center researchers have recently made great strides in stem cell gene therapy research by transferring a new gene to cancer patients, via their own stem cells, with the ultimate goal of being able to use stronger chemotherapy treatment with less severe side effects.
Article

AVAX Technologies Announces Successful Completion of Phase I/II Study of MVax(R) in Patients with Stage 3 and 4 Melanoma
AVAX Technologies, Inc. has announced the completion of its Phase I/II study for the treatment of patients with melanoma.
Article

Ultrasound for Open Leg Ulcers
For skin transplants to "take root", it needs to be ensured that the patient’s tissue is properly irrigated with blood. Low-frequency ultrasound can promote this effect. Researchers have developed the first device that permits variable control of the ultrasound frequency.
Article

Adipose-Derived Stem Cells Show Promise in Breast Reconstruction
Cytori Therapeutics received results from an independent, investigator-sponsored study in Japan in which adipose tissue-derived stem and regenerative cells were used for breast reconstruction following partial mastectomy.
Article

Neurologix Gene Therapy Approach to Parkinson’s Disease Granted Fast Track Designation From FDA
Neurologix, Inc. has announced that the U.S. Food and Drug Administration has granted Fast Track Designation for the company’s experimental gene transfer procedure for the treatment of advanced Parkinson’s disease.
Article

Osiris Therapeutics Receives FDA Fast Track Status for Prochymal(TM) as First-Line Treatment for Acute GvHD
Osiris Therapeutics, Inc. has announced that Prochymal(TM) has received Fast Track designation from the U.S. Food and Drug Administration, expediting development of the stem cell therapy as a first-line agent for acute Graft versus Host Disease.
Article

Osiris Therapeutics Reports Positive Results for Prochymal(TM) as a Rescue Agent in Pediatric Patients with End-Stage Graft vs. Host Disease
Complete disease resolution was achieved in 58% of children receiving Prochymal as rescue agent for severe treatment resistant GvHD, resulting in a four fold improvement in 100 day survival.
Article

Oxford BioMedica Initiates Phase I/II Trial of ProSavin(R) Gene-Based Treatment for Parkinson’s Disease
Oxford BioMedica has announced that it has initiated a Phase I/II trial of ProSavin, its novel gene-based treatment for Parkinson’s disease.
Article

Oxford Biomedica Announces Data Safety Monitoring Board Recommendation to Continue Trovax Phase III Trial in Renal Cancer
Oxford BioMedica has announced that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its second planned interim analysis. The DSMB concluded that the trial should continue as planned without modification.
Article

Umbilical Cord Blood Can Help Metabolic Disorders
Umbilical cord blood transplants, even from unrelated donors, can help save the lives of babies born with certain inherited metabolic disorders, U.S. researchers reported on Monday.
Article

Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer System
This system may be used to harvest, filter, and transfer a patient’s own adipose tissue from one part of a patient’s body to another at the point-of-care in the same surgical procedure.
Article

South Korean Officials Visit Cell Bank
South Korean officials trying to rebuild stem cell research in their country after a scandal involving a top scientist are turning to leading U.S. researchers for guidance.
Article

Face-Transplant Patient ‘Satisfied’
A French woman who two years ago became the first person to receive a face transplant has recovered with remarkably good aesthetic results and has gradually regained normal skin sensation and control of her facial muscles.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Restoration of Human Dystrophin Following Transplantation of Exon-Skipping-Engineered DMD Patient Stem Cells into Dystrophic Mice
These data demonstrate that autologous engrafting of blood or muscle-derived CD133+ cells, previously genetically modified to reexpress a functional dystrophin, represents a promising approach for duchenne muscular dystrophy.
Abstract

JOB OPPORTUNITIES

Scientist
Irvine, CA (Global Biopharmaceutical Company)
Link

Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)
Link

Quality Manager
Singapore (Singapore Cord Blood Bank)
Link

Clinical Development Research Associate
Poway, California (VetStem)
Link

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

Policy

Stem Cell Agency Denies 10 Grants, Cites Conflicts of Interest
Scrambling to deal with their second conflict-of-interest mix-up in three weeks, officials at California’s stem-cell institute said Friday that they have rejected 10 new applications for research grants because some board members wrote in support of the grants.
Article

Stem Cell Panelist Steps Aside
A state stem cell agency board member accused of violating conflict-of-interest laws has removed himself from all board activities until the state Fair Political Practices Commission rules on his case.
Article

Competition for Stem Cell Research Funding Surges
The Maryland Stem Cell Research Commission has received 127 letters of intent from researchers vying to win $23 million in state funding.
Article

Umbilical Cord Blood Bill Goes to the Governor
Hospitals and health care professionals would be required to ad vise pregnant women of the option to donate umbilical cord blood under a bill that won final legislative approval yesterday.
Article

Business

Organogenesis, Inc. Signs Memorandum of Understanding with Chinese Regenerative Medicine Company
According to the signed agreement between the two firms, the first phase of the partnership will commence immediately, and will include the commercialization and exporting of existing Organogenesis, Inc. technology—including its signature product, Apligraf(R)—in the Chinese market, and eventually throughout Asia.
Article

Millipore Corporation and Novozymes Form Strategic Alliance to Supply Animal-Free Cell Culture Supplements for Bioprocessing
The new products, to be marketed under the brand name CellPrimeTM, will be manufactured by Novozymes and sold through Millipore’s sales organization. The alliance expands the existing relationship between Millipore and Novozymes and will initially focus on developing recombinant human albumin and recombinant human transferrin.
Article

Invitrogen Exclusively Licenses Novel Click Chemistry-Based Cell Proliferation Assays from Harvard University
The license enhances Invitrogen’s growing portfolio of intellectual property surrounding click chemistry, originally developed by Nobel Laureate K. Barry Sharpless’ laboratory at The Scripps Research Institute in La Jolla, CA.
Article

BioTime, Inc. Announces the Formation of Embryome Sciences, Inc. for the Development and Commercialization of Stem Cell Technology
BioTime, Inc. has announced that it has organized a new subsidiary, Embryome Sciences, Inc. The mission of the new company is to participate in the emerging field of regenerative medicine known as “embryomics”.
Article

Lab-grown Human Organs: Companies Lack Funding to Meet Expectations
Although investors have pumped more than $4.5 billion into so-called tissue engineering companies since 1990, according to federal estimates, only a smattering of lab-made skin and cartilage products have been approved for sale.
Article

NIH

Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (R01) (PA-08-043)
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Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (R21) (PA-08-044)
Link

Reminder: All System-to-System Solutions for Electronic Grant Application Submission to NIH/AHRQ/FDA/NIOSH Must Submit to Grants.gov’s 2006 System (NOT-OD-08-020)
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Change in Name for NIH Scientific Review Staff (NOT-OD-08-021)
Link

Registration Open for 2008 NIH Regional Seminars in Program Funding and Grants Administration (NOT-OD-08-022)
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Request for Information (RFI): Defining a Research Agenda for Sickle Cell Disease and Other Hemoglobinopathies (NOT-HL-08-108)
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Centers for Evaluation of Neurodevelopmental Antibodies (CENA, U24) (RFA-NS-08-005)
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CBER

Licensed Products and Establishments List – Update
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Vaccines and Related Biological Products Advisory Committee Roster
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Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals
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Advisory Committees; Filing of Closed Meeting Reports
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Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Abstract Submission and Early Registration Deadline: January 31, 2008

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



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