Volume 7.03 | Jan 30

Volume 7.03, January 30, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Discoveries May Advance Stem Cell Therapy for Parkinson’s, Cancer Patients: Researchers at the Karolinska Institutet in Sweden discovered a “master determinant” that turns embryonic stem cells into bona fide dopamine neurons, brain cells that degenerate in those with Parkinson’s disease.


Cell Therapy Offers New Hope
The findings by researchers may lead to improved stem cell therapies for patients with compromised immune systems due to intensive cancer therapy or autoimmune disease.

Universities Team Up to Pursue Stem Cell Research
Just weeks after the discovery that South Korean scientist Hwang Woo-suk forged what would have been influential stem cell research data, Yale announced it will join forces with Wesleyan University and the University of Connecticut in an attempt to push the science of stem cells forward and restore any lost credibility to the field.

Researchers Identify Major Source Of Muscle Repair Cells
In a surprising discovery with implications for treating muscular dystrophy, researchers at the University of Utah School of Medicine and other institutions have identified a major source of origin for two groups of adult cells that regulate muscle repair.

Developing Non-invasive Technique To Detect Transplant Rejection At Cellular Level
Carnegie Mellon University scientist Chien Ho and his colleagues have developed a promising tool that uses magnetic resonance imaging (MRI) to track immune cells as they infiltrate a transplanted heart in the early stages of organ rejection.

South Korean Cloning Expert’s Stem Cells Do Not Exist
Prosecutors confirmed that cloning expert Hwang Woo-Suk had fabricated key research, raising the likelihood that criminal charges could be filed against the disgraced South Korea scientist.

Bulgaria Breaks New Ground for Cancer Vaccine Testing
Bulgaria will become the first European country to hold clinical studies of an anti-cancer vaccine by Dr. Kenichiro Hasumi, a physician specialized in cancer immunotherapy and terminal care.

Allergy Cell Holds Treatment Hope
Scientists say they have found how a cell involved in allergy is made, which may help with finding new treatments.

A Little Telomerase Just Isn’t Enough, Geneticists Find
With seed money from the Johns Hopkins Institute for Cell Engineering, a Johns Hopkins geneticist and her team have discovered a critical link between the health of stem cells and the length of the chromosome ends within them.

Procedure Allows Women to Freeze Eggs to Preserve Future Fertility
Researchers at the Yale Fertility Center are now offering a cutting edge reproductive procedure called oocyte cryopreservation that allows women to freeze their eggs and use them at a later time to conceive a child.

Carbon Nanotubes that Detect Disease-causing Mutations Developed by Pittsburgh Researcher
University of Pittsburgh researcher Alexander Star and colleagues at California-based company Nanomix, Inc., have developed devices made of carbon nanotubes that can find mutations in genes causing hereditary diseases, they report in the Jan. 16 issue of the journal Proceedings of the National Academy of Science.

Clinical Research Organizations Expand Speed and Capacity of Pharmaceuticals’ Product Development Pipeline, Tufts Study Finds
The proportion of resources involved in pharmaceutical product development has shifted from drug and biotechnology companies to contract Clinical Research Organizations (CROs) over the last five years, according to a survey by the Tufts Center for the Study of Drug Development.


Identification of Intrinsic Determinants of Midbrain Dopamine Neurons
These data establish that Lmx1a and Msx1 are critical intrinsic dopamine-neuron determinants in vivo and suggest that they may be essential tools in cell replacement strategies in Parkinson’s disease.

Signals from the Sympathetic Nervous System Regulate Hematopoietic Stem Cell Egress from Bone Marrow
These results indicate that the sympathetic nervous system regulates the attraction of stem cells to their niche.


Senator Schumer Introducing Legislation To Regulate Tissue Transplants, USA
Sen. Charles Schumer (D-N.Y.) on Monday announced that he is proposing legislation that would regulate tissue transplants and donations.

Watchdog Suggests Stem Cell Policies for California
A taxpayer watchdog group is expected to release a report today (Jan. 23) outlining how leaders of the state’s $3 billion stem cell initiative could develop policies to make stem-cell-based therapies affordable and accessible to Californians.

Thailand Plans Systematic Stem Cell Research
Thailand sets up a national committee to build underlying framework for the kingdom’s systematic study of factors concerning research and development of stem cell applications to prevent exploitation from foreign firms.

New Dehli Government to Act Against Clinic Using Stem Cell Therapy
The Government has ordered an inquiry into the activities of a fertility clinic conducting embryonic stem cell therapy and warned of stringent action against those found violating the rules and guilty of playing with the health of unsuspecting patients, Health Minister Anbumani Ramadoss said.


BrainStorm Files Patent Application for Stem Cell Procedure with Potential for Multiple Sclerosis Therapy
BrainStorm Cell Therapeutics (OTCBB:BCLI), the developer of NurOwn(TM) bone marrow derived stem cell therapeutic products for the treatment of neurodegenerative diseases, announced today that a patent application has been filed with the US Patent and Trademark Office for a new procedure to derive oligodendrocyte-like cells.

Cytori Therapeutics Receives CE Mark for the Celution™ Stem Cell System; Achieves Condition for $11.0 Million Milestone Payment from Olympus Collaboration
This approval is the first CE Mark given for a device that can process adult stem cells from adipose (fat) tissue.

Geron Announces Improved Production Method for Human Embryonic Stem Cell-Derived Islet Cells
Geron Corporation (Nasdaq:GERN) announced today the presentation of a new production protocol to differentiate islet cells from human embryonic stem cells (hESCs) for the treatment of diabetes.

Amgen and Genentech Sign License Agreements For Antibody Patents
Amgen (NASDAQ:AMGN) and Genentech Inc. (NYSE:DNA) today announced that they have entered into license agreements granting licenses to each other under multiple patents relating to the manufacture and use of antibodies and related technology.

Amgen to Make Significant Investment in Manufacturing, R&D and Commercial Operations Expansion
Amgen (Nasdaq: AMGN), the world’s largest biotechnology company, today announced that it anticipates significant investment in additional manufacturing and R&D operations in the United States and Europe and expansion of its commercial operations into new markets.

Becton Dickinson Studies Stem Cell Market
U.S. medical products company Becton Dickinson and Co. (BDX.N: Quote, Profile, Research) has started to explore the commercial potential of stem cells as a treatment for diabetes, its chief executive said on Wednesday.

ReNeuron Receives Notice of Allowance from US Patent Office for Neural Stem Cell Transplantation Patent Application
ReNeuron Group plc (LSE: RENE.L) today announced that it has received a Notice of Allowance from the US Patent and Trademark Office concerning a key patent application for methods of transplantation of neural stem cells.

Medistem Reports Novel Method of Immunomodulation Through Genetic Reprogramming of Immune Cells Medistem Laboratories, Inc. (OTCBB:MDSM), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, announced today the successful development of a novel method of immune response modification utilizing a genetic reprogramming technology involving RNA interference.

Weizmann Institute Scientists Suggest that Immune Cells Help to Maintain Cognition and Brain Cell Renewal
A team of scientists at the Weizmann Institute of Science, led by Prof. Michal Schwartz of the Neurobiology Department, has come up with new findings that may have implications in delaying and slowing down deterioration of memory and learning ability in old age.

Targeted Genetics Corporation (TGEN) Strengthens Intellectual Property For AAV Vector Manufacturing Purification Processes
Targeted Genetics Corporation (Nasdaq:TGEN) today announced the issuance of an additional patent related to its adeno-associated virus (AAV) vector manufacturing processes. U.S. patent #6,989,264 is titled, “Methods for generating high titer helper-free preparation of released recombinant AAV vectors.”

Shareholders of Inex Pharmaceuticals Approve Spin Out of Targeted Immunotherapy Assets
Inex Pharmaceuticals Corporation (“INEX”;TSX: IEX) announced that at its Special Meeting of Shareholders held today, shareholders of INEX approved the Plan of Arrangement to complete the spin-out of INEX’s Targeted Immunotherapy assets into a new company, Tekmira Pharmaceuticals Corporation (“Tekmira”) with 98.3% of shares cast voting in favour of the spin-out.

FDA Blasts Boston Scientific Over cGMP Violations
The FDA is putting Boston Scientific on notice that the company’s quality management practices are insufficient, with “serious regulatory problems” being found at numerous facilities.

MicroIslet Appoints Dr. James R. Gavin III Interim President and CEO
MicroIslet, Inc. (Amex: MII) today announced that it has appointed James R. Gavin III, M.D., Ph.D., as its interim President and CEO, effective January 20, 2006. Dr. Gavin has been a member of MicroIslet’s Board of Directors since March 2001.



Application of Emerging Technologies for Cancer Research (SBIR[R43/R44]) (RFA-CA-07-008)

Application of Emerging Technologies for Cancer Research (STTR[R41/R42])(RFA-CA-07-009)


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

Cellular, Tissue and Gene Therapies Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee

Ninth Annual FDA and the Changing Paradigm for Blood Regulation Workshop – Slide Presentation


Food & Drug Administration (United States of America)

Cellular, Tissue and Gene Therapies Advisory Committee: Nature and Basis Statements of Conflict(s) of Interest for Voting Members of FDA Advisory Committee Members

Oncologic Drugs Advisory Committee; Amendment of Notice


ISCT2006. May 4-7. Berlin.
Click here for the Call for Abstracts and preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA

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