Volume 9.08 | Mar 3

Cell Therapy News 9.08, March 3, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Prochymal(TM) Demonstrates Lasting Benefit in Heart Attack Patients; Osiris Receives FDA Clearance to Start Phase II Trial: Osiris Therapeutics, Inc. has announced that interim results at the one year time point for the Company’s Phase I trial evaluating Prochymal(TM) for the treatment of heart attack patients continued to demonstrate a strong safety profile and statistically significant improvement in heart function. Based upon the positive results from this 53-patient, double-blind, placebo-controlled trial, the Company has received approval from the Food and Drug Administration to initiate a Phase II trial.


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Building Brains: Mammalian-like Neurogenesis In Fruit Flies
A new way of generating brain cells has been uncovered in Drosophila.

Safer Stem Cells?
A small California biotech company backed by billionaire John Tu claims to have created stem cells without destroying human embryos or introducing cancer-causing genes, in what could be a major step toward using these stem cells for human trials.

Stem Cell-based Therapy May Be Able To Treat Muscular Dystrophy
A new way to manipulate embryonic stem cells offers hope for an eventual cell-based therapy to treat muscular dystrophies.

Yale Scientists Create Artificial ‘Cells’ that Boost the Immune Response to Cancer
Using artificial cell-like particles, Yale biomedical engineers have devised a rapid and efficient way to produce a 45-fold enhancement of T cell activation and expansion, an immune response important for a patient’s ability to fight cancer and infectious diseases.

RNA Interference Shows Effectiveness In Treating Humans
RNA interference recorded what appears to be the first significant demonstration of an effect in people.

Stem Cell Trial Offers Hope for Patients with Severe Ischemic Heart Disease
Patients with ischemic heart disease, a serious condition that occurs when the heart’s arteries become clogged with cholesterol plaque, may have new options if they have exhausted traditional cardiovascular therapies.

Vaccinogen’s New Anti-Cancer Vaccine Commercially Available in Europe This Year
Vaccinogen, Inc. announced that its new vaccine to block colon cancer from recurring will be commercially available in Europe starting June 2008.

Adult Stem Cells Help Those With Immune Disorders, Heart Disease
Treatment with adult stem cells harvested from blood or bone marrow may benefit some patients with certain kinds of cardiovascular disorders and autoimmune diseases, a new U.S. analysis shows.


Clinical Applications of Blood-Derived and Marrow-Derived Stem Cells for Nonmalignant Diseases
This article summarizes new, nonmalignant, nonhematologic clinical indications for use of blood- and bone marrow–derived stem cells.

Hematopoiesis: An Evolving Paradigm for Stem Cell Biology
This review describes the developmental origins of HSCs and the molecular mechanisms that regulate lineage-specific differentiation.


Cell Therapy Business Development Leader
Portland, OR (Invitrogen)


Stem Cells: A Sure Bet in the ’08 Race
Whoever wins the White House, stem cell biotechs stand to reap the benefit from an incoming leader who is friendlier to stem cell researchers than President Bush, and that could lift stocks for the entire sector, experts say.

California Snags Another Half Billion for Stem Cell Labs
California’s young stem cell agency has extracted promises of nearly $500 million in matching funds to help build what it calls one of the most ambitious medical-science lab-construction programs in the nation’s history.

Life Sciences Bill Gets Booster Shot in Massachusetts House
A plan to invest $1 billion over 10 years in the life sciences industry, which employs thousands of people in the Merrimack Valley, Cape Ann and the North Shore, received initial approval from the Massachusetts House late last night.

Japan Government Set to Launch Stem Cell Project at Four Institutions
The Education, Science and Technology Ministry will launch a research project in April involving four research institutions to study induced pluripotent stem cells, which have the potential to grow into any type of human cells, in an effort to ensure iPS cells can be used in regenerative medicine as soon as possible, the ministry said Friday.

600k to Promote UK Stem Cell Research
The Medical Research Council and the Biotechnology and Biosciences Research Council are calling for proposals from current MRC and BBRC grant holders, working on human stem cells research, for pump-priming activities to promote the development of human-induced Pluripotent Stem cells.


Organogenesis Acquires NanoMatrix
Organogenesis Inc. said Monday the company has acquired NanoMatrix Inc. for an undisclosed amount.

Regeneration Technologies, Tutogen Medical Merger Completed
Regeneration Technologies, Inc. and Tutogen Medical, Inc. have announced that the merger of the two companies is completed. The merger was approved by the shareholders of both Regeneration Technologies and Tutogen Medical at separate special shareholder meetings. The total value of the transaction is approximately $205 million.

Stem Cell Therapy International Signs Memorandum of Intent to Merge With a Leading Umbilical Cord Stem Cell Company Histostem, Co., Ltd. of Korea
On February 27, 2008, Calvin Cao, CEO and President of Stem Cell Therapy International, Inc. and Dr. Han Hoon, CEO and President of Histostem, Co., Ltd., of Korea jointly announced the signing of a Memorandum of Understanding for their companies to merge subject to further discussions with respect to operational details and the signing of the definitive agreement.

Living Cell Technologies and US- Based Barbara Davis Center to collaborate on Diabetes Clinical Trial Program
Living Cell Technologies Limited has announced that the Company has signed a term sheet with the Barbara Davis Center for Childhood Diabetes to establish a diabetes clinical trial program in Denver, Colorado.

International Stem Cell Corporation’s Human Parthenogenetic Stem Cells to be used in Germany in the Development of Treatments for Neural Disease
The work will be headed by Dr. Albrecht Mueller of the University of Wuerzburg, Wuerzburg, Germany under a Material Transfer Agreement between International Stem Cell Corporation and the University of Wuerzburg.

Advanced Cell Technology, Inc. Enters into License Agreement with Pharming Group N.V.
Advanced Cell Technology, Inc. has announced that it has entered into an agreement with Pharming Group N.V. giving Pharming an exclusive, global license to non-human use of certain patents associated with but not limited to oocyte activation patents held by Advanced Cell Technology.

ThermoGenesis Subsidiary Vantus Announces Stem Cell Agreement With UC Davis Center For Equine Health
Under the agreement, the two organizations will conduct joint research and development of methods to enhance the collecting, processing and storing of stem cells from equine cord blood, bone marrow and placental tissue.

ReachBio Partners with Axiogenesis to Distribute Novel Cell-Based Products in North America
The agreement gives ReachBio exclusive North American distribution rights to pure cardiomyocytes and other novel ES cell-derived products for drug discovery, toxicity testing, and R&D applications.

Two Cord Blood Banks Opened to Public
Two human umbilical cord blood banks in the cities of Beijing and Tianjin have received the authorization from the Ministry of Health and opened to the public.

U.S. Patent Office Upholds Key Human Embryonic Stem Cell Patent
Geron Corporation has announced that the U.S. Patent Office has upheld the validity of a key patent for human embryonic stem cells. The patent is assigned to the Wisconsin Alumni Foundation (“WARF”) and is one of three related patents challenged through reexamination proceedings.

Americans for Cures Foundation Announces Michael J. Fox as Keynote Speaker at April Conference
Americans for Cures Foundation announces Michael J. Fox as a featured speaker at State of Stem Cell Advocacy 2008, this year’s leading conference for grassroots advocates supporting stem cell research.

Osiris Therapeutics Strengthens Management Team
Osiris Therapeutics, Inc. has announced the addition Dr. Jeffry Lawrence, M.D. as Executive Medical Director and Dr. Jesus Soriano M.D., Ph.D. as Senior Director of Business Development.

Stem Cell Company t2cure Appoints Dr Rueck Head of Clinical Operations
t2cure has announced that it has appointed Dr. Petra Rueck Head of Clinical Operations.


Guidance on NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (PHRP) (NOT-OD-08-054)

Cooperative Centers for Translational Research on Human Immunology and Biodefense (U19) (RFA-AI-08-014)



FDA Consumer Updates: FDA 101: Human Gene Therapy

Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases – Update

CBER Organizational Information – Update



White House Wants to Widen FDA Authority Over Imports
Health and Human Services Secretary Mike Leavitt said the Bush administration supports legislation giving the Food and Drug Administration explicit authority over unsafe food or drugs made overseas with the intent of shipping them to the U.S.

FDA Unveils Plan to Boost Oversight of Drugs Once They Are on Market
The Food and Drug Administration unveiled a new effort to bolster its oversight of drugs after they’re on the market, in the agency’s latest response to years of criticism about its handling of medication safety issues.


Conference Info: Contract Good Manufacturing Practice (GMP) Quality Control (QC) Labs Symposium


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

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

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