Volume 7.40 | Oct 16

Volume 7.40, October 16, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Ceregene, Inc. Announces Promising Phase 1 Results From Gene Therapy Trial For Parkinson’s Disease: Ceregene, Inc. announced today that CERE-120, a gene therapy product in development for the treatment of Parkinson’s disease, was well tolerated and appeared to reduce symptoms by approximately 40%.

Isolagen, Inc. And FDA Reach Agreement On Phase III Protocol Design: Isolagen, Inc. has announced that the Company has reached an agreement with the Food and Drug Administration (FDA) on the design of its Phase III pivotal study protocol for the use of Isolagen(TM) Therapy for the treatment of wrinkles.


Breast Cancer Findings Suggest New Ways To Detect And Destroy Cells Before They Become Cancerous
New UC Davis research supports the recent hypothesis that both ductal carcinoma in situ and invasive breast cancer develop from the same breast cancer progenitor cells.

Gene Therapy for Inherited Childhood Blindness Tested in Mice
Researchers from Switzerland describe the results in mice of a possible gene therapy treatment for one inherited childhood blindness-a variant of Leber congenital amaurosis-which is caused by mutations in a gene active in the retina, retinal pigment epithelium-specific protein, 65 kDa (RPE65).

University Of Pittsburgh Is Investigating The Potential For Adult Stem Cells To Repair Hearts Damaged By Severe Coronary Artery Disease
The University of Pittsburgh School of Medicine today announced that it is one of the first medical centers in the country participating in a novel clinical trial to study if a patient’s own stem cells can treat a form of severe coronary artery disease.

Isolagen, Inc. and FDA Reach Agreement On Phase III Protocol Design
Isolagen, Inc. has announced that the Company has reached an agreement with the Food and Drug Administration (FDA) on the design of its Phase III pivotal study protocol for the use of Isolagen(TM) Therapy for the treatment of wrinkles.

Osiris Therapeutics Receives Approval from Health Canada to Conduct Phase III Clinical Trial for Lead Stem Cell Drug
Osiris Therapeutics, Inc. has received regulatory approval to expand patient enrollment into Canada for its ongoing Phase III pivotal trial evaluating PROCHYMAL™ for the treatment of Graft vs. Host Disease.

Accentia Biopharmaceuticals Majority-Owned Subsidiary Receives Rare Disease Designation from European Drug Agency for Follicular non-Hodgkin”s Lymphoma
Biovest International, Inc. has received notification from the Commission of the European Union on its acceptance of Biovest’s BiovaxID™ therapy for Follicular Lymphoma for entry into the European Community’s Drug Register for Rare Diseases.

Avax Technologies Announces Special Protocol Assessment Agreement with FDA for a Phase III Clinical Trial of M-Vax in Metastatic Melanoma
Avax Technologies, Inc. announced it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the initiation of a registrable pivotal Phase III clinical trial for M-Vax, the Company’s AC Vaccine technology for the treatment of patients with metastatic melanoma.

Fetal Surgeries of the Future
Treating the patient with stem cells even before they are born could prevent some adult diseases, like diabetes or sickle cell anemia.


Lentiviral Expression of Retinal Guanylate Cyclase-1 (RetGC1) Restores Vision in an Avian Model of Childhood Blindness
Blindness associated with loss of function of retGC1 in the GUCY1*B avian model of LCA1 can be reversed using viral vector-mediated gene transfer. Furthermore, this reversal can be achieved by restoring function to a relatively low percentage of retinal photoreceptors.


Stem Cell Research Splits State Candidates
Voters could decide whether Minnesota funds local scientists’ work with embryos.

Australian Stem Cell Centre Signals Stand Against ‘Chimera’
The Australian Stem Cell Centre has distanced itself from a recommendation to legalise a controversial technique that merges animal eggs and human cells in a surprise move designed to clear the path to therapeutic cloning.

Australia Defends Support of Embryonic Stem Cell Research
The federal government has defended the taxpayer-funded research being conducted using surplus embryonic stem cells obtained from IVF procedures.


StemSoft Software Launches New Corporate Website
The resource-focused website provides tools and information for the medical specialties.


Two Industry Leaders Join Progenitor Cell Therapy Board
Progenitor Cell Therapy, LLC (PCT) announced today that Mr. Robert Hamm and Professor K.K. Jain have both agreed to join its Board of Managers and that a majority vote of the Members has formally approved both appointments.

Aldagen, Inc. And Innovative Micro Technology Form Regenerative Medicine Alliance To Develop Revolutionary Stem Cell Purification System
Aldagen, Inc. and Innovative Micro Technology (IMT) today announced that they have formed an alliance to co-develop and commercialize a version of IMT’s Rare Cell Purification System, customized specifically for clinical cell therapies.

Massachusetts Eye and Ear Infirmary (MEEI) To Evaluate Stem Cell Innovations’ PluriCells(TM) For Hearing Research
Under the material transfer agreement, MEEI will evaluate PluriCells™ for their capacity to form the human tissues implicated in hearing loss. In return SCI will receive a nonexclusive license to intellectual property generated using the PluriCells.

Healtheuniverse Announces Expansion of International Research and Development Center to Further Stem Cell Applications, Clinical Trials, and Product Line Commercialization
Healtheuniverse, Inc. has announced the incorporation of its new wholly owned subsidiary in Singapore, Healtheuniverse Pte Ltd.

First Quantum Grant to Fund Stem Cell Repair of Damage from Stroke
The National Institutes of Health has named researchers at Baylor College of Medicine (BCM) and Rice University in Houston as the first and only recipients of the inaugural Quantum Grant for their international research initiative to regenerate damaged brain cells and blood vessels for the treatment of stroke.

Stem Cell Products, Inc. Receives Grants from State of Wisconsin
Stem Cell Products, Inc. has announced that the Wisconsin Department of Commerce has awarded the company $1,000,000 in technology development grants and loans.

DomaniCell Obtains Stem Cell Banking License
DomaniCell, LLC announced today it has obtained a license to perform umbilical cord blood collection, processing, and storage from the New Jersey Department of Health and Senior Services.

MultiCell Technologies Announces Milestone Patent Issued by European Patent Office on Treatments for Autoimmune Diseases
This patent covers the company’s immune-based therapeutics to target MS, diabetes and other unmet medical needs.

Lawsuits Allege Fraud and Negligence in Stem Cell Treatment
The Kansas City Blood and Marrow Transplant Program has been sued by 17 former patients and their survivors, who say the program failed to ensure stem cells given to patients were in good condition.

Dead Cats to Remain a Memory
Genetic Savings & Clone, a biotechnology company that sold cloned pets, sent letters to its customers last month informing them it will close at the end of the year because of little demand for cloned cats.


2007 NIH Director’s Pioneer Award Program (DP1) (RFA-RM-07-005)


Current Licensed Establishments and Products – Update

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


Food and Drug Administration (United States of America)

Vaccines and Related Biological Products Advisory Committee


International Society for Cellular Therapy – http://www.celltherapysociety.org

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 4 / August 2006

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.

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