Volume 8.27 | Jul 16

Volume 8.27, July 16, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Breakthrough at New McMaster Institute Will Dramatically Change Focus for Human Stem Cell Science: Researchers of the McMaster Stem Cell and Cancer Research Institute show that human embryonic stem (ES) cells can actually produce distinctive “niche” cells, which then release stem-cell nourishing proteins to help keep their ‘parents’ ticking over.

World’s First Therapeutic Vaccine for Brain Cancer Commercially Available to Patients in Switzerland: Northwest Biotherapeutics, Inc. is pleased to announce that it has received Authorization for Use from the Swiss Institute of Public Health to make DCVax(R)-Brain commercially available for treatment of brain cancer patients in Switzerland.


Scientists Establish Essential Markers to Characterize Human Embryonic Stem Cell Lines
Scientists with the International Stem Cell Initiative have identified a set of common gene expression markers that may be used to reliably characterize diverse human embryonic stem cell lines.

Skin Cells ‘Fight Child Cancer’
Genetically modified skin cells could be used to fight a cancer which strikes the very young.

Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial
A molecularly engineered therapy selectively embeds a gene in pancreatic cancer that shrinks or eradicates tumors, inhibits metastasis, and prolongs survival with virtually no toxicity.

First Lung Transplants in Mice Lay Groundwork for New Drugs to Prevent Transplant Rejection in Humans
Surgeons at Washington University School of Medicine in St. Louis have developed the first mouse model of lung transplantation, and they’re hoping it will help explain why the success of the procedure in humans lags far behind other solid organ transplants.

Beike Biotechnology Study Suggests Adult Stem Cells Show Promise For Peripheral Vascular Disease
Beike Biotechnology Co., Ltd. has announced that a team led by Dr. Yang Xiaofeng at its collaborating hospital in Shenyang completed a study to assess clinical efficacy, safety, and feasibility of transplantation of peripheral blood stem cells for patients with peripheral vascular disease of the lower extremities.

Mesoblast Moves Forward with the Next Phase of Clinical Trials Using “Off-the-Shelf” Stem Cells
Mesoblast Limited has announced the commencement of its first United States-based clinical trial using allogeneic, “off-the-shelf” or universal donor, adult stem cells for patients with intervertebral disc disease and requiring spinal fusion.

Stem Cell Clinical Trials to Begin at Wahlen VA Medical Center
Red tape has held up the work since 2004, but now stem cell researchers at the University of Utah say they are ready to begin clinical trials for a new stem cell therapy at the veterans’ hospital in Salt Lake City.

Injecting Autologous Cells Could Relieve Urinary Incontinence
Transurethral injections of autologous myoblasts and fibroblasts could relieve stress urinary incontinence in women, conclude authors of an article published in The Lancet.

Aldagen Adds Three Clinical Sites to its Critical Limb Ischemia Study
The three additional sites are Duke University Medical Center (Durham, NC), Indiana University (Indianapolis, IN) and Saint Joseph’s Research Institute (Atlanta, GA).

Cell Genesys Completes Patient Recruitment for First Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
Cell Genesys, Inc. has announced that it has completed recruitment of over 600 patients into VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer.

ViaCell Receives IDE Supplement Approval to Advance ViaCyte Pivotal Trial
ViaCell, Inc. has announced that it has received FDA approval of its investigational device exemption supplement for its ViaCyteSM pivotal clinical trial.

South Korean Lab Looks at Cloning Drug-sniffing Dogs
A South Korean laboratory that produced the world’s first cloned dogs is looking to get into the business of cloning canines, first by cloning drug-sniffing dogs.


Stem Cell Therapy for Autism
In this article, researchers propose that the combined use of MSC and cord blood CD34+cells may be useful in the treatment of autism.


Waxman, Kennedy Seek Papers on U.S. Surgeon General
Representative Henry Waxman and Senator Edward Kennedy asked the U.S. health department to produce documents related to claims the former surgeon general was blocked from speaking on stem cells and other politically sensitive issues.

Brownback Splits the Difference On Stem Cell Research
Senator Sam Brownback recently voted in committee against the fiscal 2008 spending bill for Labor, Health and Education because it includes a provision that would expand federal funding for embryonic stem cell research. But he did get a $500,000 earmark added to the bill (S 1710) for the Midwest Institute for Comparative Stem Cell Biology.


Pluristem and Center for Regenerative Therapies at Charité University Hospital of Berlin Enters into Collaborative Research Agreement
Pluristem and BCRT will collaborate on a variety of indications utilizing mesenchymal stem cells (MSCs) derived from the placenta that have been expanded in the Company’s proprietary PluriX(TM) 3-D bioreactor.

Roche and Alnylam Form Major Alliance on RNAi Therapeutics
Roche and the US-based biopharmaceutical company Alnylam Pharmaceuticals, Inc. have announced that they have entered into a major alliance in which Roche obtains a non-exclusive license to Alnylam’s technology platform for developing RNAi therapeutics.

5W Public Relations to Represent BrainStorm Cell Therapeutics
5W Public Relations has announced that BrainStorm Cell Therapeutics Inc. has hired the firm as its PR agency of record.

Dendreon’s New Headache
Getting its cancer drug Provenge to market is not the only thing Dendreon has to worry about. You can add the U.S. Securities and Exchange Commission to the list.

Bioheart Boosts Expected Size of IPO
Biotechnology company Bioheart Inc. boosted the anticipated size of its proposed initial public offering, according to a regulatory filing with the Securities and Exchange Commission.

Cloning Pioneer Alan Colman to Lead Singapore Stem Cell Institute
Alan Colman, the scientist who helped clone Dolly the sheep more than a decade ago, said he would return to a laboratory-based role as the head of a Singapore government body responsible for stem cell research.

StemCyte Appoints Robert Dickey IV as Senior Vice President and Chief Financial Officer
StemCyte, Inc. has announced the appointment of Robert Dickey IV as Senior Vice President and Chief Financial Officer.

ViaCell Wins Federal Circuit Patent Appeal
ViaCell, Inc. has announced that the U.S. Court of Appeals for the Federal Circuit has ruled in favor of ViaCell in a patent infringement suit brought against the Company and other defendants by PharmaStem Therapeutics, Inc.


The NIH Intramural Research Program and the NIH Director’s Roadmap Initiative – Locus of Review (NOT-RM-07-011)

Transfusion-Related Acute Lung Injury (TRALI) Basic Research (R01) (PA-07-385)

NIH Announces New Resource for Advancing Innovative Technologies Toward Commercialization The National Institutes of Health (NIH) launched today a new Web-based resource called NIH Pipeline to Partnerships (P2P), aimed at furthering the development of NIH’s licensed technologies and technologies funded through the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.


Questions and Answers Concerning the June 19, 2007 Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling

Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

Fast Track Designation Request Performance – Updated

Approved Biological NDA and ANDA Applications – Update

Recall of CS3000 Apheresis Kits (Fenwal, Inc.)



Stem Cell Research Planning Begins
The Department of Health has been instructed to begin work on the development of an appropriate regulatory framework for stem cell research.


7th Annual Somatic Cell Therapy Symposium
September 26-28, 2007
Hyatt Regency Bethesda, Maryland

Registration now open!  Click here to register.

ISCT Membership
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