Volume 8.12 | Apr 2

Volume 8.12, April 2, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Dendreon Announces FDA Advisory Committee Reviewed Provenge(R) for Hormone Refractory Prostate Cancer: Dendreon Corporation has announced that the U.S. Food and Drug Administration’s (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of PROVENGE (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.

Osiris Therapeutics Announces Positive Results in Groundbreaking Stem Cell Trial to Treat Heart Disease: Intravenous therapy resulted in statistically significant improvement over placebo in multiple safety and efficacy endpoints.


Dental Enamel Grown From Cultured Cells
A Japanese team say’s they’ve used cultured cells to grow new tooth enamel.

Engineering the Heart Piece by Piece
University of Michigan scientists see great promise in cardiac tissue engineering, but hurdles remain before lab-grown muscle is ready for patients

Ultrathin Films Deliver DNA as Possible Gene Therapy Tool
Researchers have created ultrathin, nanoscale films composed of DNA and water-soluble polymers that allow controlled release of DNA from surfaces.

DNA Layer Reduces Risk Of Reserve Parts Being Rejected
Dutch researchers have given body implants a DNA layer that ensures a better attachment, more rapid recovery of the surrounding tissue and less immune responses.

Immune Response to Cancer Stem Cells May Dictate Cancer’s Course
A new study by Rockefeller University scientists shows that immunity to cancer stem cells may help protect people with a precancerous condition from developing the full-blown disease, and that these cells could be an important target for cancer vaccines.

Hopkins Researchers Develop Novel X-Ray System for Tracking the Delivery and Distribution of Stem Cells
In a first of its kind study, researchers at Johns Hopkins Medicine have developed a new technique that transports therapeutic stem cells in a multilayer microcapsule that not only protects the cells from being attacked by the body’s immune system but also enables them to be seen on X-ray.

Stem Cell Therapy Shows Promise for Rescuing Deteriorating Vision
In a study in rats, neural progenitor cells derived from human fetal stem cells have been shown to protect the vision of animals with degenerative eye disease similar to the kinds of diseases that afflict humans.

FDA Submission Filed for Clinical Trial of Stem Cells in Heart Attack Patients
Australia’s adult stem cell company, Mesoblast Limited has announced that its US-based sister company, Angioblast Systems Inc., had filed an Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA) to commence a Phase 2 clinical trial of its allogeneic, or ‘off-the- shelf’, adult stem cells in patients with heart attacks.

University of Alabama at Birmingham to Lead Pioneering Cancer Trial
Ovarian cancer patients in the study to be treated with a tumor-killing virus.

Stem Cell Technique Speeds Liver Regeneration
Using adult bone marrow stem cells, scientists say they have been able to regenerate human liver tissue.

Muscle Stem Cells May Offer A New Treatment Option For Congestive Heart Failure
Scientists have performed the first U.S. controlled, randomized Phase I clinical trial using a three-dimensional guided catheter system to deliver muscular stem cells to the heart.

Dolly Cloner Offers Sad Tale
Ian Wilmut, in Hartford for the StemCONN 07 international stem cell conference, talked about why over the last 10 years he and other scientists have not been able to accomplish the same feat with human cells.

Korean Team Claims to Have Cloned Wolves
A Seoul National University team has said that it successfully cloned two female wolves in October 2005 for the first time in the world.

Thinking Outside the Egg, Scientists Propose Interspecies Cloning
At least three respected teams of British scientists have reignited the moral debate over inserting human genes into animal eggs by proposing similar experiments to Cibelli’s.

University of Florida Launches Project to Bridge ‘Regeneration’ Gap
Researchers at the McKnight Brain Institute of the University of Florida have initiated a project to treat human brain and other diseases by plundering the secrets of regeneration from creatures with remarkable powers of self-renewal, such as salamanders, newts, starfish and flatworms.


Clinical Xenotransplantation of Organs: Why Aren’t We There Yet?
This article discusses the history, current status, and challenges of xenotransplanation.


More Institutions Developing Stem Cell Research Ethics Oversight, Survey Shows
In the first attempt to track ethical oversight activity among U.S. research institutions engaged in human embryonic stem cell research, a survey done by UConn’s Office of Embryonic Stem Cell Research Oversight (ESCRO) finds that a majority have, or plan to establish, special ethics review panels for this research.

EU to Register Human Embryonic Stem Cell Lines
The European Commission has agreed on funding for the creation of a European registry for human embryonic stem cell lines.

Ban on Private Cord Blood Centres in Dubai Likely
“Two private cord blood centres were recently shut down by the Department of Health and Medical Services as part of the government’s plan to ban all such centres operating in the country,” said an official, adding that other such centres will also face the axe soon.

New Australian Cloning Laws ‘Stem the Brain Drain’
Australia’s new therapeutic cloning laws will help stem the brain drain of top scientists heading overseas, one of the nation’s top legal ethicists says.

Missouri House Committee Advances Anti-stem Cell Measure
Opponents of embryonic stem cell research Tuesday forced through a House committee a proposed constitutional change that would undo research protections, seizing an opportunity when a supporter of embryonic research was absent.

Governor Wants End to Curb on Stem Cells in Boston
Governor Deval Patrick will announce this morning that he wants the Department of Public Health to reverse restrictions on stem cell research imposed by his predecessor, according to an administration official with direct knowledge of the governor’s intentions.

Competing Stem Cell Bills Get Committee Pass in Florida
A Senate panel rushed for time passed two contradictory stem cell bills Tuesday that would alternately prohibit and allow $20 million in state funding to be used for embryonic stem cell research.


Oxford BioMedica, Sanofi-Aventis Enter Development Agreement for Cancer Treatment
Oxford BioMedica PLC, a developer of gene therapy treatments, and drugmaker Sanofi-Aventis SA have said they have agreed to jointly develop and market the cancer treatment TroVax.

Stemagen, UPenn Partner to Advance Therapeutic Use of Stem Cells
Stemagen has acquired the exclusive rights to a patent for a groundbreaking technique that allows the development of embryonic stem cells appearing to have a markedly enhanced potential for therapeutic use – uniparental embryonic stem cells.

Alnylam Grants Bio-Rad License to Kreutzer-Limmer Patents for the RNA Interference (RNAi) Research Products Market
Alnylam Pharmaceuticals, Inc. has announced that it has granted Bio-Rad a non-exclusive license to provide RNAi research products under the Kreutzer-Limmer patent family. This patent family, owned exclusively by Alnylam, covers small interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells.

Plureon Corporation Receives NIH Grant
Plureon Corporation has announced it has been awarded a grant by the National Institute of Diabetes & Digestive & Kidney Diseases of the National Institutes of Health to advance the company’s platform stem cell technology in the field of diabetes. The grant provides $1 million in funding over a two-year period and may be extended after that for a total of up to $4 million.

Pluristem Upgrading Its Manufacturing Facility to Support $200 Million in Production Capacity for PLX – I
The additional 6,900 square foot will double in size the Company’s facilities and is expected to be ready this summer. This facility will manufacture PLX-I, the Company’s introductory product to address the bone marrow transplant market, for Phase I clinical trials and large scale commercial production.


Notice of Extension for Request for Information (RFI): Tools and Resources for Human Embryonic Stem Cell Research in the Nervous System (Neuroscience Blueprint) (NOT-DC-07-002)

Notice of Clarification of Application Instructions for NIH Director’s New Innovator Award (DP2) (NOT-RM-07-007)

Notice of NCRR’s intent to withdraw from Development of Nonmammalian Models and Related Biological Materials for Research (R21) (NOT-RR-07-008)

Innovations in Biomedical Computational Science and Technology (R01) (PAR-07-344)


Biological Product and HCT/P Deviation Reports – Annual Summary for FY2006

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop


Consultation Paper on the Proposed Clinical Trial Regulatory Arrangements Under ANZTPA


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