Volume 9.10 | Mar 17

Cell Therapy News 9.10, March 17, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

FDA Agrees to Amend Dendreon’s Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE: The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study’s interim and final results.
Article

Genitope Corporation to Suspend Development of MyVax(R) Personalized Immunotherapy: Genitope Corporation has announced that, based on a meeting with representatives of the U.S. Food and Drug Administration to discuss the previously announced results of Genitope’s pivotal Phase 3 clinical trial of MyVax(R) personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL) patients, Genitope intends to suspend development of MyVax(R) personalized immunotherapy.
Article

Science

VIDEO: Shrinky-Dink Hanging Drops: A Simple Way to Form and Culture Embryoid Bodies
This video outlines the protocols for the most common method of creating embryoid body aggregates; using the hanging drop method.
Link

On A ‘Roll’: Researchers Devise New Cell-sorting System
Capitalizing on a cell’s ability to roll along a surface, MIT researchers have developed a simple, inexpensive system to sort different kinds of cells – a process that could result in low-cost tools to test for diseases such as cancer, even in remote locations.
Article

Researchers Control Growth Rate of Replacement Blood Vessels, Tissues
Researchers have discovered a way to control the growth rate of replacement tissue and the formation of new blood vessels, which solves one of the vexing problems of growing replacement tissue to treat injuries and trauma in humans.
Article

Post Brain Injury: New Nerve Cells Originate from Neural Stem Cells
The study group of Prof. Dr. Magdalena Götz is able to show that after injury, reactive glial cells in the brains of mice restart their cell division. They then become stem cells from which nerve cells can form yet again under favourable cell culture conditions.
Article

Injection of Human Umbilical Cord Blood Helps Aging Brain
When human umbilical cord blood cells were injected into aged laboratory animals, researchers at the University of South Florida found improvements in the microenvironment of the hippocampus region of the animals’ brains and a subsequent rejuvenation of neural stem/progenitor cells.
Article

In Novel Strategy Against AIDS, Einstein Researchers Genetically Engineer Immune Cells Into Potent Weapons for Battling HIV Infection
By outfitting immune-system killer cells with a new pair of genes, scientists at the Albert Einstein College of Medicine of Yeshiva University transformed them into potent weapons that destroy cells infected with HIV, the virus that causes AIDS.
Article

Long-term Muscle Improvements Shown In Gene Therapy Study In Mice
Injecting a gene responsible for making a specific protein into a mouse that’s used as a model for muscular dystrophy can lead to long-term improvements in the animal’s muscle size and strength, a new study shows.
Article

Gene Therapy Could Save Kids From A Lifetime Of Eating Cornstarch
A gene therapy treatment that restores a missing liver enzyme in test animals could provide a cure for a rare metabolic disorder in humans, according to Duke University Medical Center researchers.
Article

Gene Therapy Success Raises Hope of Huntington’s Treatment
Scientists are a step closer to curing a severe inherited brain-wasting disease using gene therapy. The illness is in the same family as Huntington’s disease, raising hopes that a similar approach could also be effective in that case.
Article

Amazing Recovery Attributed to Cord Blood
A toddler diagnosed with cerebral palsy has shown remarkable improvement.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Characterization of Adult Prostatic Progenitor/Stem Cells Exhibiting Self-Renewal and Multilineage Differentiation
These studies are the first to report a reproducible system to assess adult prostatic progenitor/stem cells.
Abstract

Human Dental Pulp Stem Cells Improve Left Ventricular Function, Induce Angiogenesis, and Reduce Infarct Size in Rats with Acute Myocardial Infarction
This study suggests that dental pulp stem cells could provide a novel alternative cell population for cardiac repair, at least in the setting of acute myocardial infarction.
Abstract

Banking on the Future of Stem Cells
Representatives of 21 stem cell funding agencies from 19 countries – members of the International Stem Cell Forum – met in San Francisco at the end of February to discuss collaborations and how to coordinate cell banks and registries. Among them was Leszek Borysiewicz, head of the UK Medical Research Council, who spoke to Nature about the effort.
Abstract

Policy

Wide Support for Stem Cell Research in Brazil
The vast majority of people in Brazil are in favour of utilizing embryonic stem cells for scientific purposes, according to a poll by Ibope. 75 per cent of respondents completely support this practice.
Article

UK MPs Back Artificial Sperm for Childless
MPs are planning a change in the law to allow babies to be conceived from artificial sperm, a move described by opponents as playing God with human DNA.
Article

California Stem Cell Agency Raises Execs’ Top Pay Levels 23 Percent
The 29-member board of the California Institute for Regenerative Medicine, meeting at Sacramento’s Crest Theatre, approved the pay ranges unanimously after little discussion.
Article

Costs for Stem Cell Institute Home in Dispute
A highly touted agreement that won San Francisco Mayor Gavin Newsom bragging rights for landing the headquarters of California’s stem cell institute in his city three years ago has run into a snag – a dispute over how to pay potentially millions of dollars in operating expenses.
Article

Business

Advanced Cell Technology and Catholic Healthcare West Sign Clinical Agreement
Advanced Cell Technology, Inc. has announced that it has signed a clinical trial agreement with Chandler Regional Medical Center and Mercy Gilbert Medical Center, members of Catholic Healthcare West, the nation’s eighth largest healthcare system, to become ACT’s first clinical trial sites for the Phase II myoblast study.
Article

VistaGen Therapeutics Announces Broad Stem Cell R&D Alliance With Toronto’s University Health Network and The McEwen Centre For Regenerative Medicine
VistaGen Therapeutics, Inc. has announced an expansive ES cell research alliance with Toronto’s University Health Network and its stem cell research affiliate, the McEwen Centre for Regenerative Medicine.
Article

UC Berkeley and Stanford University Launch Joint Stem Cell Research
The University of California, Berkeley, and Stanford University School of Medicine will join forces in a new stem cell initiative that will catalyze research and serve as a magnet for scholars from around the world.
Article

Arrowhead Subsidiary, Calando Pharmaceuticals, Submits IND for Clinical Trial with Targeted, Nano-Delivered RNAi Therapeutic for Cancer
Arrowhead Research Corporation has announced that its majority owned subsidiary, Calando Pharmaceuticals submitted an investigational new drug application to the U.S. Food and Drug Administration to initiate a Phase I clinical trial using their lead anti-cancer compound, CALAA-01.
Article

$20 Million Arizona Venture Fund Dedicated to Biosciences
A consortium of biotechnology and investment professionals have partnered to create Arizona’s first venture capital firm dedicated to early-stage bioscience companies.
Article

Sigma-Aldrich, Oxford BioMedica and Open Biosystems Settle Patent Dispute Over Use of LentiVector Technology in Research Reagents
Oxford BioMedica and Open Biosystems, Inc. have jointly announced a confidential settlement of their patent litigation. Sigma-Aldrich and Oxford BioMedica agreed to dismiss the lawsuit brought against Open Biosystems. Open Biosystems agreed to dismiss its counterclaims in the lawsuit.
Article

Nastech Pharmaceutical Company Inc. Completes Key RNAi Patent Filings
Nastech Pharmaceutical Company Inc. has announced that it has completed filing 83 patent applications (79 international applications and 4 U.S. applications) directed toward 144 different genes with siRNA’s designed and modified using Nastech’s proprietary RNAi technologies.
Article

US Upholds Two More Stem Cell Patents
The U.S. Patent and Trademark Office has upheld a second and a third University of Wisconsin-Madison patent covering embryonic stem cell research at the school.
Article

Islet Transplantation Biologist Joins Vitro
Vitro Diagnostics, Inc., dba Vitro Biopharma, announced that Dr. Tinalyn Kupfer, formerly Technical Director of the Rocky Mountain Islet Transplant Program has joined Vitro’s scientific team that is developing stem cell-derived human pancreatic beta islets for commercial applications in research and drug development.
Article

Americans for Cures Foundation Announces Brock Reeve as Featured Speaker at April Conference
Mr. Reeve Joins Michael J. Fox and Robert N. Klein as Speakers for This Event
Article

NIH

Funding Freeze Chills Research Careers
A recent report articulates a broad concern that five years of flat funding at the NIH – which, with rising inflation, can be viewed as a funding decrease – is forcing scientists to downsize their laboratories and abandon innovation in favor of safer bets.
Article

Addendum to NOT-NS-08-013, “NIH Administrative Revisions for Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources” (NOT-NS-08-020)
Link

New Frequently Asked Questions Added to OLAW Web Page (NOT-OD-08-058)
Link

Amendment to PAR-07-214: Academic-Industrial Partnerships for Development and Validation of In Vivo Imaging Systems and Methods for Cancer Investigations (R01) (NOT-CA-08-014)
Link

Amendment to PAR-07-214: Academic-Industrial Partnerships for Development and Validation of In Vivo Imaging Systems and Methods for Cancer Investigations (R01) (NOT-CA-08-014)
Link

CBER

SOPP 8206: Discontinuing Investigational and Related Applications (IRAs)
Link

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

Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
Link

GAO Should Probe FDA Oversight Of Researchers
Joe Barton of Texas and John Shimkus of Illinois wrote a letter to the GAO saying the FDA’s oversight of clinical trials needs to be reviewed “thoroughly.”
Article

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Proposed Changes to Regulatory Fees for Medicines and Medical Devices
Link

ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

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



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