Volume 7.20 | May 29

Volume 7.20, May 29, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

University of Florida Scientists Restore Sight to Chickens with Blinding Disease: University of Florida scientists have delivered a gene through an eggshell to give sight to a type of chicken normally born blind.


Genetic Transfer May Help Treat Impotence
In the first human trial to investigate gene transfer as a treatment for impotence, also referred to as erectile dysfunction, the approach appeared to be safe and provided some evidence that it is effective.

Scientists Create Artificial Penis
In the study, adult male rabbits with severely damaged penises received a graft of specially engineered penile tissue. The animals then re-grew full penises that functioned normally — even to the point of successfully impregnating females.

A Simple Injection Of Stem Cells From A Woman’s Own Muscle May Effectively Treat Urinary Incontinence
In the first clinical study of its kind in North America, women with stress urinary incontinence (SUI) were treated using muscle-derived stem cell injections to strengthen deficient sphincter muscles responsible for the condition.

Research in Stem Cells Produces Promising Results for Lupus Sufferers
In what is being called a huge development, researchers have found stem cells can wipe out lupus in certain patients.

University of Florida Scientists Restore Sight to Chickens with Blinding Disease
University of Florida scientists have delivered a gene through an eggshell to give sight to a type of chicken normally born blind.

Repairing the Heart with Cell Therapy and Nanofibers
The new system allows greater control of the intramyocardial environment by delivering growth factors to an injured heart muscle and using peptide nanofibers for prolonged delivery of the injected factor.

Published Independent Study Confirms Superiority of BioLife’s Products in Preserving Cord Blood Derived Stem Cells
BioLife Solutions, Inc., a leading manufacturer and marketer of cryopreservation solutions for the preservation of cells and tissues at low temperatures, announced today that an independent study published in the peer review journal Cytotherapy found BioLife’s CryoStor(TM) family of products to be significantly superior compared to traditional cord blood preservation methodologies.

HepaLife Technologies Inc.’s Liver Cell Function Plays Vital Role In Toxic, Brain Damaging Disease; National Institutes of Health (NIH) Launchs $71 Million Research Initiative
“HepaLife’s PICM-19 cell line is the only known, embryonic liver stem cell line of its kind with the ability to produce substantial amounts of urea, in an in vitro system,” explained Mr. Harmel S. Rayat, President and CEO of HepaLife.

Cancer Vaccine Shows Promise in Mice
The vaccine works by mimicking the effects of angiostatin, a piece of a protein that suppresses tumor growth by preventing new blood vessels from forming in tumors. This is a treatment strategy known as antiangiogenesis.

Cell Genesys Reports Interim Results of CG0070 Phase 1 Trial in Bladder Cancer
Cell Genesys, Inc. today announced preliminary results of a Phase 1 clinical trial of CG0070 in patients with recurrent bladder cancer who have failed previous therapy with bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer.

Northwest Biotherapeutics Updates Brain Cancer Clinical Data
Northwest Biotherapeutics has released encouraging updated phase I survival and progression data on patients who have received DCVax-Brain, a therapeutic personalized cancer vaccine.

Long-Term Results from TNFerade(TM) Pancreatic Cancer Study and Updated Survival Results from TNFerade(TM) Esophageal Cancer Study Both Reported at Digestive Disease Week
GenVec, Inc. announced today that Kenneth Chang, M.D., medical director of the Comprehensive Digestive Disease Center at the University of California at Irvine and a clinical investigator for several studies involving GenVec’s investigational cancer drug TNFerade(TM), presented updated survival information from a clinical study demonstrating the potential utility of TNFerade in treating patients with esophageal cancer.

Positive Results for Prima BioMed’s Ongoing Phase IIa Ovarian Cancer Trial
A second analysis of data made available to Prima’s Scientific Advisory Panel (SAP) indicated that so far 21 per cent of patients in the trial had achieved either a clinical response to treatment or stabilisation of their disease.

Oxford BioMedica PLC Commences Phase II Trial Of Trovax(R) In Prostate Cancer
Oxford BioMedic, a leading gene therapy company, announced that a Phase II trial of TroVax in patients with prostate cancer that is unresponsive to hormone therapy is open for recruitment.

GVAX(R) Improves Survival in Metastatic Hormone-Refractory Prostate Cancer
Researchers have reported that the investigative immunotherapy agent GVAX improves predicted survival time with little toxicity in patients with metastatic hormone-refractory prostate cancer (HRPC).

Cell Analysis System Gleaned from Earth Sciences Technique
By combining multispectral analysis with flow cytometry, researchers can study a single cell in 32 colors. Such a complete spectral signature could help them better diagnose disease.


Isolation of a Novel Population of Multipotent Adult Stem Cells from Human Hair Follicles
The researchers isolated a novel population of multipotent adult stem cells from human hair follicles, and these cells appear to be located in the bulge area.

Current Prospects for Adult Stem Cell–Based Therapies in Ocular Repair and Regeneration
Here the researchers discuss the current prospects for the application of various adult ocular stem cells to human therapies for restoration of vision.


Proponents Press Senate on Stem Cell Research Measure
A full year after the House passed legislation that would loosen President Bush’s restrictions on human embryonic stem cell research, the Senate is coming under intense pressure to tackle the controversial bill.

Catholic Church Set to Promote Adult Stem Cell Research
New Jersey’s leading adversaries in the debate over embryonic stem cell research have come together to promote the donations of placenta and umbilical-cord blood.


Medistem Files U.S. Patent Application for Innovative Stem Cell Technology to Treat Lower Back Disorders
Medistem Laboratories, Inc., committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, announced its filing of a U.S. patent application for an innovative cellular technology to treat lower back ailments by addressing causal issues and developing methodologies to prevent disc degeneration.

Stem Cell Therapeutics Announces Issuance of Third US Patent
The patent, entitled “Combined Regulation of Neural Cell Production”, protects novel methods of treating patients suffering from a variety of central nervous system (CNS) disorders including stroke, brain injury, Alzheimer’s disease, multiple sclerosis, Huntington’s disease, and others.

Oncolytics Biotech Inc. Announces Issuance of 16th U.S. Patent
Researchers at Calgary-based Oncolytics Biotech Inc., have patented a way to use the reovirus to purge cancer cells from autologous stem cell transplants that are reintroduced to the body following high-dose chemotherapy.

Endocyte Receives Patent to Better Target Cancer Cells
Endocyte Inc. announced that a patent has been issued for a proprietary technology designed to target the body’s immune system to cancer cells.

United Kingdom Stem Cell Lab Likely to Open Office in the Bay Area
The Bay Area’s reputation for stem-cell research got another boost, with the announcement that Stem Cell Sciences of England is close to opening an office in this area.

Global Hospital Begins Adult Stem Cell Therapy
Initially, Global Hospitals intends to focus on spinal cord injuries and cardiac dysfunction, wherein alternative treatment is usually not available.

The Juvenile Diabetes Research FOundation (JDRF) Partners with the Canadian Institutes of Health Research
The Juvenile Diabetes Research Foundation (JDRF), the world’s largest charitable funder of research in type 1 diabetes and its complications, has announced a partnership with the Canadian Institutes of Health Research (CIHR) to support an initiative in Regenerative Medicine and Nanomedicine.

New Company, Biorigen USA Inc., is to Enter $4-$6 Billion Market Of “Bone Repair By Tissue Engineering”
New Life Scientific, Inc. has announced that it has established Biorigen USA, Inc., a joint venture company with Biorigen Srl, a Biotech Company, and Centro Biotecnologie Avanzate, to pursue development of a series of research projects, the first one being the project of “Bone Repair by Tissue Engineering”.

MultiCell Technologies Appoints Stephen Chang, Ph.D., as Chief Executive Officer
MultiCell Technologies, Inc., a developer of therapeutics for the treatment of degenerative neurological diseases, metabolic and endocrinological disorders, and infectious diseases, announced today that Stephen M. Chang, Ph.D. has been appointed as its new Chief Executive Officer in addition to his current role as President.

Clinical Cell Culture has Appointed Bob Atwill as its New CEO
Clinical Cell Culture Ltd. announced that it has appointed Bob Atwill as its new Chief Executive Officer and a Director of the Company.

AnorMED Says CEO To Step Down Immediately
The Board of Directors of AnorMED Inc. announced that Dr. Mike Abrams has stepped down as President and Chief Executive Officer, effective immediately.



Eighth Annual NIH SBIR/STTR Conference, July 13, 2006 (NOT-OD-06-072)

Amendment to PA-06-418: Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21] (NOT-HL-06-127)

New Push for NIH Funding Urged
Senators urged research advocacy groups and universities yesterday to step up efforts to win more federal funding for the National Institutes of Health, the federal agency that funds most of the country’s medical research but is facing a third consecutive year of cuts.


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

FDA Clinical Trial Requirements – Regulations, Compliance, and GCP – Slide Presentation
Link1 Link2

Biological Product Deviation Reports – Annual Summary for Fiscal Year 2005

Biologics Product Shortages – Updated CytoGam


Food and Drug Administration (United States of America)

International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; Availability

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Financial Disclosure by Clinical Investigators

Indian Council of Medical Research (India)

Guidelines On Stem Cell Research
The national guidelines for stem cell research and therapy are being formulated jointly by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT).

Medicines and Healthcare products Regulatory Agency (United Kingdom)

Relocation of MHRA Central Region Office

World Health Organization

The World Health Organization announces new standards for registration of all human medical research
As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun.


AABB-ISCT Cellular Therapy Audioconference Series

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

Profiled Journal

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Current Volume: Volume 8 Number 2 / May 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.