Volume 7.22 | Jun 12

Volume 7.22, June 12, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Australian Research Breakthrough in Growing Human Organs: Australian researchers have grown beating heart tissue in the laboratory in a world-first breakthrough that could lead to the creation of entire human organs.


Beating-Heart Transplant UK First
The new technique involves keeping a donated heart warm and beating throughout the procedure, rather than packing it in ice for transport.

European Medicines Evaluation Agency Grants Mologen AG Medicine Status for Their Cell-Based Gene Therapy
Mologen AG announces that they obtained medicine status for their cell-based gene therapy against kidney cancer. This status was granted by Innovation Task Force (ITF), a committee of the European medicines evaluation agency, EMEA.

Approval Granted for Harvard Stem Cell Institute Researchers to Attempt Creation of Disease-Specific Embryonic Stem Cell Lines
After more than two years of intensive ethical and scientific review, Harvard Stem Cell Institute (HSCI) researchers at Harvard and Children’s Hospital Boston have been cleared to begin experiments using Somatic Cell Nuclear Transfer (SCNT) to create disease-specific stem cell lines in an effort to develop treatments for a wide range of now-incurable conditions afflicting tens of millions of people.

Cardium Reports Meta-Analysis of Angiogenic Gene Therapy Studies Shows Positive Effects in Men and Women With Heart Disease
Several positive findings have emerged from a review of the AGENT clinical data, which relates to the Company’s lead product candidate, Generx(TM) (Ad5FGF-4).

Oxxon Therapeutics HI-8™ MEL Therapeutic Vaccine Demonstrates Potential For Treatment of Metastatic Melanoma
The Phase II dose-escalation study has met its clinical endpoints, demonstrating that immunisation with Oxxon’s Hi-8(TM) MEL therapeutic vaccine is well tolerated at all doses and shows clinical benefit in HLA-A2 positive patients.

Oxford BioMedica PLC Reports New Encouraging Phase II Results With Trovax® And Progress In The Development Plan
Oxford BioMedica, a leading gene therapy company, has reported that encouraging data from five Phase II studies of TroVax, its lead cancer immunotherapy product, were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

Biovest International Presents Long Term Follow up Data on BiovaxID(TM) Treatment of Follicular Non-Hodgkin’s Lymphoma at American Society for Clinical Oncology Meeting
Biovest International Inc. delivered a presentation entitled “Idiotype Vaccine Therapy of Follicular Lymphoma in First Remission: Association of t(14;18) and Disease Free Survival in a Phase II Cohort” at the annual meeting of the American Society for Clinical Oncology in Atlanta, GA.

Biovest International, Inc. To Expand BiovaxID Phase III Trial In Ukraine And Russia; Regulatory Documents Filed
Biovest International, Inc. has filed for regulatory approval to open up to 30 new clinical sites for its pivotal Phase III trial of BiovaxID(TM) for the treatment of follicular non-Hodgkin’s lymphoma (NHL) — a major milestone for the Company.

Antigenics Presents Phase III Data from Trial of Oncophage in Metastatic Melanoma at ASCO Meeting
The overall median survival was 29 percent longer in patients who received at least 10 injections of oncophage. A combined population of stage IV M1a and M1b melanoma patients who received at least 10 vaccinations experienced increased survival of 143 percent.

Reovirus Could Be Used to Treat Many Forms of Advanced Cancer
In a world first, 30 patients received various intravenous dosages of Reolysin in a Phase I trial in the United Kingdom. The results demonstrated that Reolysin may have stopped the growth of tumors in some patients, or even shrunk tumors, without the side effects normally associated with more traditional forms of cancer therapy.

Cell Genesys and Medarex Announce Encouraging Interim Results from a Phase 1 Combination Therapy Trial With GVAX(R) Immunotherapy for Prostate Cancer and Ipilimumab (MDX-010) Antibody
Cell Genesys, Inc. and Medarex, Inc. have announced encouraging data from a Phase 1 clinical trial of Cell Genesys’ GVAX® immunotherapy for prostate cancer, administered in combination with Medarex’s fully human anti-CTLA-4 antibody, ipilimumab (MDX- 010), in patients with advanced prostate cancer.

Key To Future Stem Cell Production May Lie Inside The Testicles
British scientists have been granted permission to investigate whether stem cells found deep inside testicles can be used to repair damaged tissues and organs.

Gene Silencing Directs Muscle-derived Stem Cells To Become Bone-forming Cells
Using a relatively new technology called RNA interference to turn off genes that regulate cell differentiation, University of Pittsburgh researchers have demonstrated they can increase the propensity of muscle-derived stem cells (MDSCs) to become bone-forming cells.

Cell Therapy Technologies Announces Successful Use of Cord Blood Stem Cells to Prevent Oxygen Induced Lung Damage in a Neonatal Rat Model
This is the first demonstration in the world of the ability of cultured cord blood stem cells to prevent oxygen toxicity in the lung in a neonatal rat model.

Islet Cell Transplantation Significantly Improves Glycemic Control in Diabetes
Patients with type 1 diabetes who receive transplants of insulin-producing islet cells have significantly more stable blood glucose levels and fewer hypoglycemic episodes.

Gene Therapy Completely Suppresses Ovarian Cancer Growth in Animal Model
University of Pittsburgh School of Medicine researchers have used gene therapy to either completely abolish or significantly inhibit tumor progression in a mouse model of ovarian cancer.

Mouse Study Shows Gene Therapy Provides Temporary Protection from Radiation
University of Pittsburgh School of Medicine researchers have successfully protected mice against the damaging effects that radiation can have on bone marrow using gene therapy.

Gene Therapy Prevents The Onset Of Diabetic Symptoms In Mice
Using state-of-the-art gene therapy techniques, University of Pittsburgh investigators have successfully prevented the onset of elevated blood sugar, or hyperglycemia, in diabetes-prone mice by inserting a gene encoding for a cytokine—a protein that stimulates or inhibits the proliferation or function of immune cells—into their insulin-producing cells.

Muscle Bound: Gene Therapy Significantly Accelerates Healing of Damages Skeletal Muscle in Experimental Model
University of Pittsburgh School of Medicine researchers have successfully used gene therapy to accelerate muscle regeneration in experimental animals with muscle damage, suggesting this technique may be a novel and effective approach for improving skeletal muscle healing, particularly for serious sports-related injuries.

Bone Marrow May Restore Cells Lost in Vision Diseases
University of Florida scientists conducting experiments with mice have found evidence that the body naturally replenishes small amounts of cells in the eye essential for healthy vision.

Origen Therapeutics Publishes in Nature a Robust and Versatile Method for Creating Transgenic Chickens
Origen Therapeutics announced today that it has succeeded in developing a robust and versatile technology for genetically modifying chickens that, for the first time, puts avian transgenics on a par with transgenic mice.


Germline Transmission of Genetically Modified Primordial Germ Cells
The researchers show that chicken Primordial germ cells (PGCs) can be isolated, cultured and genetically modified while maintaining their commitment to the germ line. Furthermore, they show that chicken PGCs can be induced in vitro to differentiate into embryonic germ cells that contribute to somatic tissues.


European Parliament Committee Suggests Compromise on European 7th Framework Programme Funding for Stem Cell Research
The Industry, Research and Energy Committee (ITRE) of the European Parliament has suggested a compromise position on funding for stem cell research under the draft European 7th Framework Programme (FP7).

Definition Of Embryo Death Criteria May Open Doors For Stem Cell Research
A research team from Columbia has, for the first time, identified criteria through which embryo death can be confirmed. The implications for stem cell research are huge – by confirmation of embryo death, embryos could be harvested, just as organs are for transplantation, in order to generate stem cells for research and, ultimately, therapeutic purposes.

Governor Blagojevich Signs Law to Raise Awareness About Benefits of Umbilical Cord Blood Donations
Governor Rod R. Blagojevich has signed legislation to educate people about the benefits, costs, and uses associated with umbilical cord blood collection.


GE Healthcare and New York Blood Center Announce Milestone in Cord Blood Banking
New York Blood Center’s National Cord Blood Program is the first to automate the processing, cryopreservation and storage of cord blood stem cell units to achieve the highest standards of quality and consistency.

Gleneagles Alliance to Tap Into Stem Cell Treatment Demand
Gleneagles Hospital (KL) Sdn Bhd is positioning itself as a domestic and regional stem cell therapy, treatment and resource centre for heart and diabetic foot ulcers via a strategic alliance with StemLife Bhd and HSC Tele-Medic Sdn Bhd.

Pioneering New Labs to be Opened in North East England
A suite of laboratories that will help establish North East England at the forefront of medical research will be officially opened this week.

New Cord Blood Bank to Conduct Stem Cell Research
Researchers at a newly-opened cord blood bank are conducting stem cell research, using some of the stored blood, to reduce the incidence of genetic disease in the United Arab Emirates.

Daniel A. Szobel Appointed Vice-President of Global Operations for Stem Cell Company – TheraVitae Group
Dr. Valentin Fulga, CEO of TheraVitae, Group, has announced the appointment of Daniel A. Szobel, as Vice-President of Global Operations.

Phase III Medical Inc. Is Pleased To Appoint Robin L. Smith, MD, MBA As Chairman Of The Board And Chief Executive Officer
Phase III Medical, Inc. has announced the appointment of Robin L. Smith, MD, MBA as Chairman of the Board and Chief Executive Officer.


NIH Expands Initiative to Encourage Bench-To-Bedside Research
The National Institutes of Health has awarded nearly $4 million to fund 19 bench-to-bedside medical research projects designed to speed translation of promising laboratory discoveries into new medical treatments.

Reminder for Applicants Considering the Multiple PI Option (NOT-OD-06-074)

Notice of NHLBI Participation in PA-06-368 (R21) and PA-06-369 (R01) Research on Ethical Issues in Human Subjects Research

Notice of the Intention of NHLBI to Release a Career Development Program in Chronic Lung Diseases Genetics and Genomics (NOT-HL-06-120)


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

Current Licensed Establishments and Products


Food and Drug Administration (United States of America)

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

Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Consultation Begins on Proposed Australia New Zealand Therapeutic Products Regulatory Scheme

Consultation Documents Released


AABB-ISCT Cellular Therapy Audioconference Series

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

Profiled Journal

Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA

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