Volume 8.35 | Sep 10

Volume 8.35, September 10, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Trial to Test Gene Therapy for Angina in Women: A trial testing a genetically engineered treatment in women who have angina, the piercing chest pain that can bedevil the millions of Americans with heart disease, has been given fast-track status by the U.S. Food and Drug Administration.

Human Source Of Stem Cells With Potential To Repair Muscle Identified: For the first time, scientists at Children’s Hospital of Pittsburgh of UPMC have discovered a unique population of adult stem cells derived from human muscle that could be used to treat muscle injuries and diseases such as heart attack and muscular dystrophy.


Point of Care Testing Conferece
October 22, 2007, New York City
Enter “CONNEXON” at checkout and receive 10% off registration.
Click here to register today.

Growing Living-tissue Heart Valves a Reality in 3-5 Years
Surgeons will soon be able to literally mend a broken heart using live tissue grown from a patient’s very own stem cells, top cardiologists have said.

International Stem Cell Corporation Creates Human Cornea Tissue From its Parthenote Stem Cells
International Stem Cell has announced that data from an independent third party laboratory has confirmed that it has successfully created tissue compatible with a human cornea from embryonic stem cells.

Neural Stem Cell Study Reveals Mechanism That May Play Role In Cancer
scientists have discovered a key mechanism of neuronal migration  – one that may also play an important role in other developmental processes and diseases, including cancer.

Making Gene Therapy Safer: Delivering Genes Via Polymers
In work that could lead to safe and effective techniques for gene therapy, MIT researchers have found a way to fine-tune the ability of biodegradable polymers to deliver genes.

Gene Therapy Promising Against Arthritis
Some of the most successful treatments for rheumatoid arthritis work by blocking an inflammatory factor called tumor necrosis factor or TNF, and now Dutch researchers have shown in animal experiments that the treatment can be delivered by gene transfer.

Bacteria Successful In Cancer Treatment
Bacteria that thrive in oxygen starved environments have been used successfully to target cancer tumours, delivering gene therapy based anti-cancer treatments, according to scientists.

Skin Stem Cells Used to Mend Spines of Rats
A Toronto-led team of researchers has found a way to use stem cells derived from skin to treat spinal cord injuries in rats.

ReNeuron Gives AGM Update on its ReN001 Stem Cell Therapy for Stroke
A pre-clinical study has now reached its end-point, and, subject to completion of data analysis, no significant or unusual adverse safety effects have been observed in either control or treatment groups.

Introgen’s p53 Immunotherapy Drug Candidate to Advance Into Second Phase 2 Clinical Trial in Small Cell Lung Cancer With National Cancer Institute
Introgen Therapeutics, Inc. and Moffitt Cancer Center have announced plans to begin a phase 2 randomized, controlled study of INGN 225, Introgen’s investigational immunotherapy product in patients with metastatic small-cell lung cancer.

Company Makes Bid for Elite Athletes’ Stem Cells
A Melbourne company is consulting elite sports clubs, including teams in the AFL, about athletes storing stem cells and using them to assist recovery from injuries.

Biobank to Boost Cancer Research
Australian cancer researchers will have access to one of the world’s most comprehensive collections of tissue samples with the launch Tuesday of a new biobank, the Victorian government says.

First Case Of Successful Ovarian Tissue Transplantation Between Two, Non-identical Sisters
A woman, whose ovaries had failed due to damage caused by chemotherapy and radiotherapy, has received a successful ovarian transplant from her genetically non-identical sister.


The Future (R)evolution of Preimplantation Genetic Diagnosis/Human Leukocyte Antigen Testing: Ethical Reflections
There has been increasing support for combining preimplantation genetic diagnosis (PGD) for specific diseases with a test for human leukocyte antigens (HLA) because the generation of HLA-matched umbilical cord blood cells may save the life of a diseased sibling. A proactive ethical analysis is needed and is presented in this article.

Markers and Methods for Cell Sorting of Human Embryonic Stem Cell-Derived Neural Cell Populations
To generate better-defined cell populations, we established a working protocol for sorting heterogeneous hESC-derived neural cell populations by fluorescence-activated cell sorting (FACS).


Britain to Allow Creation of Hybrid Embryos
Capping a months-long scientific and ethics review, British regulators said that they are prepared to allow the creation of embryos that are part human and part animal for use in medical experiments.

Cures Without Cloning Files Revision To Its Proposal Aiming To Modify Missouri Amendment Protecting Embryonic Stem Cell Research
The group Cures Without Cloning said it has filed with the Missouri Secretary of State changes in the language of its proposal seeking to modify a Missouri constitutional amendment that protects human embryonic stem cell research


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Teva to Invest in Stem Cell Start-up Cell Cure
The company is developing cell therapy cures for neural degenerative diseases, such as Parkinson’s disease, ALS, and multiple sclerosis, based on a platform of neural cells derived from human embryonic stem cells.

ViaCell Announces ViaCyte Collaboration with EMD Serono, Inc.
ViaCell, Inc. announced it has entered into an agreement under which EMD Serono, Inc. will provide support related to the clinical development of ViaCyteSM, ViaCell’s investigational product for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology.

International Stem Cell Corporation Opens European Distribution Channel, Signs Contract with CellSystems Biotechnologie Vertrieb
International Stem Cell announced it has entered into an exclusive distribution agreement with Germany-based CellSystems Biotechnologie Vertrieb GmbH, "CellSystems," to distribute its “Lifeline” brand of living human cell and cell culture research products throughout Europe.

National Stem Cell Bank Announces Addition of New Cell Lines
The National Stem Cell Bank has announced that it has received select human embryonic stem cell lines from Novocell, a leading stem cell engineering company based in San Diego.

Patent Application Licensed to CytRx Subsidiary RXi Pharmaceuticals Issues in Australia With Broad Claims to Expressed RNAi
CytRx Corporation’s majority-owned subsidiary, RXi Pharmaceuticals Corporation has announced the grant of an Australian patent issued to the University of Massachusetts Medical School covering in vivo production of small interfering RNA that mediate gene silencing.

University of Washington Gets Grant for Stem Cell Research
The University of Washington has been awarded $10 million by the federal government for a five-year program intended to advance basic research on human embryonic stem cells.

Baylor, M.D. Anderson to Share in $8.7M Grant
An $8.7 million five-year grant from the National Institute of General Medical Sciences has been awarded to scientists from Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center in Houston and UT Southwestern Medical School in Dallas to conduct human embryonic stem cell research.

BioLife Solutions Expands Scientific Advisory Board
BioLife Solutions, Inc. has announced the expansion of its Scientific Advisory Board (SAB) with the addition of two leading experts in cell therapy quality and regulatory assurance and in cryopreservation of stem cells derived from cord blood, dental pulp, and other sources.

CytRx Subsidiary RXi Pharmaceuticals Names Life Science Veteran Stephen J. DiPalma Chief Financial Officer
CytRx Corporation’s majority-owned subsidiary RXi Pharmaceuticals Corporation today announced the appointment of Stephen J. DiPalma as Chief Financial Officer. The Company also announced the planned departure of James Warren to pursue other opportunities.

Manoa BioSciences Inc. Leading Scientific Advisory Board in Transgenesis
Manoa BioSciences, Inc. is pleased to announce the formation of it’s renown Scientific Advisory Board and the launch of its commercial website offering products and services for discovery research.

BioE CEO Michael Haider Honored as a 2007 Twin Cities Business BioSciences Success Story
BioE(R), Inc. has announced that company President and Chief Executive Officer Michael Haider is one of Twin Cities Business magazine’s 2007 BioSciences Success Stories.


NIH Launches Interdisciplinary Research Consortia
The National Institutes of Health Roadmap for Medical Research will fund nine interdisciplinary research consortia as a means of integrating aspects of different disciplines to address health challenges that have been resistant to traditional research approaches.

Strength in Numbers: NIH Debuts Campaign to Empower Individuals to Pursue Careers in Research
The NIH’s Loan Repayment Program Strength in Numbers campaign debuted today. Offering a renewed commitment to qualified postdoctoral scientists who are seeking careers in biomedical and behavioral research, the program funds up to $35,000 annually in loan repayment.

Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21) (PAR-07-446)

Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R03) (PAR-07-447)


Workshop on Licensure of Apheresis Blood Products – Transcript

Approved Biological NDA and ANDA Applications – Update

Licensed Products and Establishments List – Update

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




Memorandum of Understanding Between the Food and Drug Administration and the University System of Maryland


2007/08 Annual Service Fee Invoices and Accompanying Fee Schedules


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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