Volume 6.47 | Nov 21

Volume 6.47, November 21, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Blood Vessels Grown From Patient’s Skin: Scientists from Cytograft Tissue Engineering Inc., a San Francisco Bay-area biotechnology company, reported Tuesday that two kidney dialysis patients from Argentina have received the world’s first blood vessels grown in a lab from snippets of their own skin.

Polymer Gel Can Block Toxic Leakage Problem in Gene Therapy: Duke University biomedical engineers have devised a potentially patentable method to arrest toxic leakages of genetically engineered viruses that have plagued attempts to use gene therapy against cancerous tumors.


Stem Cells Used to Grow Cartilage
Imperial College London scientists report they have converted human embryonic stem cells into cartilage cells.

Statin May Stimulate Stem Cells
University of Buffalo scientists say a widely used statin designed to decrease high cholesterol might stimulate stems cells for heart repair.

Bone Marrow Cells No Help After Heart Attack
In a new study that apparently contradicts a recent trial, injecting patients with their own progenitor bone marrow cells a few days after a heart attack failed to improve the organ’s function or reduce damage.

Progenitor Cells Stem Damage After Heart Attack
When infused with progenitor bone marrow cells, these patients showed almost double the improvement in the heart’s ability to pump blood as did patients who were given a placebo.

Can Sperm Mimic Embryo Stem Cells?
Researchers at University of Texas Southwestern University said this week they are close to getting sperm cells to act like embryonic stem cells.

Stem Cell Therapy Helps MS Woman
A young Inverness woman with multiple sclerosis has said she is able to walk for the first time in years only days after revolutionary stem cell therapy.

University Of Pittsburgh Researchers Use Gene Therapy To Prevent Cardiac Rupture And Prolong Life In Mouse Model Of Heart Attack
A University of Pittsburgh research team has found that gene vector carrying an inhibitor of metalloproteinase-2 (MMP-2), a protein shown to stimulate adverse healing in heart tissue after a heart attack, protected experimental mice against further cardiac damage and subsequent death.

Studies Show Apo A-I Milano Gene Transfer and Antibody Therapy Cut Atherosclerotic Plaque
Cardiology researchers at Cedars-Sinai Medical Center have found that a single injection of a harmless virus engineered to carry a beneficial, mutant gene enabled animals to manufacture their own supply of the gene’s protein product that protects against plaque buildup in blood vessels.

Gene Therapy Hope for People with Blood Disorders
Researchers in the new Medical & Molecular Genetics labs at King’s College London have created a vector that could be used in the gene-therapy treatment of people with the blood disorders beta-thalassaemia and sickle cell disease.

Exercise Plus Gene Therapy Shows Promise For Treating Lou Gehrig’s Disease
A new study in mice gives hope that a combination of gene therapy and exercise may extend the lives of people who have Lou Gehrig’s disease.

Gene Therapy Potential for Treatment of Pancreatic Cancer
A gene responsible for the production of a protein called vasostatin may prove a promising new way of treating pancreatic cancer, suggests research published ahead of print in Gut.

New Gene Silencing Therapy for Cervical Cancer
Researchers at The University of Queensland’s (UQ) Centre for Immunology and Cancer Research (CICR), based at the Princess Alexandra Hospital, have pioneered a new approach for the treatment of cervical cancer.

Neurons Generated in the Adult Brain Learn to Respond to Novel Stimuli
The new olfactory neurons are especially sensitive to novel stimuli, preferentially learning to respond to new odors. This level of flexibility suggests that such newly-generated neurons could be induced to adapt to and integrate into other regions of the brain, perhaps allowing them to replace neurons lost to injury or disease.

Stem Cell Scientist Quits Korean Team Over Ethics
A leading US human embryo scientist has severed links with a top Korean researcher, saying he believes ethical rules on the procurement of human eggs were broken and that he was misled about the issue.


The Dying Stem Cell Hypothesis: Immune Modulation as a Novel Mechanism for Progenitor Cell Therapy in Cardiac Muscle
We propose that apoptosis of transplanted cells modulates local tissue reactions.

Proliferation of Cardiomyocytes Derived From Human Embryonic Stem Cells is Mediated via the IGF/PI 3-kinase/Akt Signaling Pathway
This system should permit identification of regulatory pathways for human cardiomyocyte proliferation and may facilitate expansion of cardiomyocytes from human ES cells for therapeutic purposes.

CCR2-64I and CXCL12 3’A Alleles Confer a Favorable Prognosis to AIDS Patients Undergoing HAART Therapy
Our results suggest that patients carrying either CCR2-64I or CXCL12 3’A have a more favorable prognosis during HAART treatment.


Progenitor Cell Therapy Announces Collaboration with BD to Co-Develop and Market Assays for the Growing Cell Therapy Industry
Progenitor Cell Therapy, LLC (PCT), a leading cell therapy manufacturing and services company, today announced an agreement with BD Biosciences, a segment of Becton, Dickinson and Company (BD), to co-develop and market products and services for the cell therapy industry, including: product characterization and comparability assays; in-process and final product release tests; and PCT’s contract cell therapy development and manufacturing platform resources.

GE Healthcare and Saneron Announce a Research Collaboration for the Development of Umbilical Cord Blood Processing
GE Healthcare, a unit of General Electric Company (NYSE: GE), and Saneron today announced an R&D agreement to optimize GE Healthcare’s Ficoll-Paque™ for the isolation of stem cells from umbilical cord blood.

Stem Cell Sciences Advances Towards Its First Cell Therapy Program for Degenerative Disease
Stem Cell Sciences plc (AIM: STEM), the global stem cell company, today announced that Stem Cell Sciences KK (SCS KK), an affiliated company of Stem Cell Sciences plc (SCS plc) in Japan, has signed a worldwide exclusive license agreement with The Universite de Nice Sophia-Antipolis, France (University of Nice), to commercialise human multipotent adipose-derived stem cells (hMADS) and technologies which will form the basis for a cell therapy programme focused on degenerative diseases including Duchenne Muscular Dystrophy (DMD).

FDA Clears Baxter’s Amicus for Seven-day Storage of Platelets
The FDA has granted 510(k) clearance for the seven-day storage of a type of blood platelets collected on Baxter Healthcare’s Amicus Separator and stored in Baxter’s PL 2410 collection container.

Osteotech Grafton(R) DBM Family of Products Receives FDA 510(k) Clearance Extension
Osteotech, Inc. (Nasdaq: OSTE) announced today that it has been informed by the Food and Drug Administration (“FDA”) that FDA is granting Osteotech an extension to clear its previously filed Grafton(R) DBM 510(k) applications until such time as the Agency is able to complete its work on the applications.

First Oncolytic Viral Therapy Approved for Head and Neck Cancer
Shanghai Sunway Biotech Co. Ltd. announced today that the Chinese State Food and Drug Administration (SFDA) has approved H101, an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory Nasopharyngeal cancer, a type of head and neck cancer prevalent in China.

Norwood Immunology – Phase II Clinical Trial – Melanoma Cancer Vaccine; First Patient Injected
Norwood Abbey Limited (OTC:NABYF) (ASX:NAL) today announced that its subsidiary, Norwood Immunology Limited (AIM:NIM), a company focussed on the rejuvenation of the immune system, commenced its Phase II clinical trial.

Vaccine Administered Following Pancreatic Cancer Surgery and Adjuvant Therapy
Cell Genesys, Inc. (Nasdaq: CEGE) today announced interim findings from a Phase 2 clinical trial of GVAX(R) vaccine for pancreatic cancer in 60 patients with operable pancreatic cancer who received the vaccine after surgical resection of their tumor and adjuvant radiation and chemotherapy.

ReNeuron announces First Results from Key Pre-clinical Safety Studies with its Lead ReN001 Stem Cell Line for Stroke
ReNeuron Group plc (LSE: RENE.L) today announced that it has generated provisional pre-clinical data indicating that its lead ReN001 cell line for stroke does not form tumours following implantation.

Neurologix Pre-Clinical Results Show Potential for Gene Therapy Treatment of Huntington’s Disease
Neurologix, Inc. (OTCBB: NRGX) today announced findings from preclinical studies, which showed that the gene XIAP (X-linked inhibitor of apoptosis) may prevent the progression of Huntington’s disease.

ReGen Biologics, Inc. Signs Exclusive Distribution Agreement For Spain
ReGen Biologics, Inc. (OTC:RGBI) an orthopedic products company that develops, manufactures, and markets innovative tissue growth and repair products, announced today an exclusive two-year distribution agreement with Hoscenter to market the ReGen(R) CMI(TM) in most areas of Spain.

Mozobil(TM) Abstracts Accepted for Presentation at the American Society of Hematology Conference
AnorMED Inc. (AMEX:AOM;TSX:AOM) announced today that 12 clinical and preclinical abstracts on MOZOBIL(AMD3100), a first in class stem cell mobilizer, have been accepted for presentation at the American Society of Hematology (ASH) annual meeting, being held in Atlanta, Georgia, December 10-13th, 2005.

ImmunoGen, Inc. Announces Presentation of HuN901-DM1 Clinical Data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
As reported today, clinical activity seen with huN901-DM1 in this study includes a complete remission lasting at least 15 weeks and stable disease lasting up to 18 weeks.

Inex to Spin Off Targeted Immunotherapy Assets into New Company
Shares of Inex Pharmaceuticals Corp. gained more than 20 per cent Thursday after the drug developer said it plans to spin off part of its business into a new company and focus on the development of its anti-cancer treatment Marqibo.

Ellen Areman Joins BCG
Ellen Areman, MS, SBB (ASCP) has joined the Biologics Consulting Group, LLC, as a Senior Consultant



NIH Guide for Grants and Contracts – Week Of November 18, 2005

NIH Director’s Pioneer Award Program (DP1) (RFA-RM-06-005)


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

Tissue Action Plan

CBER Perspectives on Manufacturing Facility Design and Equipment for Processes Utilizing Mammalian Cell Culture (Slides)

2005 Biological Approvals – Update

Human Cell & Tissue and Cellular & Tissue-based Products (HCT/P) Inspection Data – Update


Food & Drug Administration (United States of America)

Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion
The Food and Drug Administration (FDA) is announcing that the Center for Drug Evaluation and Research (CDER) will assign new numbers to a group of investigational new drug applications (INDs). In 2003, FDA transferred certain product oversight responsibilities from the Center for Biologics Evaluation and Research (CBER) to CDER. The consolidation of INDs transferred from CBER with CDER INDs resulted in INDs with duplicate numbers. To resolve this issue, CDER is renumbering some INDs that were submitted to CDER before the consolidation.


2005 Cell Therapy Audioconference Series

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

Cytotherapy/Telegraft Advertising Offer
Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

Here’s how the deal works:

Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

Current Volume: Volume 7 Number 5/November 2005

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.