Volume 6.45 | Nov 7

Volume 6.45, November 7, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Applications Flood Stem Cell Bank: A new global stem cell centre in South Korea says it has been inundated with applications from patients willing to take part in research at the institute.
Article

Dendreon Announces FDA Grants Fast Track Status for Provenge: Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track review status to PROVENGE® (sipuleucel-T) for its proposed use in the treatment of asymptomatic men with metastatic, androgen-independent prostate cancer.
Article

Science

Researchers Use ‘Trickery’ to Create Immune Response Against Melanoma
A new type of immunotherapy in which dendritic cells are tricked into action against cancer when they are exposed to harmless pieces of viruses and bacteria is described in the November issue of Cancer Research.
Article

Gene Therapy Improves Gemcitabine Effects in Experimental Glioma Model
Attempts to improve the chemotherapeutic efficacy and radiotherapy-sensitivity of the anticancer agent, gemcitabine, using gene therapy have yielded interesting results in preclinical glioma models presented at the 13th European Cancer Conference (ECCO).
Article

Los Angeles Hospital Disbands Liver Transplant Program in Wake of Scandal
A Los Angeles hospital is ending its liver transplant program after officials acknowledged in September that doctors gave an organ to a man who was not among the neediest patients.
Article

Clinical Trials with Immunotherapy for Breast and Colorectal Cancer
Researchers at Mount Sinai School of Medicine are conducting clinical trials on a unique approach to enhance the immune system in patients with breast or colorectal cancer.
Article

Adult Stem Cells May Be Just Remnants Of Evolution
Researchers from the Max Planck Institute for Heart and Lung Research in Bad Nauheim, Germany have now demonstrated, in a study published in the journal Molecular and Cellular Biology, that at least some adult stem cells could be the mere remnants of former embryonal differentiation processes, or, in other words, “footprints” of evolution.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Feasibility of Cord Blood Stem Cell Manipulation with High-energy Shock Waves: An In Vitro and In Vivo Study
The pretreatment of CD34(+) cells with HESW represents a new method to manipulate the CD34(+) population without interfering with their ability to both expand and engraft and it might be considered as a tool for genetic approaches.
Abstract

Pharmacological and rAAV Gene Therapy Rescue of Visual Functions in a Blind Mouse Model of Leber Congenital Amaurosis
A combination of intraocular gene therapy and pharmacologic bypass provides a complementary way to restore retinal function in an animal model of human hereditary blindness.
Abstract

Repair of Impaired Myocardium by Means of Implantation of Engineered Autologous Myoblast Sheets
Myoblast sheets repaired the impaired myocardium, reduced fibrosis, and prevented remodeling in association with recruitment of hematopoietic stem cells through the release of stromal-derived factor 1 and other growth factors.
Abstract

Policy

Korean Stem Cells Not for Everyone
Scientists in countries with the most restrictive policies on research cloning may not be able to take advantage of the international consortium based in South Korea, which was hailed this month as a means to provide stem cells to researchers living in restrictive environments.
Article

Japan Vows to Speed Device Approvals
Japan has vowed to accelerate regulatory reforms that will speed the introduction of safe, effective and innovative medical devices to Japanese consumers, according to a new joint U.S.-Japan government trade report on regulatory reform and competition policy.
Article

California Institute for Regenerative Medicine Opens Doors in San FranciscoMission Bay
The permanent headquarters of the California Institute for Regenerative Medicine (CIRM) opened its doors for the first time today in San Francisco. City Mayor Gavin Newsom and ICOC Chairman Bob Klein cut the ribbon to 210 King Street this morning and toured the remodeled 20,000 square-foot facility.
Article

Business

Osiris Therapeutics, Inc. Reaches Safety Milestone In Stem Cell Clinical Trial For Cardiac Patients
Osiris Therapeutics, Inc. announced today that its multi-center, human clinical stem cell trial for the treatment of patients suffering from heart attacks has successfully passed the first safety milestone of the trial.
Article

Dendreon’s Second Randomized Phase 3 D9902A Trial of Provenge Extends Survival in Patients with Advanced Prostate Cancer
Dendreon Corporation (Nasdaq: DNDN) today announced that final results of its second Phase 3 study (D9902A) of PROVENGE(R) (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference.
Article

Progenitor Cell Therapy Commences Expansion of Its Cell Therapy Manufacturing Facility in Mountain View, California
Progenitor Cell Therapy, LLC (PCT), a leading full service cell therapy development and contract manufacturing company, announced today that it has started construction on the next expansion phase of its cGMP/cGTP cell therapy manufacturing facility in Mountain View, California.
Article

CalbaTech, Inc.’s Subsidiary, LifeStem Inc. Files Provisional Patent Application For Stem Cell Microbank And To Trademark “Stem Cell Microbank”
CalbaTech, Inc., an emerging life sciences company concentrating on providing products and platforms to the research market for biotech and pharmaceutical companies and to academic institutions, announced today that its wholly owned subsidiary, LifeStem, Inc., filed for US Trademark protection for the name of its stem cell collection service, Stem Cell Microbank, and filed a provisional patent application on the process of the Stem Cell Microbank for its process of stem cell banking.
Article

Endocyte Near Patent for Cancer Treatment Technology
The Purdue Research Park firm announced Wednesday that the U.S. Patent and Trademark Office has issued it a notice of allowance for a patent encompassing a proprietary treatment method that helps the immune system find and destroy cancer cells.
Article

Tissera Reports Encouraging Interim Results of Its Ongoing Large Animal Experiments of Pancreatic Xenotransplantation
Tissera, Inc. (OTCBB:TSSR) reports encouraging interim results of its ongoing large animal model experiments of pancreatic xenotransplantation, designed for the future treatment of insulin-dependent (type I) diabetes mellitus.
Article

BrainStorm Announces Significant Preclinical Benefit of Its GDNF Producing Stem Cells in Animal Models of Parkinson’s
BrainStorm Cell Therapeutics (OTCBB:BCLI), today announced that the company’s scientific collaborators at Tel Aviv University had successfully implanted human bone marrow derived stem cells into animal models of Parkinson’s disease and observed improved motor function within just two weeks of implantation.
Article

Cytori Therapeutics, Inc. Enters Strategic Regenerative Medicine Collaboration With Olympus Corporation
As part of the terms and agreements, the two companies will form a 50:50 Joint Venture, Olympus-Cytori, Inc., to develop and manufacture future generation devices based on Cytori’s Celution™ System.
Article

Targeted Genetics Presents Additional Data from Its Inflammatory Arthritis Program at the 13th Annual Congress of the European Society of Gene Therapy
Results demonstrate safety and reduction of mean tenderness and swelling scores of the treated joint; results support continued study of tgAAC94 in conjunction with TNF-alpha antagonists in inflammatory arthritis
Article

Peregrine Pharmaceuticals Announces Defense Department Grant to Study Tarvacin(TM) Platform for Prostate Cancer
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM – News), a biopharmaceutical company with a portfolio of innovative, clinical-stage product candidates for viral diseases and cancer, today announced the U.S. Department of Defense Prostate Cancer Research Program has awarded a grant totaling $582,988 to the University of Texas Southwestern Medical Center at Dallas to study the use of vascular targeting antibodies in combination with chemotherapy agents for the treatment of prostate cancer.
Article

Cambridge Antibody Technology Group PLC (CATG) Acquires Oncology Product Candidates From Genencor International, Inc.
Cambridge Antibody Technology today announces the acquisition of product candidates GCR-3888 and GCR-8015 from Genencor, a subsidiary of Danisco, based in Palo Alto, California.
Article

Stem Cell Sciences, Inc. Grants Lexicon Genetics Incorporated (LEXG) Exclusive License To IRES Technology
Lexicon Genetics Incorporated and Stem Cell Sciences plc (AIM: STEM) announced today a significant expansion related to Lexicon’s rights to SCS’s proprietary Internal Ribosome Entry Site (“IRES”) technology for genetically modified mice. IRES technology is commonly used to enhance the accuracy of gene expression in genetically altered mice and cultured stem cells.
Article

Oxford BioMedica Seeks £30m for Cancer Drug Trials
Oxford BioMedica, the speculative biotechnology company formed out of the Oxford University a decade ago, is talking to fund managers about a fund-raising to pay for large-scale trials of a cancer treatment.
Article

AnorMED To Commence Trading On AMEX
AnorMED Inc. (the “Company” or “AnorMED”) is pleased to announce that the United States Securities & Exchange Commission has declared the Company’s registration statement on Form 40-F effective on November 3, 2005.
Article

Albany Molecular Research, Inc. Opens New Facilities in Singapore and India
Albany Molecular Research, Inc. (Nasdaq: AMRI) today announced that its wholly owned subsidiary, Albany Molecular Research Singapore Research Centre, Pte. Ltd. (AMRSRC), has moved into permanent laboratory facilities in Singapore that provide room for significant growth.
Article

Jonathan Lakey, Ph.D. Presents the Edmonton Protocol for Islet Cell Transplantation to the Sanguine Medical Advisory Board
The medical advisory board of Sanguine Corp. (OTCBB: SGNC), a bio-pharmaceutical company focused on the development of oxygen-carrying synthetic substitutes for human red blood cells and numerous other areas requiring oxygen perfusion, received a presentation from Dr. Jonathan Lakey, the director of the Clinical Islet Laboratory at the University of Alberta at Edmonton related to the Edmonton Protocol, including the use of PHER-O2.
Article

Immucor (BLUD) To Close Its Houston Manufacturing Facility
Immucor, Inc. , the global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced today it plans to close its Houston, Texas manufacturing facility.
Article

AssurX Announces Immediate Availability of CATSWeb Process for Document Control
AssurX, Inc., the leader in Enterprise Quality and Compliance Systems, today announced the immediate availability of CATSWeb Process for Document Control, allowing built-in, easy and effective management of the controlled content life cycle from change orders through release approval, dissemination and training.
Article

Cellerant Therapeutics, Inc. Appoints Ramkumar Mandalam As Vice President Of Pharmaceutical Operations
Cellerant Therapeutics, Inc. today announced that Ramkumar Mandalam, Ph.D., has joined Cellerant Therapeutics as Vice President of Pharmaceutical Operations.
Article

NIH

Dr. Kishor Bhatia to Head National Cancer Institute AIDS Malignancy Program
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), has announced the appointment of Kishor Bhatia, Ph.D., as director of the new AIDS Malignancy Program (AMP). Bhatia has served as the program director for the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, since 2004 and his appointment to AMP was effective Oct. 2, 2005.
Link

NIH Offers $35,000 in Annual Student Loan Repayment
On Thursday, September 1, 2005, the National Institutes of Health (NIH) began accepting applications to its five Loan Repayment Programs (LRPs). Deadline for applications is December 1, 2005.
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NIH Guide for Grants and Contracts – Week Of November 4, 2005
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Assay Development for High Throughput Molecular Screening (R03/R21) (RFA-RM-06-004)
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Novel Technologies for In Vivo Imaging (STTR [R41/R42]) (PA-06-045)
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NCI Phase II Small Business Innovation Research Renewal Awards for Cancer Diagnosis, Prevention, and Treatment (SBIR [R44]) (PA-06-051)
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NCI Phase II Small Business Technology Transfer Renewal Awards for Cancer Diagnosis, Prevention, and Treatment (STTR [R42]) (PA-06-052)
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CBER

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

Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) (COBAS AmpliScreen HBV Test) Supplement Approval – Roche Molecular Systems, Inc
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Medical Device Notification: Transfer Set with 150 Micron Filter – Charter Medical Ltd
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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Cleared Biological 510(k) Device Applications – Update
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Approved Biological NDA and ANDA Applications – Update
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Regulatory

MedSafe (New Zealand)

An Invitation to attend Medical Device Regulatory Seminars to be held in November/December 2005
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ISCT

2005 Cell Therapy Audioconference Series
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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

This issue contains:

Persistence makes perfect: the benefits of IL-2 in adoptive immunotherapy

Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement

Fate and function of anti-CD3/CD28-activated T cells following adoptive transfer: IL-2 promotes development of anti-tumor memory T cells in vivo

IL-2-activated cord blood mononuclear cells

Expression and recombination of the EGFP and EYFP genes in lentiviral vectors carrying two heterologous promoters

Selective and efficient culturing of retinal pigment epithelial cells using a feeder layer

Innovative strategies for PBPC mobilization

Anterior cruciate ligament constructs fabricated from human mesenchymal stem cells in a collagen type I hydrogel

Stem cell therapy still not here

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.
http://journalsonline.tandf.co.uk/link.asp?id=107693



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