Volume 7.04 | Feb 6

Volume 7.04, February 6, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Life-Threatening Lupus Responds To Stem Cell Transplant Therapy: Transplanting patients with blood stem cells that originate from their own bone marrow can induce the remission of life-threatening, treatment-resistant lupus, according to a study that took place at Northwestern Memorial Hospital in Chicago.
Article

FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps): Under its comprehensive framework for ensuring the safety of human tissue products, the U.S. Food and Drug Administration (FDA) today ordered Biomedical Tissue Services, Ltd. (BTS), of Fort Lee, NJ, a human tissue-recovery firm, and its CEO and Executive Director of Operations, Michael Mastromarino, D.D.S., to immediately cease all manufacturing operations.
Article

Science

Researchers Find Stem Cells for Repairing Lungs
South Korean researchers say they cultivated stem cells that appear to be useful in treating lung ailments.
Article

Prima’s Phase I trial of CancerVac(TM) Technology Published in Clinical Cancer Research Journal
Prima Biomed Ltd (ASX:PRR, ‘Prima’) is pleased to announce that a paper submitted on its Phase I clinical trial with the CancerVac™ MFP technology for advanced adenocarcinoma was accepted in the major peer-reviewed journal, Clinical Cancer Research and has now been published.
Article

UBC / Canadian Blood Services Researcher Invents Device to Boost World Supply, Quality of Blood Platelets
Cancer and open-heart surgery patients, disaster victims, organ or bone marrow transplant recipients, and others who require life-saving blood platelet transfusions will benefit from equipment invented by a researcher at the University of British Columbia’s Centre for Blood Research (CBR).
Article

Oregon Researchers Find Gene Therapy May Halt Progression Of Macular Degeneration
The multicenter phase I clinical trial revealed that injecting a gene directly into the eye to inhibit blood vessel growth was safe and well tolerated, and it may be able to halt the progression of “wet” macular degeneration.
Article

Engineered Heart Tissue Offers Insights Into Arrhythmias
Engineers who have induced heart cells in culture to mimic the properties of the heart have used the tissue to gain new insight into the mechanisms that spawn irregular heart rhythms.
Article

Scientists Spot Solitary Stem Cells in Living Bone Marrow
The ability to study undisturbed blood-forming stem cells in their natural environment will help researchers understand how they work, says U-M scientist.
Article

New Production Protocol to Differentiate Islet Cells from Human Embryonic Stem Cells Introduced
A researcher from Geron presented a new production protocol to differentiate islet cells from human embryonic stem cells (hESC) for the treatment of diabetes at the recently held Stem Cells & Regenerative Medicine Meeting.
Article

Stem Cells From Muscles Can Repair Cartilage
In a study published in the February 2006 issue of Arthritis & Rheumatism, researchers designed a study using muscle-derived stem cells (MDSCs) genetically engineered with a therapeutic protein in an effort to repair articular cartilage defects in rats.
Article

Prions May Hold Key to Stem Cell Function
Researchers at the Whitehead Institute in Cambridge, Massachusetts, US, have now found that adult stem cells in bone marrow gradually lose their ability to regenerate without their normal complement of membrane-bound prions.
Article

Bones From Blood: Scientists Aim To Break New Ground On Fractures
Researchers from the University of York’s Department of Biology are heading the EC-backed project to create bone structures from cord blood stem cells for use in the repair of bone defects and fractures.
Article

New York Mayor Donates Millions to Stem Cell Research
Mayor Michael Bloomberg, a billionaire known for his philanthropy, is behind an anonymous $100 million given Thursday to the Johns Hopkins Institutions that will fund projects including stem cell research and a new children’s hospital center, The Associated Press has learned.
Article

India Opens New Flagship Biotech Hub
A new biotechnology centre, the International Institute of Life Sciences, is to be set up near Hyderabad, India, in an area known as “Genome Valley.” There are currently over 50 biotech companies present at the site, including several multinationals, as well as at the nearby ICICI Knowledge Park, a state-of-the art R&D centre.
Article

Stem Cell Research Boosted By Launch Of Regenerative Medicine Journal
Future Science Group is delighted to announce the launch of its new journal Regenerative Medicine published under the aegis of Senior Editor Dr Stephen Minger of King’s College London. Regenerative Medicine provides a forum to address the important challenges and advances in stem cell research and regenerative medicine, delivering essential information in concise, clear and attractive article formats.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Cartilage Repair Using Bone Morphogenetic Protein 4 and Muscle-Derived Stem Cells
Local delivery of BMP-4 by genetically engineered MDSCs enhanced chondrogenesis and significantly improved articular cartilage repair in rats.
Abstract

An Alternative and Effective HIV Vaccination Approach Based on Inhibition of Antigen Presentation Attenuators in Dendritic Cells
This study demonstrates that SOCS1 functions as an antigen presentation attenuator to control both HIV-1-specific humoral and cellular responses.
Abstract

“The Promise and Pitfalls of Embryonic Stem Cells” (PDF and MP3)
Link

Policy

US State Laws Bypass Research Ban
Washington has effectively put a lid on federal efforts to advance embryonic stem-cell research. But pressure from scientists eager to expand their knowledge, special interest groups searching for new cures for diseases, and those who see a lucrative new biomedical industry has found a relief valve: the nation’s 50 statehouses.
Article

U.K. Panel Seeks Law Change to Allow Tracking Embryo Babies
The U.K.’s Human Genetics Commission wants Parliament to change current law to allow scientists to have access to the identities of children born from screened embryos so they can follow their progress.
Article

Indian Scientists Undeterred by Stem Cell Scandal
Stem cell researchers in India are more cautious in their scientific approach as a result of the South Korean scandal, but are not deterred by it.
Article

Business

OccuLogix Shares Dive on Phase III Failure
OccuLogix stock was body slammed bright and early this morning after the biotech company announced that its therapy for age-related macular degeneration failed to hit its primary endpoint in a Phase III trial. Shares plunged 65 percent on the news.
Article

Medistem Acquires Worldwide Patent Pending Rights to Potential Stem Cell Treatment for a Variety of Cancers; Proprietary Stem Cell Technology has Demonstrated Ability to Trigger Cancer Cells to Behave Like Normal Cells
Medistem Laboratories, Inc. (OTCBB:MDSM)(FWB:S2U), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, announced it has acquired exclusive worldwide rights to a potential treatment for cancer that uses stem cells to reprogram malignant cells to behave like normal cells.
Article

Lifeforce Immune System Bank plc Receives Blood Establishment Authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
Lifeforce® Immune System Bank™ plc has recently received Blood Establishment Authorisation from the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA).
Article

Cobra Signs Contract with Replikun Biotech for Novel Gene Therapy Approach
Cobra Biomanufacturing Plc. (AIM : CBF) has signed a contract with the Australian company Replikun Biotech to support the development of an innovative gene therapy method. Cobra will construct and establish a packaging cell line producing KUN-GMCSF, a potent and novel gene therapy system for the treatment of cancer.
Article

ImmunoGen, Inc. (IMGN) Announces Achievement Of Milestone In Collaboration With Genentech, Inc. (DNA)
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceuticals company that develops targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, today announced that the Company has been informed by Genentech (NYSE: DNA) that the trastuzumab-DM1 Investigational New Drug (IND) application submitted by Genentech to the U.S. Food and Drug Administration (FDA) has become effective.
Article

Biovitrum and Symphogen Enter Co-Development and Commercialization Agreement for Recombinant Polyclonal Antibodies for the Treatment of Certain Blood Disorders
Symphogen A/S, Denmark and Biovitrum AB, Sweden have entered into a co-development and commercialization agreement for Sym001, Symphogen’s lead product.
Article

CyGenics in International Cancer Therapy Collaboration
Leading cell therapy company CyGenics Ltd. (ASX: CYN) announced that it will be part of a new international collaborative effort to develop new treatments for cancer. This will be done via the novel approach of developing and mobilising immune cells outside the human body.
Article

bioMD Acquires 50% Interest In Tissue Engineering Company
The Directors of bioMD Limited are pleased to announce that the Company has finalised an agreement to acquire a 50% equity interest in Celxcel Pty Ltd (“CXC”).
Article

DeveloGen Gets Grant for Beta-cell Regeneration Program
DeveloGen has announced the award of a grant from the Juvenile Diabetes Research Foundation (JDRF) to support development of beta-cell regeneration drugs.
Article

Cambrex Repositions, Considers Strategic Alternatives
Cambrex Corp. (NYSE: CBM) has appointed James A. Mack CEO, and has retained Bear Stearns to help the company consider strategic alternatives, a phrase that often indicates a firm is looking to sell itself or enter into a merger or some other combination.
Article

Dendreon Names Biotech Industry Veteran Mary Coon Vice President of Quality
Ms. Coon will oversee quality assurance of all manufacturing operations, specifically leading the implementation and oversight of quality systems and Good Manufacturing Practices compliance at Dendreon’s new manufacturing facility in East Hanover, N.J.
Article

Medistem Names Veteran Business Process Consultant Chris McGuinn as Vice President and Chief Operating Officer
Medistem Laboratories, Inc. (OTCBB:MDSM) (FWB:S2U), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, announced today that it has named Chris McGuinn, a veteran corporate operations manager with background as a business consultant, process engineer and finance controller, as the Company’s Vice President and Chief Operating Officer.
Article

Biotechnology and Pharmaceutical Industry Veteran to Oversee Manufacturing Operations at Cytovance Biologics
Cytovance Biologics(R) today named Steven D. Perry vice president of manufacturing operations. Perry will oversee the clinical production of biopharmaceuticals at Cytovance’s 44,000 square foot biologics contract manufacturing facility, located in the Presbyterian Health Foundation Research Park in Oklahoma City, Okla.
Article

Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico
Amgen (Nasdaq:AMGN), the world’s largest biotechnology company, today announced that it expects to invest $1 billion over the next four years to expand its manufacturing capacity in Puerto Rico to meet rising global demand for the company’s products.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

Request for Information: Modifications to NHLBI Policy for Distribution of Data from Clinical Trials and Epidemiology Studies (NOT-HL-06-116)
Link

Notice of the NHLBI Program in Computational Modeling for Heart, Lung, Blood, and Sleep Biologists: Introductory Courses (NOT-HL-06-115)
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NHLBI is withdrawing PA-04-028, “Competing Continuation Awards of SBIR Phase II Grants for Heart, Lung, Blood, and Sleep Disorders” (NOT-HL-06-117)
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CBER

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

Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures; Proposed Rule
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Blood Products Advisory Committee Meeting
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Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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Regulatory

Biologics, Radiopharmaceuticals and Genetic Therapies (Health Canada)

Drug/Medical Device Combination Products Policy
Link

ISCT

ISCT2006. May 4-7. Berlin.
Click here for the Call for Abstracts and preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

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

Current Volume: Volume 7, Number 6 / December 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.
http://journalsonline.tandf.co.uk/link.asp?id=107693