Volume 6.51 | Dec 19

Volume 6.51, December 19, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Cloning Pioneer Admitted Fake Data, Partner Says: A doctor who provided human eggs for research by cloning pioneer Hwang Woo-suk said in a broadcast Thursday that the South Korean scientist agreed to withdraw a key research paper because most of the stem cells produced for the article were faked.

UK Full Face Transplant Search On: The approval, given to Dr Butler and his team at north London’s Royal Free Hospital, follows the world’s first partial face transplant in France.


Tiny Self-assembling Cubes Could Carry Medicine, Cell Therapy
“Our group has developed a new process for fabricating three-dimensional micropatterned containers for cell encapsulation and drug delivery,” said David H. Gracias, who led the lab team.

Mice Created With Human Brain Cells
Scientists announced Monday that they had created mice with small amounts of human brain cells in an effort to make realistic models of neurological disorders such as Parkinson’s disease.

Researchers Report ‘Amazing Find’ with Stem Cells
The scientists have found a way to coax stem cells from adult mice to change into brain, nerve, heart and pancreatic cells.

OHSU Discovery Sheds Light into How Stem Cells Become Brain Cells
Continued research could result in new therapies for those who suffer brain injury, Parkinson’s disease and other conditions related to lost or damaged brain cells.

Engineered Stem Cells Show Promise for Sneaking Drugs into the Brain
Writing this week (Dec. 15, 2005) in the journal Gene Therapy, University of Wisconsin-Madison neuroscientist Clive Svendsen and his colleagues describe experiments that demonstrate that engineered human brain progenitor cells, transplanted into the brains of rats and monkeys, can effectively integrate into the brain and deliver medicine where it is needed.

USC Researchers Track Down the Stem Cells that Create Feathers
The stem cells that produce bird feathers have been visualized and analyzed for the first time, signifying the initial step in a scientific journey that may ultimately shed light on human organ regeneration.

Sweden to Establish Biobank of Babies’ Stem Cells
Sweden will set up a national biobank of stem cells collected from babies’ umbilical cords blood after they are born, the government said Thursday.

Gene Test Detects Heart Transplant Rejection
A simple blood test may detect whether a chronic heart transplant patient is rejecting their heart, and may reduce the need for invasive heart-muscle biopsies, according to the results of a multi-center study called CARGO (Cardiac Allograft Rejection Gene Expression Observational Study), led by NewYork-Presbyterian Hospital and Columbia University Medical Center and to be published in the December 19 The American Journal of Transplantation.

Gladstone Researchers Hone in on Differentiation of Heart Stem Cells
A team of scientists from the Gladstone Institute of Cardiovascular Disease (GICD) has identified a key factor in heart development that could help advance gene therapy for treating cardiac disorders.

Standing Up to Paraplegia with Gene Therapy
Elena Rugarli and colleagues from the National Neurological Institute in Milan have used gene therapy to save sensory and skeletal muscle nerve fibers from degeneration in mice with hereditary spastic paraplegia (HSP).

Gene-Therapy Tried for Parkinson’s
It’s a time of mixed excitement and caution: these first three studies are to see if gene therapy is safe to try, not to prove whether it works.

Doctors Take Sides on Face Transplant
Carnival atmosphere, reported suicide attempts by donor and recipient may complicate recovery.

$500,000 to Study Cancer Immunotherapy and Design Patient-Specific Cancer Vaccines
Dr. Carl June, professor of pathology and laboratory medicine at the School of Medicine and director of Translational Research at Penn’s Abramson Cancer Center, was awarded the Bristol-Myers Squibb Company Freedom to Discover Unrestricted Biomedical Research Grant. These five-year grants support pioneering, risk-taking, basic research scientists.


Human Embryonic Stem Cells
Eight prominent scientists in stem cell research argue that questions regarding the validity of recent South Korean stem cell experiments should be resolved not in the press but within the scientific community, and call for the authors of the disputed studies to cooperate with independent tests of the cell lines involved.

Impaired DNA Replication within Progenitor Cell Pools Promotes Leukemogenesis
The demonstration that replication-impaired, poorly competitive progenitor cell pools can promote tumorigenesis provides a new rationale for links between tumorigenesis and common human conditions of impaired DNA replication such as dietary folate deficiency, chemotherapeutics targeting dNTP synthesis, and polymorphisms in genes important for DNA metabolism.


Xcyte Therapies and Invitrogen Announce Signing of Asset Purchase Agreement; Invitrogen to Acquire Xcyte’s T Cell Expansion Technology
Xcyte Therapies, Inc. (Xcyte) (Nasdaq:XCYT) (Nasdaq:XCYTP) and Invitrogen Corporation (Nasdaq:IVGN) today announced they have entered into a definitive agreement for Invitrogen to acquire Xcyte’s T cell expansion technology, known as the “Xcellerate Process.” The acquired assets will include intellectual property, the clinical data generated by Xcyte in the course of six clinical trials of its lead product, Xcellerated T Cells, as well as raw materials and equipment.

Cyclacel and Xcyte Therapies Combine to Form International Biopharmaceutical Company
Cyclacel Group plc (Cyclacel), a privately held corporation, and Xcyte Therapies, Inc. (Xcyte) (Nasdaq:XCYT) (Nasdaq:XCYTP) announced today that they have entered into a definitive agreement to combine the two companies.

Biostem, Inc. Benchmark Coverage To Be Initiated By Investrend Research
Biostem Inc. (OTCBB: BTEM) has enrolled in the unique shareholder empowerment platform administered by Investrend Communications, Inc., a provider of financial intelligence programs. Biostem has announced it is acquiring Cryobanks International, Inc., a leader in the collection, processing, and banking of stem cells derived from the umbilical cord immediately after birth, with a current unrelated (for transplant) cord blood bank inventory of over 8,500 units, plus over 1,000 research units.

Anormed Announces 73 Percent Of Cancer Patients Who Failed Prior Chemotherapy Mobilizations Succeed In Collecting Enough Stem Cells For Transplant In Mozobil Compassionate Use Program
AnorMED (AMEX: AOM, TSX:AOM) announces the first report of clinical results on MOZOBIL (AMD3100), a first in class stem cell mobilizer, from the compassionate use protocol (CUP) in cancer patients requiring a stem cell transplant.

Therakos Selects Memscap for Cell Therapy
MEMSCAP (Euronext: MEN), the leading provider of innovative solutions based on MEMS (micro-electro-mechanical systems) technology, today announces it has been selected by the Photoresis therapy specialist, Therakos, a Johnson&Johnson company. According to the agreement, MEMSCAP will provide its SP854 pressure transducer to Therakos, for integration into their breakthrough Photoresis therapy systems.

Amgen to Acquire Abgenix for $22.50 Per Share; Provides Amgen With Full Ownership of Panitumumab and Eliminates a Denosumab Royalty
Amgen (Nasdaq: AMGN), the world’s largest biotechnology company, and Abgenix, Inc. (Nasdaq: ABGX), a company specializing in the discovery, development and manufacture of human therapeutic antibodies, today announced that they have signed a definitive merger agreement under which Amgen will acquire Abgenix for approximately $2.2 billion in cash plus the assumption of debt.

ImmunoGen, Inc. Announces Genentech Has Taken Fourth License to Use ImmunoGen’s TAP Technology to Develop Novel Anticancer Therapeutics
ImmunoGen, Inc. (Nasdaq: IMGN) today announced that Genentech (NYSE: DNA) has licensed exclusive rights to use ImmunoGen’s Tumor-Activated Prodrug (TAP) technology with therapeutic antibodies to an undisclosed target.

Senesco Technologies Announces Results of Bone Marrow Cancer Cell Line Study Conducted at Mayo Clinic
Senesco Technologies, Inc. (“Senesco” or the “Company”) (AMEX:SNT) today announced results from the Company’s funded research agreement at Mayo Clinic. Using human multiple myeloma cells grown in vitro, the data show that the Company’s proprietary Factor 5A gene technology causes these cancer cells to die, thereby leaving fewer viable cancer cells in comparison to untreated samples.

Long-Term Phase II Follow-Up Data Presented at American Society of Hematology Annual Meeting
Long-term follow-up results from a phase II clinical trial of Genitope Corporation’s (Nasdaq: GTOP) MyVax(R) Personalized Immunotherapy as a treatment for follicular Non-Hodgkin’s Lymphoma (f-NHL) after chemotherapy shows a significant increase in time-to-progression of f-NHL compared to chemotherapy alone. Study findings were presented during a poster session at the 47th Annual Meeting of the American Society of Hematology in Atlanta.

BrainStorm Makes Progress Towards Human Stem Cell Therapy for Parkinson’s — Animal Model Shows Long-Term Benefit
BrainStorm Cell Therapeutics (OTCBB:BCLI), the developer of NurOwn(TM) bone marrow derived stem cell therapeutic products for the treatment of Parkinson’s and other neurodegenerative diseases, announced today the results of a follow-up preclinical study evaluating the long-term impact of the company’s dopaminergic cell treatment for Parkinson’s disease.



Registration Open for January 11 Training Sessions on NIH’s New Electronic Grant Application Process and the SF424 (R&R) (NOT-OD-06-021)


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

Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Final Rule and Final Order

Substantially Equivalent 510(k) Device – UltraChek Reference Controls – Product Code GLK; UltraCrit Hematocrit Measurement Device – Product Code GKF – Separation Technology, Inc


Food & Drug Administration (United States of America)

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Medsafe (Australia/ New Zealand)

Steady progress toward the Australia New Zealand Therapeutic Products Authority
The New Zealand Minister of State Services, Annette King and Australia’s Parliamentary Secretary for Health, Christopher Pyne met in Canberra last week to review the steady progress being made to establish a joint therapeutic products regulatory scheme.


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

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.

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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!

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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 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.

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