Volume 9.07 | Feb 25

Cell Therapy News 9.07, February 25, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Trial for Aggressive Brain Cancer: Human trials are about to start of a form of gene therapy that shows great promise in treating one of the worst kinds of cancer.
Article

Scientists Move Towards Stem Cell Therapy Trials to Mend Shattered Bones: Scientists are developing a revolutionary way to mend damaged bones and cartilage using a patient’s own stem cells.
Article

Science

StemCell Technologies’ Contract Services Presents Educational Webinar on Erythropoietin (EPO) Signaling and Erythroid Development
“A guide to erythropoiesis: EPO signaling and erythroid development” will be presented by Dr. Jackie Damen on March 12, 2008 at 11:00 AM PST.
Link

Discovery Could Help Reprogram Adult Cells To Embryonic Stem Cell-like State
In a paper released online by the journal Cell Stem Cell, researchers report that they have discovered how long adult cells need to be exposed to reprogramming factors before they convert to an embryonic-like state, and have “defined the sequence of events that occur during reprogramming.”
Article

Novocell Reports Successful Use of Stem Cells to Generate Insulin in Mice
Novocell, Inc. has announced data demonstrating for the first time that human embryonic stem (hES) cells can be turned into pancreatic cells capable of producing insulin in mice
Article

Advanced Cell Technology Demonstrates Efficient Generation of Functional Hepatocytes From Human Embryonic Stem Cells
Advanced Cell Technology, Inc. has reported for the first time a robust and highly efficient process for the generation of high-purity hepatocytes.
Article

Reprogramming Cells Taken from Disease Sufferers Could Lead to New Treatments
The discovery late last year of a way to generate stem cells from adult skin cells could allow scientists to study disease in unprece­dented detail, from earliest inception to final biochemi­cal demise. That’s because the stem cells could be used to develop cell lines derived from people with a given disease-neurons from Alzheimer’s patients, for example, or blood cells from people with sickle cell anemia.
Article

Stem Cell Jabs Reverse Damage After Strokes, Doctors Claim
Hopes that a therapy may be on the horizon were boosted by experiments which showed human embryonic stem cells could be turned into a variety of brain cells, which helped animals recover from strokes without causing dangerous side effects.
Article

New Acute Lung Injury Study Finds Benefits of Autologous Cell Transplantation Therapy
A study published in this month’s Anesthesiology highlights the potential of cell-based therapies for the treatment of acute lung injury and acute respiratory distress syndrome.
Article

Gene Therapy ‘Trains’ Immune System To Destroy Brain Cancer Cells And Reverses Behavioral Deficits
A new gene therapy approach that attracts and “trains” immune system cells to destroy deadly brain cancer cells also provides long-term immunity, produces no significant adverse effects and – in the process of destroying the tumor – promotes the return of normal brain function and behavioral skills.
Article

Tumor-killing Virus Selectively Targets Diseased Brain Cells
New findings show that a specialized virus with the ability to reproduce its tumor-killing genes can selectively target tumors in the brains of mice and eliminate them.
Article

Emory Begins Testing New Alzheimer’s Disease Vaccine
Doctors at Emory University will begin testing a vaccine designed to slow the accumulation of amyloid plaques in the brains of patients with Alzheimer’s disease.
Article

Phase I and Phase I/II DCVax(R)-Brain Data Continues to Show Significantly Improved Survival Rates for Brain Cancer Patients
Northwest Biotherapeutics, Inc. has announced the most recent long-term follow-up data, as of year-end 2007, on disease progression and overall survival in patients taking part in its Phase I and Phase I/II clinical trials for newly diagnosed patients with Glioblastoma multiforme, the most aggressive form of brain cancer
Article

Cell-Enhanced Breast Reconstruction Study Shows Sustained Improvement at 12-Months
Cytori Therapeutics was informed that positive longer-term follow-up data were presented today from an independent, investigator-sponsored breast reconstruction study in Japan. As part of the study, adipose tissue-derived stem and regenerative cells, processed with Cytori’s Celution(TM) 600 System, were used to reconstruct breast tissue following partial mastectomy.
Article

Introgen’s p53 Immunotherapy INGN 225 Begins Randomized, Controlled Clinical Trial in Patients with Small Cell Lung Cancer
The controlled, randomized phase 2 trial, which will be led by Principal Investigator Dr. Alberto Chiappori, in the Department of Interdisciplinary Oncology at Moffitt, will evaluate the efficacy and safety of INGN 225 in as many as 80 patients with extensive stage SCLC at multiple centers.
Article

$150,000 for a Pet Dog, Just Like Your Last One
A Californian dog-lover has agreed to pay $150,000 to have her dead pit bull recreated in the world’s first commercial pet cloning project.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Prospects for Stem Cell-Based Therapy
Resident pools of somatic stem cells in many organs are responsible for tissue maintenance and repair. The goal of regenerative medicine is to exploit these cells either by transplanting them from an exogenous source or by activating endogenous stem cells pharmacologically. For diseases caused by mutations in a single gene, the therapeutic goal is tissue replacement using stem cells engineered to correct the genetic defect. However, a number of technical hurdles must be overcome before therapies based on pluripotent human stem cells can enter the clinic.
Abstract

Stem Cell Biotech: Seeking a Piece of the Action
Venture capital groups and big pharma have largely held back from investing in biotech companies focused on regenerative medicine. Will it take a clinical bull’s eye to bring venture capitalists and big pharma into the cell therapy arena?
Abstract

JOB OPPORTUNITIES

Cell Therapy Business Development Leader
Portland, OR (Invitrogen)
Link

Policy

Bill Takes Aim at CIRM Governance, Stem Cell Research Payback
California Senator Sheila Kuehl introduced a bill Friday to study the structure of the California Institute for Regenerative Medicine and to require therapies from the research to help the state’s neediest residents.
Article

Proposed Pay Hikes for Stem Cell Executives are Too High, Panel Says
Citing the need to show fiscal restraint as California’s budget deficit mounts, a subcommittee Wednesday recommended trimming a proposal to increase the top salary range for executives and lead lawyers at the state’s stem cell agency.
Article

Maryland Weighs Tabling Stem Cell Funding
Legislative analysts are recommending that the Maryland General Assembly temporarily suspend new funding for stem cell research grants, a move that would save $23 million next year.
Article

Business

Mesoblast Announces Heart Therapy Agreement with Abbott
Mesoblast Ltd has announced that its US-based sister company, Angioblast Systems Inc, has entered into a collaborative agreement with Abbott for the development and commercialisation of Angioblast’s catheter-based cell therapy product for heart failure.
Article

Families of Spinal Muscular Atrophy; University of California, Irvine Stem Cell Scientist; and California Stem Cell Announce Collaboration for Safety Studies for Stem Cell Therapy in Spinal Muscular Atrophy
The specific set of animal studies planned, which will be conducted in accordance with FDA regulations, will assess the safety of motor neuron progenitors derived from human stem cells after transplantation.
Article

Neuralstem Inc. Announces Strategic Investment by Korean CJ CheilJedang Corporation
Neuralstem, Inc. announces that Korean conglomerate, CJ CheilJedang Corporation has purchased an option to negotiate for the exclusive license to Neuralstem’s stem cell-products and technology after the company completes a successful human clinical trial.
Article

MolMed Seeking $106M in IPO to Boost Cell Therapy Phase III
One month after receiving a green light to move its cell therapy treatment for improving the outcomes of hematopoietic stem cell transplants into a Phase III clinical trial, MolMed SpA. is launching an initial public offering in which it is seeking up to US$105.8 million.
Article

Bioheart Announces Pricing of Initial Public Offering and Commencement of Trading
Bioheart, Inc. has announced the pricing of its initial public offering of 1,100,000 shares of common stock at a price of $5.25 per share. All of the shares are being offered by Bioheart. Bioheart’s common stock commenced trading on the NASDAQ Global Market under the trading symbol “BHRT” on February 19, 2008.
Article

Start Licensing, Inc. Challenges Korean Company’s Provision of Dog Cloning Services
The patent licensee will take legal action to protect rights if necessary.
Article

ImmunoCellular Therapeutics Announces New President and Chief Executive Officer
ImmunoCellular Therapeutics, Ltd. has announced that Manish Singh, Ph.D., MBA has taken on the full-time position of President and Chief Executive Officer of the Company.
Article

NIH

Pre-Application Meeting for RFA-OD-08-001 and RFA-OD-08-002, Rare Diseases Clinical Research Network (NOT-OD-08-042)
Link

National Cancer Institute (NCI) Initiatives for Support of Basic and Translational Tumor Stem Cell Research (NOT-CA-08-010)
Link

Tumor Stem Cells in Cancer Biology, Prevention, and Therapy (R01) (RFA-CA-08-019)
Link

Administrative Supplements for Making Knockout Mice (NOT-HG-08-002)
Link

Small Grants for Lung Tissue Research (R03) (RFA-HL-08-008)
Link

CBER

Approved Biological NDA and ANDA Applications – Update
Link

Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
Link

Recall of Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules
Link

Recall of ThermoGenesis AXP Bag Sets 8-5101
Link

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

Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability
Link

Heparin Recall May Prompt Inspection Law
When federal regulators failed to inspect a Chinese factory at the center of a massive drug recall, they didn’t break any laws. That legal vacuum has members of Congress asking if laws are needed to make sure the Food and Drug Administration follows its own regulations for inspecting foreign facilities.
Article

ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: http://www.celltherapysociety.org



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