Volume 12.12 | Mar 28

Cell Therapy News 12.12, March 28, 2011.
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events

Researchers Uncover Novel Immune Therapy for Pancreatic Cancer
Researchers have discovered a novel way of treating pancreatic cancer by activating the immune system to destroy the cancer’s scaffolding. [Press release from the University of Pennsylvania School of Medicine discussing online prepublication in Science]


Researchers Sequence Multiple Myeloma Genome in Landmark Nature Study
Using new genome sequencing technologies, researchers published the first complete genomic portrait of multiple myeloma. [Press release from the Hackensack University Medical Center discussing online prepublication in Nature]

New Data Published in Nature Genetics Demonstrate That Tiny LNA-Based Compounds Developed by Santaris Pharma A/S Inhibit Entire Disease-Associated MicroRNA Families
A study demonstrates that tiny Locked Nucleic Acid (LNA)-based compounds can inhibit entire disease-associated microRNA families. [Press release from Santaris Pharma A/S discussing online prepublication in Nature Genetics]

Stem Cells May Be Key to Understanding the Origins of Colon Cancer and Detecting Relapse
Colorectal cancer cells trigger a set of genes similar to those found in intestinal stem cells, scientists have found. [Press release from the Institute for Research in Biomedicine discussing online prepublication in Cell Stem Cell]

NIH Study Identifies Gene That Suppresses Cell’s Immune Activation
A new study of prostate tumors has shown that a gene, FOXO3, suppresses activation of cells related to immunity and thus leads to a reduced immune response against a growing cancer. [Press release from the National Institutes of Health discussing online prepublication in the Journal of Clinical Investigation]

Making Cells on an Assembly Line
Researchers have developed a chip-based method that creates uniformly sized vesicles in assembly-line fashion. Sized between 20 and 70 micrometers in diameter, the vesicles are large enough to be loaded with DNA and the biochemical machinery to act as synthetic cells. [Press release from MIT Technology Review discussing online prepublication in the Journal of the American Chemical Society]

Cancer Drug Shows Promise for Treating Scleroderma
A drug approved to treat certain types of cancer has shown promising results in the treatment of patients with scleroderma, according to results from an open-label Phase II trial. [Press release from ScienceDaily discussing online prepublication in the Annals of the Rheumatic Diseases]

Stem Cells May Show Promise for People with Rapidly Progressing MS
A long term study reports about the effectiveness of replacing bone marrow, purposely destroyed by chemotherapy, with autologous stem cell rescue for people with aggressive forms of multiple sclerosis (MS). [Press release from the American Academy of Neurology discussing online prepublication in Neurology]

Stem Cell Therapy for Age-Related Macular Degeneration – A Step Closer to Reality
Researchers have demonstrated, for the first time, the ability to create retinal cells derived from human-induced pluripotent stem cells that mimic the eye cells that die and cause loss of sight. [Press release from Georgetown University Medical Center discussing online prepublication in Stem Cells]

Experimental Radioprotective Drug Safe for Lung Cancer Patients, Says University of Pittsburgh Cancer Institute Study
Patients with advanced non-small cell lung cancer can safely take an experimental oral drug intended to protect healthy tissue from the effects of radiation. [Press release from the University of Pittsburgh Cancer Institute discussing online prepublication in Human Gene Therapy]

Deadly Glioblastoma Target for Immunotherapy Research
Baylor College of Medicine researchers at Texas Children’s Cancer Center and their collaborators at The Methodist Hospital have launched two Phase I clinical studies using immunotherapy to treat glioblastoma multiforme, the most aggressive type of brain cancer in both children and adults. [Baylor College of Medicine Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Initial Genome Sequencing and Analysis of Multiple Myeloma
Multiple myeloma is an incurable malignancy of plasma cells, and its pathogenesis is poorly understood. Here researchers report the massively parallel sequencing of 38 tumor genomes and their comparison to matched normal DNAs. [Nature]

Silencing of MicroRNA Families by Seed-Targeting Tiny LNAs
Data support the utility of tiny locked nucleic acids (LNAs) in elucidating the functions of microRNA families in vivo. [Nat Genet]

CD40 Agonists Alter Tumor Stroma and Show Efficacy Against Pancreatic Carcinoma in Mice and Humans
Cancer immune surveillance does not necessarily depend on therapy-induced T cells; rather, findings demonstrate a CD40-dependent mechanism for targeting tumor stroma in the treatment of cancer. [Science]

The Intestinal Stem Cell Signature Identifies Colorectal Cancer Stem Cells and Predicts Disease Relapse
Data suggest that the intestinal stem cell program defines a cancer stem cell niche within colorectal tumors and plays a central role in colorectal cancer relapse. [Cell Stem Cell]

FOXO3 Programs Tumor-Associated DCs to Become Tolerogenic in Human and Murine Prostate Cancer
Findings demonstrate that FOXO3 may play a critical role in mediating tumor-associated DC-induced immune suppression. [J Clin Invest]

Stepwise Synthesis of Giant Unilamellar Vesicles on a Microfluidic Assembly Line
Researchers report a microfluidic assembly line that produces uniform cellular compartments from droplet, lipid, and oil/water interface starting materials. [J Am Chem Soc]

Long-Term Results of Stem Cell Transplantation for MS: A Single-Center Experience
Hematopoietic stem cell transplantation is not a therapy for the general population of patients with multiple sclerosis (MS) but should be reserved for aggressive cases, still in the inflammatory phase of the disease, and for the malignant form, in which it can be life-saving. [Neurology]

Human iPS-Derived Retinal Pigment Epithelium (RPE) Cells Exhibit Ion Transport, Membrane Potential, Polarized VEGF Secretion and Gene Expression Pattern Similar to Native RPE
Researchers show for the first time that RPE generated from human induced pluripotent stem (iPS) cells under defined conditions exhibit ion transport, membrane potential, polarized VEGF secretion and gene expression profile similar to those of native RPE. [Stem Cells]



U.K. Unearths £100 Million More for Research Infrastructure, Launches Agency to Eliminate Clinical Trial Red Tape
The United Kingdom’s budget for 2011-12, announced by Chancellor of the Exchequer George Osborne, has some good news for scientists with a £100 million boost in spending on capital projects as well as promised removal of red tape surrounding biomedical research and clinical trials. [Her Majesty’s Treasury, United Kingdom]

China Hints at Science-Funding Reform
In his annual report to China’s top legislature at the National People’s Congress in Beijing earlier this month, Premier Wen Jiabao highlighted the need for government science funding to be allotted and spent more efficiently – raising the hopes of Chinese researchers that the funding system will soon be overhauled. [National People’s Congress, China]

Akron Plans Biomedical Seed Fund to Attract Startups to City
The city of Akron is planning to create a seed fund that’s aimed at attracting out-of-region biomedical companies to the city and helping local startups grow. [City of Akron, United States]



Cellular Dynamics International and Roche Transition Early Access Collaboration into a Standard Supply Agreement Ahead of Schedule
Cellular Dynamics International (CDI) announced that their two-year collaboration with Roche to substantiate CDI’s iCell® Cardiomyocytes as a predictive tool for assessing the potential cardiotoxic effects of developing drug candidates was completed early and is now transitioning into a standard supply agreement. [Cellular Dynamics International Press Release]

Stem Cell Agencies for California and India Sign Agreement to Fund Collaborative Research Projects That Can Accelerate Regenerative Medicine Toward Therapies
The California Institute for Regenerative Medicine and the Institute for Stem Cell Biology and Regenerative Medicine have signed a Memorandum of Understanding that outlines ways the two agencies can jointly fund collaborative research projects that bring together top stem cell scientists in California and top stem cell scientists in India. [California Institute for Regenerative Medicine Press Release]

CIRM Signs Agreement with France – As the French Debate the Ethics of Stem Cell Science
The California Institute for Regenerative Medicine (CIRM) has signed a collaborative agreement on stem cell research with the French Government’s Agence Nationale de la Recherche. [California Institute for Regenerative Medicine Press Release]

Cephalon Announces Definitive Agreement to Acquire Gemin X
Cephalon, Inc. announced that it has signed a definitive merger agreement under which it will acquire all of the outstanding capital stock of Gemin X Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing first-in-class cancer therapeutics, for $225 million cash on a cash-free, debt-free basis. [Cephalon, Inc. Press Release]

Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Abbott
Seattle Genetics, Inc. announced that it has entered into a collaboration agreement with Abbott under which Abbott will pay an upfront fee of $8 million for rights to utilize Seattle Genetics’ antibody-drug conjugate technology with antibodies to a single oncology target. [Seattle Genetics, Inc. Press Release]

Bellicum Pharmaceuticals Awarded $5.7 Million by the Cancer Prevention and Research Institute of Texas
Bellicum Pharmaceuticals, Inc. announced that the Company received notice of a $5.7 million company commercialization award from the Cancer Prevention and Research Institute of Texas. The award will fund personnel, manufacturing, and clinical testing of Bellicum’s CaspaCIDe™ therapy, which promises to substantially improve outcomes for late stage cancer patients. [Bellicum Pharmaceuticals Press Release]

MethylGene Raises $34.5 Million
Montreal cancer drug developer MethylGene Inc. is raising $34.5 million in a private placement of shares and warrants that will provide sufficient capital to advance its two primary product candidates to Phase II clinical trials. [Montreal Gazette]

UA Wins $11.8 Million NIH Contract to Study Immunity in Elderly
The University of Arizona (UA) department of immunobiology and the Arizona Center on Aging have won a five-year, $11.8 million contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), to study declining immunity among the aging. [University of Arizona Press Release]

Massachusetts Life Sciences Center Board Approves 2011 Accelerator Program Loans for Early-Stage Companies
The Massachusetts Life Sciences Center announced the awarding of $3.75 million in loans to five early-stage life sciences companies. [Massachusetts Life Sciences Center Press Release]

ACT to Be Issued Broad Patent for Human ES Cell-Derived RPE Cells in China
Advanced Cell Technology, Inc. (ACT) announced that China’s State Intellectual Property Office has allowed the Company’s patent application to provide broad intellectual property protection in China for the manufacturing and pharmaceutical preparations of retinal pigment epithelial (RPE) cells from human embryonic stem (ES) cells. [Advanced Cell Technology, Inc. Press Release]

Pluristem to Develop Stem Cell Therapy on Its Own: CEO
Pluristem Therapeutics Inc. said it will go solo in developing its stem cell therapy to treat severe obstruction of arteries that can lead to amputation, but will look for a marketing partner to launch the therapy. [Reuters]

ReGen Response to FDA 24 Hour Summary of March 23, 2010 Panel Meeting
Subsequent to the March 23, 2010 Orthopedic and Rehabilitation Devices Panel meeting to discuss ReGen Biologics, Inc.’s collagen scaffold device, FDA published a 24-hour summary of the panel recommendations. However, FDA’s summary does not accurately reflect the panel’s discussion. [ReGen Biologics, Inc. Press Release]

MUSC Spin-Off Receives Two Wound-Healing Patents
FirstString Research, Inc., a biotechnology company sprung from a Medical University of South Carolina (MUSC) lab, has received two patents for intellectual property protection for further development and commercialization of its regenerative medicine technology. [PR Newswire]

Q&A With Australia-Bound Stem Cell Ace
Martin Pera of the University of Southern California announced that he will return to Australia to lead Stem Cells Australia, a new national stem cell consortium. [ScienceInsider]

NYU Langone Medical Center Physician Honored by the Israel Cancer Research Fund
Daniel F. Roses, MD, the Jules Leonard Whitehill Professor of Surgery and Oncology and chief of the Division of Surgical Oncology at NYU Langone Medical Center was awarded the Tower of Hope Dr. Daniel G. Miller Excellence in Medicine Award by the Israel Cancer Research Fund. [New York University Langone Medical Center Press Release]

Ching-Hon Pui, M.D., Recognized with American Association for Cancer Research Award
Ching-Hon Pui, M.D., a world renowned leukemia physician and researcher at St. Jude Children’s Research Hospital, is the recipient of the 2011 Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Research from the American Association for Cancer Research. [St. Jude Children’s Research Hospital Press Release]

Oxford BioMedica Board Changes
Oxford BioMedica plc announced that by mutual agreement, its Chairman, Dr. Alan Kingsman, will leave the Board of Oxford BioMedica at the Company’s forthcoming Annual General Meeting on 5 May 2011. [Oxford Biomedica plc Press Release]

Tengion Announces Addition of Two Renal Experts to Research & Development Advisors Panel
Tengion, Inc. announced the addition of two renal research and clinical experts, Ben Humphreys, M.D., Ph.D. and Giuseppe Remuzzi, M.D., F.R.C.P., from the Harvard Stem Cell Institute and Mario Negri Institute respectively, to its panel of Research & Development Advisors. [Tengion, Inc. Press Release]

New Stanford Nano Center Provides State-of-the-Art Equipment for Research at the Smallest of Scales
The Stanford Nano Center, along with the existing Nanofabrication Facility and Nanocharacterization Laboratory, will upgrade the university’s nanotechnology facilities to rank among the best in the world. [Stanford University Press Release]

Two New Basic Science Departments Established
The University of Wisconsin School of Medicine and Public Health has created two new basic science departments – the Department of Neuroscience and the Department of Cell and Regenerative Biology. [University of Wisconsin School of Medicine and Public Health Press Release]

Cancer Research and the $90 Billion Metaphor
Although the “War on Cancer” metaphor has been a target for skeptics, who note that cancer incidence and mortality rates haven’t changed fundamentally, if one sets aside the rhetoric, it’s evident that the cancer campaign has changed therapy and saved lives, as demonstrated in this infographic Science has created of indicators for the seven deadliest cancers. [Science]


Systems Approach to Immunity and Inflammation (U19) (RFA-AI-11-017)

Limited Competition for Competitive Revision Applications to Accelerating and Enhancing Collaborative Translational Science (UL1) (RFA-RR-11-004)

Translation of Pluripotent Stem Cell Therapies for Blood Diseases (R01) (PA-11-186)

Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (Parent T32) (PA-11-184)

Ruth L. Kirschstein National Research Service Award Short-Term Institutional Research Training Grants (Parent T35) (PA-11-185)

High-Throughput-Enabled Structural Biology Partnerships (U01) (PAR-11-176)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-7193)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-6861)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-6860)

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting (FR Doc. 2011-6748)

National Center for Research Resources; Notice of Closed Meeting (FR Doc. 2011-7137)


April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Briefing Document: Use of Serum Bactericidal Antibody as an Immunological Correlate for Demonstrating Effectiveness of Meningococcal Conjugate Vaccines (Serogroups A, C, Y, W-135) Administered to Children Less Than 2 Years of Age

April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Briefing Document: Approaches to Licensure of Meningococcal Vaccines for Prevention of Serogroup B Invasive Meningococcal Disease

April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda


FDA Approves New Treatment for a Type of Late-Stage Skin Cancer
The U.S. Food and Drug Administration approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
The Food and Drug Administration (FDA) approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age.

Drugmakers Slow to Confirm Cancer Drugs Work May Face FDA Fines
Drugmakers such as Pfizer Inc. that win early U.S. approval of promising cancer treatments may face fines up to $10 million if they take too long to confirm effectiveness in follow-up studies, Food and Drug Administration officials said.


EU Clinical Trials Register Goes Live
The EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/) was launched by the European Medicines Agency.

European Medicines Agency Closes PIM Project
The European Medicines Agency (EMA) announced the closure of the PIM, or the Product Information Management, project.

European Medicines Agency Launches Survey to Gather Feedback on SME Program
The European Medicines Agency has launched a new online survey to gather feedback from stakeholders on its small and medium-sized enterprise (SME) program.

Second Phase of Public SME Register Goes Live
The European Medicines Agency has launched the second phase of the public SME register.


Biologicals Framework (Updated)


NEW World Pharmacokinetics/ Pharmacodynamics Summit
April 26-29, 2011
Boston, United States

NEW Allicense 2011: A New Deal for Biotech
May 3-4, 2011
San Francisco, United States

NEW European Pharma Manufacturing Masters 2011
May 9-10, 2011
Berlin, Germany

NEW 10th Annual Recombinant Antibodies
May 24-26, 2011
Barcelona, Spain

NEW Cancer Proteomics 2011 – Systems Biology, Developmental  Models & Data Integration
June 20-23, 2011
Dublin, Ireland

NEW Cell Symposia: Epigenetics and the Inheritance of Acquired States
October 30-November 1, 2011
Boston, United States

our events page to see a complete list of events in the cell, gene and immunotherapy community.


Lab Technologist – Human Embryonic and Induced Pluripotent Stem Cells (STEMCELL Technologies)

Implementation Coordinator – Maternity Leave Contract (STEMSOFT Software Inc.)

Postdoctoral Research Position – Mucosal Immunology (Department of Microbiology and Immunology, Columbia University)

Postdoctoral Position – Vascular Smooth Muscle Biology (Boston University Medical School)

Supervisor Cell Therapy Laboratory – Cord Blood Bank (The University of Texas MD Anderson Cancer Center)

Supervisor Cell Therapy Lab (The University of Texas MD Anderson Cancer Center)

Postdoctoral Position (Johns Hopkins University School of Medicine)

Manager Clinical Affairs (Bioheart, Inc.)

Quality Assurance Specialist – Gene Transfer & Somatic Cell Engineering Facility (Memorial Sloan-Kettering Cancer Center)

Postdoctoral Position – Germline Stem Cells (R. L. Brinster, School of Veterinary Medicine, University of Pennsylvania)

Scientific Director (Adipose Derived Stem Cell Bank)

Process Technical Development Scientist (StemCells, Inc.)

Field Applications Specialist – Cell Therapy (Medical) (Pall Corporation)
Postdoctoral Positions – Stem Cell Biology (Joslin Diabetes Center/Harvard Stem Cell Institute)
Cell Therapy Manufacturing Manager (Opexa Therapeutics)

Assistant Professor (University of Pittsburgh School of Medicine, Center for Cellular and Molecular Engineering)

Special Assistant to the Director (Center for Biologics Evaluation and Research)

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