Volume 11.21 | Jun 7

Cell Therapy News 11.21, June 7, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe


TOP STORY


McGill Team Discovers a Piece of the Puzzle for Individualized Cancer Therapy via Gene Silencing
Researchers have discovered that a small segment of a protein that interacts with RNA can control the normal expression of genes – including those that are active in cancer. [Press release from McGill University discussing online prepublication in Nature]

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SCIENCE NEWS


Investigational Compound Ipilimumab Demonstrates Improved Overall Survival in Phase III Trial of Previously-Treated Patients with Metastatic Melanoma
Bristol-Myers Squibb Company announced positive results from a Phase III randomized, double blind study of ipilimumab which demonstrated that overall survival was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab. [Press release from Bristol-Myers Squibb Company discussing online prepublication in the New England Journal of Medicine]

SPRYCEL® (Dasatinib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to Gleevec® in Study of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced Phase III study results in which SPRYCEL (dasatinib) 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response compared to Gleevec® (imatinib mesylate). [Press release from Bristol-Myers Squibb Company discussing online prepublication in the New England Journal of Medicine]

New Data Show Novartis Drug Tasigna® Surpasses Glivec® in Slowing Disease Progression for Newly Diagnosed CML Patients
Novartis announced 18-month results (median follow-up) showing that Tasigna® (nilotinib) significantly surpasses Glivec® (imatinib) in slowing disease progression in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. [Press release from Novartis AG discussing online prepublication in the New England Journal of Medicine]

Study Finds New Pattern in DNA Methylation, with Implications for Cancer, Stem Cell Lines
Using high-throughput DNA sequencing to study sites on DNA where high levels of methylation occur, a team of scientists discovered a relationship between methylation and the positioning of nucleosomes, which compact and regulate access to DNA in the nucleus of a cell. [Press release from the University of California, Los Angeles discussing online prepublication in Nature]

Faulty Gene Stops Cell ‘Antennae’ From Transmitting
An international group of researchers has identified the genetic cause of an inherited condition that causes severe fetal abnormalities. [Press release from the University of California, San Diego discussing online prepublication in Nature Genetics]

Cleveland Clinic Researchers Develop Prototype Vaccine to Prevent Breast Cancer
A first-of-its-kind vaccine to prevent breast cancer has shown overwhelmingly favorable results in animal models.  [Press release from the Cleveland Clinic's Lerner Research Institute discussing online prepublication in Nature Medicine]

Study of MicroRNA Helps NIH Scientists Unlock Secrets of Immune Cells
Researchers looked at mouse immune cells and examined the types, amount, and activity of microRNAs, genetic components that help regulate the production of proteins. [Press release from the National Institutes of Health discussing online prepublication in Immunity]

Immune System Helps Transplanted Stem Cells Navigate in Central Nervous System
By discovering how adult neural stem cells navigate to injury sites in the central nervous system, researchers have helped solve a puzzle in the creation of stem cell-based treatments: How do these cells know where to go? [Press release from the University of California, Irvine discussing Proceedings of the National Academy of Sciences USA]

Idera Pharmaceuticals Announces Publication of Preclinical Data on Cancer Immunotherapy with its Dual Agonist of Toll-like Receptors 7 and 8
Idera Pharmaceuticals, Inc. announced the publication of data from studies of a dual agonist of Toll-like Receptor 7 (TLR7) and TLR8 in preclinical models of cancer. [Press release from Idera Pharmaceuticals, Inc. discussing online prepublication in Molecular Cancer Therapeutics]

Blocking DNA Repair Protein Could Lead to Targeted, Safer Cancer Therapy
Researchers at the University of Pittsburgh Cancer and the School of Medicine have discovered that inhibiting a key molecule in a DNA repair pathway could provide the means to make cancer cells more sensitive to radiation therapy while protecting healthy cells. [Press release from the University of Pittsburgh discussing online prepublication in Science Signaling]

Alnylam Presents Preliminary Phase I Data at American Society of Clinical Oncology Meeting for ALN-VSP, an RNAi Therapeutic for the Treatment of Liver Cancers
Alnylam Pharmaceuticals, Inc. announced preliminary clinical data from its ongoing Phase I trial with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement. [Press release from Alnylam Pharmaceuticals, Inc. discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

New Non-Small Cell Lung Cancer Drug Creates Stir
Crizotinib, an inhibitor of anaplastic lymphoma kinase has demonstrated the ability to shrink tumors in about 90% of patients with advanced non-small cell lung cancer. [Press release from MedPage Today discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

Green Tea Extract Appears to Keep Cancer in Check in Majority of CLL Patients
An extract of green tea appears to have clinical activity with low toxicity in chronic lymphocytic leukemia (CLL) patients who used it in a phase II clinical trial. [Press release from the Mayo Clinic discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

Experimental Targeted Therapy Shows Early Promise Against Medulloblastomas – A Type of Childhood Brain Cancer
Researchers report the findings of a pediatric brain tumor study using an experimental drug that targets the underlying genetic makeup of the tumor. [Press release from St. Jude Children’s Research Hospital discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

NewLink Genetics' HyperAcute® Immunotherapy Phase II Study Shows Promise in Disease Free and Overall Survival for Resectable Pancreatic Cancer
NewLink Genetics Corporation announced positive Phase II clinical trial data of its HyperAcute®-Pancreas cancer immunotherapy combined with standard adjuvant chemotherapy in patients with surgically resectable pancreatic cancer. [Press release from PR Newswire discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

Advanced Phase I and Phase II Studies of Targeted Gene Delivery Confirm That Rexin-G Impacts Survival in Chemotherapy-resistant Bone and Soft Tissue Sarcoma
The goals of the study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in chemo-therapy-resistant bone and soft tissue sarcoma. [Press release from Epeius Biotechnologies Corporation discussing research presented at the 46th Annual Meeting of the American Society of Clinical Oncology]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Ipilimumab, with or without a glycoprotein 100 (gp100) peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. [N Engl J Med]

Dasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Dasatinib, administered once daily, as compared with imatinib, administered once daily, induced significantly higher and faster rates of complete cytogenetic response and major molecular response. [N Engl J Med]

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia
Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia. [N Engl J Med]

Relationship Between Nucleosome Positioning and DNA Methylation
Researchers report a genome-wide nucleosome positioning analysis of Arabidopsis thaliana using massively parallel sequencing of mononucleosomes. [Nature]

Structural Basis for 5'-Nucleotide Base-Specific Recognition of Guide RNA by Human AGO2
This study provides structural evidence for nucleotide-specific interactions in the middle domain of eukaryotic Argonaute proteins (AGOs) and explains the observed preference for U or A at the 5' end of miRNAs. [Nature]

Mutations in TMEM216 Perturb Ciliogenesis and Cause Joubert, Meckel and Related Syndromes
Joubert syndrome (JBTS), related disorders and Meckel syndrome (MKS) are ciliopathies. Researchers now report that MKS2 and CORS2 (JBTS2) loci are allelic and caused by mutations in TMEM216, which encodes an uncharacterized tetraspan transmembrane protein. [Nat Genet]

An Autoimmune-Mediated Strategy for Prophylactic Breast Cancer Vaccination
Alpha-lactalbumin vaccination may provide safe and effective protection against the development of breast cancer for women in their post-child-bearing, premenopausal years, when lactation is readily avoidable and risk for developing breast cancer is high. [Nat Med]

Regulation of MicroRNA Expression and Abundance During Lymphopoiesis
Data provide a comprehensive map of immunity's microRNome and reveal the underlying epigenetic and transcriptional forces that shape miRNA homeostasis. [Immunity]

Peripheral Transvenular Delivery of Adeno-Associated Viral Vectors to Skeletal Muscle as a Novel Therapy for Hemophilia B
Researchers adapted an intravascular delivery system of adeno-associated viral vectors encoding the factor IX transgene to skeletal muscle of hemophilia B dogs. [Blood]

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POLICY


Obama Nominates Suresh to Lead NSF
President Barack Obama has chosen Massachusetts Institute of Technology Engineering (MIT) Dean Subra Suresh to be the next director of the National Science Foundation (NSF). [National Science Foundation, United States]

Treasury Releases New Guidance for Tax Credit in Affordable Care Act to Support Groundbreaking Biomedical Research
The U.S. Department of the Treasury announced the guidelines for applying for the new Therapeutic Discovery Project Program created by the Affordable Care Act. [Department of the Treasury, United States]

Gene Test Hope for Personalized Cancer Therapy
National Health Service patients are to be offered personalised cancer treatment under a pilot scheme to carry out genetic tests on individuals' tumours. [National Health Service, United Kingdom]

Agency Information Collection Activities: Proposed Collection; Comment Request [Department of Health and Human Services, United States]

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BUSINESS


University of Minnesota, Mayo Clinic Sign Research Pact with Karolinska
The University of Minnesota and Mayo Clinic, under the mantle of the Minnesota Partnership for Biotechnology and Medical Genomics, have formed a strategic research relationship with the Karolinska Institute of Stockholm, Sweden. Leaders of each institution signed memoranda of understanding to commit to the formal ongoing collaboration, called the Frontiers of Biomedical Research. [Mayo Clinic Press Release]

New Genomic Cancer Care Alliance Formed to Study Whole-Genome Sequencing in Cancer Treatment
Life Technologies Corporation announced the creation of the Genomic Cancer Care Alliance to help people battling cancer gain access to treatment options found through analysis of their genomic information. [Life Technologies Corporation Press Release]

Ascenta Therapeutics Licenses Cancer Drug Candidates to Sanofi-Aventis
Ascenta Therapeutics announced the signing of a global collaboration and licensing agreement with sanofi-aventis covering several early-stage agents being investigated for their potential to restore tumor cell apoptosis. [Ascenta Therapeutics Press Release]

Opal Therapeutics Inc. and Massachusetts General Hospital Enter Joint Development Collaboration and Initiate HIV Immunotherapy Clinical Studies
Opal Therapeutics Inc. and Massachusetts General Hospital have entered into a joint development collaboration agreement to develop a novel immunotherapy to treat HIV. [PR Newswire]

The New York Stem Cell Foundation Awards Fellowships to Eight Innovative Stem Cell Scientists
The New York Stem Cell Foundation (NYSCF) announced the award of eight new NYSCF-Druckenmiller Fellows. [The New York Stem Cell Foundation Press Release]

GnuBio, a Harvard Spinout, Aims to Become an “eBay of Biomarkers”
GnuBio is a new Harvard University spinout that is poised to become an “eBay of Biomarkers,” according to founder John Boyce. The company is part genome sequencing, part database management, part social network. [Harvard School of Engineering and Applied Sciences Press Release]




NIH


STAR METRICS: New Way to Measure the Impact of Federally Funded Research
A new initiative–Science and Technology for America’s Reinvestment: Measuring the Effect of Research on Innovation, Competitiveness and Science, or STAR METRICS–promises to monitor the impact of federal science investments on employment, knowledge generation, and health outcomes.

Clarification of Requirements for Clinical Trials Populations and Data Sharing Plans for RFA-HD-10-008, Maternal Fetal Medicine Units Network (U10) (NOT-HD-10-011)

Administrative Supplements to Increase Public Awareness of Pediatric Cancers and Available Treatments and Research (NOT-CA-10-026)

Heart Failure Clinical Research Network Regional Clinical Centers (U10) (RFA-HL-12-001)

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CBER


Market Withdrawal of GAMMAGARDLIQUID, Immune Globulin Intravenous (Human)
This voluntary market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots.

Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop (Update)




REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

FDA Announces Collaboration with Drugs.com
The U.S. Food and Drug Administration announced that it will collaborate with the Web site Drugs.com to expand access to the FDA’s consumer health information.

2010 Biological License Application Approvals

2010 Biological Device Application Approvals




EVENTS


Select Biosciences 3rd Annual Cancer Proteomics Conference
June 8-9, 2010
Berlin, Germany

Select Biosciences Inaugural Advances in Antibody and Peptide Therapeutics
June 8-9, 2010
Berlin, Germany

Regenerative Medicine in 21st Century: Managing Uncertainty at the Global Level Conference
June 9-10, 2010
Madison, United States

8th International Conference on Cell and Stem Cell Engineering
June 11-12, 2010
Dublin, Ireland

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – European Union 2010
June 13-17, 2010
Galway, Ireland

The First Cedars-Sinai Regenerative Medicine Scientific Symposium
June 14, 2010
Los Angeles, United States

International Society for Stem Cell Research (ISSCR) 8th Annual Meeting
June 16-19, 2010
San Francisco, United States

Accelerating Anticancer Agent Development and Validation
June 23-25, 2010
North Bethesda, United States

XXXIst International Congress of the International Society of Blood Transfusion (ISBT) in joint cooperation with the 43rd Congress of the German Society for Transfusion Medicine and Immunohematology (DGTI)
June 26-July 1, 2010
Berlin, Germany

Translational Cancer Medicine 2010 – USA
July 11-14, 2010
San Francisco, United States

United Kingdom National Stem Cell Network (UKNSCN) Annual Scientific Conference
July 12-14, 2010
Nottingham, United Kingdom

2nd International Conference on Cellular and Molecular Bioengineering (ICCMB2)
August 2-4, 2010
Singapore City, Singapore

CHI's 5th Annual Immunotherapeutics and Vaccine Summit (ImVacS)
August 17-19, 2010
Cambridge, United States

Select BioSciences 3rd Annual Stem Cells Europe Conference
August 24-25, 2010
Edinburgh, Scotland

Select Biosciences 2nd Annual World Biobanking Summit
August 24-25, 2010
Edinburgh, Scotland

Select Biosciences Inaugural Cellular Therapy Summit
August 24-25, 2010
Edinburgh, Scotland

International Society for Cellular Therapy (ISCT) – Europe 2nd Regional Meeting
September 11-14, 2010
Belgirate, Italy

Hydra VI: The European Summer School on Stem Cells & Regenerative Medicine
September 11-17, 2010
Hydra, Greece

Joint Metastasis Research Society – American Association of Cancer Research Conference on Metastasis and the Tumor Microenvironment
September 12-15, 2010
Philadelphia, United States

Stem Cells USA & Regenerative Medicine Congress 2010
September 13-15, 2010
Philadelphia, United States

Select Biosciences 7th Annual RNAi & miRNA Europe
September 14-15, 2010
Dublin, Ireland

Select Biosciences Inaugural Epigenetics Europe Conference
September 14-15, 2010
Dublin, Ireland

Select Biosciences Inaugural Genomics Automation Europe Conference
September 14-15, 2010
Dublin, Ireland

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Asia Pacific 2010
September 15-17, 2010
Sydney, Australia

4th American Association of Cancer Research International Conference on Molecular Diagnostics in Cancer Therapeutic Development
September 27-30, 2010
Denver, United States

Select Biosciences 6th Annual Ion Channel Targets Conference
September 28-29, 2010
Washington, DC, United States

2010 World Stem Cell Summit
October 4-6, 2010
Detroit, United States

5th World Congress on Preventive & Regenerative Medicine (WCRM)
October 5-7, 2010
Hannover, Germany

American Association of Blood Banks (AABB) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010
October 9-12, 2010
Baltimore, United States

Translational Cancer Research for Basic Scientists
October 17-22, 2010
Boston, United States

3rd Annual Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM)
October 26-27, 2010
Dubai, United Arab Emirates

World Stem Cells & Regenerative Medicine Congress Asia 2010
October 26-29, 2010
Singapore City, Singapore

Select Biosciences 3rd Annual Molecular Diagnostics World Congress
October 28-29, 2010
San Diego, United States

Fraunhofer Life Science Symposium 2010
October 29-30, 2010
Leipzig, Germany

Stem Cell Society Singapore Symposium 2010: Translating Science to Therapy
November 2-3, 2010
Singapore City, Singapore

Select Biosciences 5th Annual European Biomarkers Summit
November 9-10, 2010
Florence, Italy

Select Biosciences International Forum on Stem Cells
November 12-13, 2010
Tianjin, China

Select Biosciences 2nd Annual RNAi Asia Conference
November 15-16, 2010
Singapore City, Singapore

Stem Cell Network 10th Annual Scientific Meeting
November 22-24, 2010
Calgary, Canada

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – North America 2010 Annual Conference
December 5-8, 2010
Orlando, United States

Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.


 

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