Volume 12.00 | Jan 3

Cell Therapy News 12.00, January 3, 2011.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  


Protein Wields Phosphate Group to Inhibit Cancer Metastasis 
By sticking a chemical group to it at a specific site, a protein arrests an enzyme that may worsen and spread cancer. In addition to highlighting a novel anti-cancer pathway, researchers found that the same deactivation of the enzyme called EZH2 is necessary for the formation of bone-forming cells from the stem cells that make them and other tissues. [Press release from The University of Texas MD Anderson Cancer Center discussing online prepublication in Nature Cell Biology]



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Most Common Adult Brain Cancer Linked to Gene Deletion, Doctors Say
A study has identified an important gene deletion in up to one of every four cases of glioblastoma. This deletion contributes to tumor development, promotes resistance to therapy and considerably worsens a patient’s survival prospects. [Press release from the Stanford University School of Medicine discussing online prepublication in the New England Journal of Medicine]
Scientists Identify Possible Gene Target for Treating a Form of Lymphoma
Researchers have identified a mutation in a gene that could lead to targeted therapies for certain lymphoma patients whose cure rates are currently poor. [Press release from the National Institutes of Health discussing online prepublication in Nature]

Gene Switch Has Same Effect on Heart as Two Weeks of Exercise
Researchers have discovered that tweaking DNA can counteract heart injury and mimic the effects of two weeks of endurance training. [Press release from The Telegraph discussing online prepublication in Cell]

New Evidence of Stem Cells' Pivotal Role in Cancer Shown in Study
Leukemia patients whose cancers express higher levels of genes associated with cancer stem cells have a significantly poorer prognosis than patients with lower levels of the genes, say researchers. [Press release from the Stanford University School of Medicine discussing online prepublication in the Journal of the American Medical Association]

Researchers Discover Human Immune System Has Emergency Backup Plan
New research reveals that the immune system has an effective backup plan to protect the body from infection when the “master regulator” of the body’s innate immune system fails. [Press release from the University of California, San Diego discussing online prepublication in Nature Immunology]

Some Cancer Drugs May Block Cellular 'Cross Talk' but Not Kill Cancer Cells
A class of drugs thought to kill cancer cells may in fact block “cross talk” between the cancer cell and normal immune cells, resulting in reduced cancer growth and spread — a discovery that could significantly alter the way cancer drugs are evaluated in the future. [Press release from ScienceDaily discussing online prepublication in the Journal of Clinical Investigation]

Amorcyte Stem Cell Therapy Demonstrates Clinically Significant Reperfusion in Severe Heart Attack Patients
Results of a clinical trial evaluating Amorcyte, Inc.’s lead product candidate, AMR-001 for the treatment of damaged heart muscle following acute myocardial infarction were reported. Data demonstrated a significant relationship between cell dose and biologic effect. [Press release from Amorcyte, Inc. discussing online prepublication in the American Heart Journal]

Many Cancer Cells Found to Have an 'Eat Me' Signal in Study
Researchers have discovered that many cancer cells carry the seeds of their own destruction — a protein on the cell surface that signals circulating immune cells to engulf and digest them. [Press release from the Stanford University School of Medicine discussing online prepublication in Science Translational Medicine]

Biochemist Works to Revolutionize Ovarian Cancer Treatment
A researcher is studying microRNAs and pinpointing those that could unleash the body’s natural cancer-fighting agents. Additionally, she is developing a novel method to effectively deliver this treatment to the targeted cells by using an unusual carrier — nanoparticles of gold. [University of Houston Press Release]

Invention Could Improve Cancer Drug Delivery, Lessen Harmful Effects of Chemotherapy
Researchers may have found a way to deliver chemotherapeutic drugs to cancer tissues in controlled doses without harming healthy body cells. If successful, the invention of gold-coated liposomes could make chemotherapy more effective to destroy cancer cells and alleviate the harmful side effects that can result from the treatment. [University of Arizona Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

NFKBIA Deletion in Glioblastomas
Deletion of NFKBIA has an effect that is similar to the effect of EGFR amplification in the pathogenesis of glioblastoma and is associated with comparatively short survival. [N Engl J Med]
Oncogenically Active MYD88 Mutations in Human Lymphoma
The MYD88 signaling pathway is integral to the pathogenesis of activated B-cell-like diffuse large B-cell lymphoma, supporting the development of inhibitors of IRAK4 kinase and other components of this pathway for the treatment of tumors bearing oncogenic MYD88 mutations. [Nature]
Association of a Leukemic Stem Cell Gene Expression Signature with Clinical Outcomes in Acute Myeloid Leukemia
High expression of an leukemic stem cell gene signature is independently associated with adverse outcomes in patients with acute myeloid leukemia. [JAMA]
IL-1Beta-Driven Neutrophilia Preserves Antibacterial Defense in the Absence of the Kinase IKKBeta
Despite the likelihood of immune suppression, pharmacological blockade of IKKbeta-NF-kappaB has been considered as a therapeutic strategy. However, researchers found neutrophilia in mice with inducible deletion of IKKbeta. [Nat Immunol]
C/EBP(Beta) Controls Exercise-Induced Cardiac Growth and Protects Against Pathological Cardiac Remodeling
Data indicate that C/EBP(beta) represses cardiomyocyte growth and proliferation in the adult mammalian heart and that reduction in C/EBP(beta) is a central signal in physiologic hypertrophy and proliferation. [Cell]

CDK1-Dependent Phosphorylation of EZH2 Suppresses Methylation of H3K27 and Promotes Osteogenic Differentiation of Human Mesenchymal Stem Cells
Findings define a signaling link between cyclin-dependent kinase 1 (CDK1) and enhancer of zeste homologue 2 (EZH2) that may have an important role in diverse biological processes, including cancer-cell invasion and osteogenic differentiation of mesenchymal stem cells. [Nat Cell Biol]
Tumor Endothelin-1 Enhances Metastatic Colonization of the Lung in Mouse Xenograft Models of Bladder Cancer
Researchers have evaluated whether tumor endothelin-1 expression can serve as a biomarker for lung metastasis and whether it is required for metastatic disease. [J Clin Invest]

CD34+ Cell Infusion After ST Elevation Myocardial Infarction Is Associated with Improved Perfusion and Is Dose Dependent
The effects of CD34+ cell IRA infusion during the repair phase after STEMI are dose dependent and, at a threshold dose of 10 million CD34+ cells, associated with a significant improvement in perfusion that may limit deterioration in cardiac function (IRA infusion of CD34+ cells in patients with acute myocardial infarction [AMR-01] NCT00313339). [Am Heart J]

Human TGFAlpha-Derived Peptide TGFalphaL3 Fused with Superantigen for Immunotherapy of EGFR-Expressing Tumors
Data here showed that the third loop of transforming growth factor alpha (TGFalphaL3) is capable of targeting superantigen to tumors and exerting an inhibitory effect on tumor growth, which enables TGFalphaL3SEAD227A to be an attractive candidate for the immunotherapy of EGFR-expressing tumors. [BMC Biotechnol]

Calreticulin Is the Dominant Pro-Phagocytic Signal on Multiple Human Cancers and Is Counterbalanced by CD47
Findings identify calreticulin as the dominant pro-phagocytic signal on several human cancers, provide an explanation for the selective targeting of tumor cells by anti-CD47 antibody, and highlight the balance between pro- and anti-phagocytic signals in the immune evasion of cancer. [Sci Transl Med]



Funding for Science and Research
Funding plans for science and research 2011/12 to 2014/15 were published by the Government. [Department for Business Innovation and Skills, United Kingdom]

Submission for OMB Review; Comment Request; National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative (FR Doc. 2010-32659) [Department of Health and Human Services, United States]


Advanced Cell Technology and The Roslin Institute Announce Agreement for Storage and Distribution of Embryonic Stem Cells Using ACT’s Blastomere Technology
Advanced Cell Technology, Inc. (ACT) announced that it has entered into a Memorandum of Understanding with Roslin Cells LTD of Scotland, in which the two companies contemplate a definitive collaboration agreement in the near future. [Advanced Cell Technology, Inc. Press Release]

Clinical Data, Inc. Closes Sale of FAMILION® Testing and Pharmacogenomics Biomarker Development Business to Transgenomic, Inc.
Clinical Data, Inc. announced that the Company has closed the sale of its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for $15.5 million. [Clinical Data, Inc. Press Release]

Metamark and HistoRx Announce Licensing Agreement for AQUA® Technology
Metamark Genetics, Inc., a privately held oncology-focused molecular diagnostics company, and HistoRx, Inc., a diagnostics company developing tissue-based diagnostic solutions to advance individualized patient care, announced a multi-year licensing agreement. [Metamark Genetics, Inc. Press Release]

Mesoblast Completes Acquisition of Angioblast
Regenerative medicine company, Mesoblast Limited, announced that it had completed its acquisition of United States company Angioblast Systems Inc. with the issue of 90.8 million ordinary shares to former Angioblast security holders, increasing the total number of shares on offer to 253.8 million shares. [Mesoblast Limited Press Release]

Biogen Idec and Neurimmune Announce Agreement on Three Neurodegenerative Disease Programs
Biogen Idec and Neurimmune Holding AG announced that Biogen Idec has acquired a subsidiary of Neurimmune, which includes the world-wide rights to three pre-clinical immunotherapy programs. [Biogen Idec Press Release]
Genocea Biosciences Closes $35 Million Series B Financing
Genocea Biosciences Inc., a vaccine discovery and development company pioneering a new class of T cell-based vaccines, announced that it has closed a $35 million Series B round of venture financing. [Genocea Biosciences Inc. Press Release]

Bellicum Pharmaceuticals Announces $3 Million in Convertible Note Funding
Bellicum Pharmaceuticals, Inc. announced $3 million in Convertible Note funding. The new funds will be used to prepare for Phase II trials of BPX-101, the company’s DeCIDe™ vaccine for metastatic castrate resistant prostate cancer, and CaspaCIDe™, a cell therapy safety switch under initial development in the hematopoietic stem cell therapy setting. [Bellicum Pharmaceuticals, Inc. Press Release]

Advanced Cell Technology Secures $25 Million Funding Commitment
Advanced Cell Technology, Inc. announced that it has entered into a $25 million non-convertible stock purchase agreement with Socius CG II, Ltd., a subsidiary of Socius Capital Group. [Advanced Cell Technology, Inc. Press Release]

Advanced Cell Technology Receives FDA Clearance for Clinical Trials Using Embryonic Stem Cells to Treat Age-Related Macular Degeneration
Advanced Cell Technology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application to treat Dry Age-Related Macular Degeneration using retinal pigment epithelial cells derived from human embryonic stem cells. [Advanced Cell Technology, Inc. Press Release]

Juventas Therapeutics Initiating Phase II Clinical Trial of JVS-100 for Treatment of Critical Limb Ischemia
Juventas Therapeutics announced that the U.S. Food and Drug Administration authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia. [PR Newswire]

CEL-SCI Commences Phase III Clinical Trial in Head and Neck Cancer
CEL-SCI Corporation announced that it has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy. [CEL-SCI Corporation Press Release]

ReNeuron Gives Update on Progress of Stroke Stem Cell Clinical Trial
ReNeuron Group plc is pleased to announce that, following a positive independent safety review of progress of the first patient treated in the PISCES clinical trial of ReNeuron’s ReN001 stem cell therapy for stroke, the clinical trial will now progress to treatment of the remainder of the first patient cohort. [ReNeuron Group plc Press Release]

Cephalon Appoints J. Kevin Buchi as Chief Executive Officer and Member of Cephalon Board of Directors
Cephalon, Inc. announced that its Board of Directors has appointed J. Kevin Buchi as Chief Executive Officer and a member of the company's Board. [Cephalon, Inc. Press Release]


NCI Announces Plans to Reinvigorate Clinical Trials
The National Cancer Institute (NCI) has announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies. [National Cancer Institute, United States]

National Cancer Institute; Notice of Meeting (FR Doc. 2010-32750)

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting (FR Doc. 2010-32645)

National Center for Research Resources; Notice of Closed Meetings (FR Doc. 2010-32024)

National Center for Research Resources; Notice of Meetings (FR Doc. 2010-32020)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2010-32124)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-32110)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-32100)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-32797)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-32254)


FDA Actions
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened to discuss the findings of PCV and PCV DNA in rotavirus vaccines.

Guidance for Industry: “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120




Gardasil Approved to Prevent Anal Cancer
The U.S. Food and Drug Administration approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus types 6, 11, 16, and 18 in people ages 9 through 26 years.

Advisory Committees; Tentative Schedule of Meetings for 2011 [Docket No. FDA-2010-N-0001]

Good Laboratory Practice for Nonclinical Laboratory Studies [Docket No. FDA-2010-N-0548]


European Medicines Agency and European Centre for Disease Prevention and Control Agree to Enhance Co-Operation
The European Medicines Agency and the European Centre for Disease Prevention and Control (ECDC) have signed a working arrangement, which aims to enhance co-operation and mutual consultation between the two Agencies on areas of common interest.


Personalized Medicine — The Evolving Regulatory Landscape
Personalized Medicine — The Evolving Regulatory Landscape, a joint BIA/MHRA conference on Wednesday 2 March in central London, is the ideal place to hear the latest thinking from senior experts at UK and European regulatory agencies.


Call for Input: Review to Improve Transparency of the Therapeutic Goods Administration (TGA)
The purpose of this paper is to provide early information on the opportunity to contribute to the transparency Review of the TGA.


NEW Human Embryonic Stem Cells: Do Unfertilized Human Eggs Offer Another Way?
January 5, 2011
San Diego, United States

NEW Personalised Medicine – The Evolving Regulatory Landscape
March 2, 2011
London, United Kingdom

NEW Keystone: Autophagy 2011
March 27-April 1, 2011
Whistler, Canada

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


Lab Technologist – Cell Separation (STEMCELL Technologies)

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

Lab Technologist – Tissue Culture (STEMCELL Technologies)

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