Cell Therapy News Volume 12.21 | May 30 2011

Human Brain’s Most Ubiquitous Cell Cultivated in Lab Dish
A group reports it was able to direct embryonic and induced human stem cells to become astrocytes in the lab dish. [Press release from the University of Wisconsin-Madison discussing online prepublication in Nature Biotechnology]

Pivotal Phase III Study Finds Overall Survival of Patients with Metastatic Castration-Resistant Prostate Cancer Is Significantly Improved with ZYTIGA™ (Abiraterone Acetate)
A study found that patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel showed a significant improvement in overall survival when treated with ZYTIGA™ (abiraterone acetate) plus prednisone compared to patients treated with prednisone plus placebo. [Press release from Centocor Ortho Biotech Inc. discussing online prepublication in the New England Journal of Medicine]

Scientists Turn Human Skin Cells Directly into Neurons, Skipping iPS Stage
Human skin cells can be converted directly into functional neurons in a period of four to five weeks with the addition of just four proteins, according to a study. [Press release from Stanford University School of Medicine discussing online prepublication in Nature]

Team Publishes Paper that Could Improve Gene Therapy
Many diseases are the result of defective genes, and gene therapy is the tantalizing prospect of inserting properly functioning genes into a sick patient. But many promising gene therapies falter after a few weeks, and lasting cures remain elusive. A new paper may give fundamental insights into how to prevent these genes from being turned off and could lead to new therapies that last much longer. [Press release from Brigham Young University discussing online prepublication in Nature]

Predicting the Fate of Personalized Cells Next Step Towards New Therapies, Study Suggests
Researchers looked at progenitors and found a way to potentially predict their fate. They base this on how histones are marked by other proteins. [Press release from the University of Pennsylvania Perelman School of Medicine discussing online prepublication in Science]

Scientists Find New Drug Target in Breast Cancer
Researchers have identified a new protein involved in the development of drug resistance in breast cancer which could be a target for new treatments. [Press release from Imperial College London discussing online prepublication in Nature Medicine]

Researchers Move Step Closer to Using iPS Cells in Regenerative Medicine
A group of researchers has succeeded in producing a new type of induced pluripotent stem (iPS) cells that is less carcinogenic, marking a step closer toward the use of iPS cells in regenerative medicine. [Press release from The Mainichi Daily News discussing online prepublication in Cell Stem Cell]

Scientists Discover Switch to Speed Up Stem Cell Production to Facilitate Development of Treatments for Diseases
A team of scientists has shown how proteins involved in controlling genes work together to carry out their functions in stem cells and demonstrated for the very first time, how they can change interaction partners to make other types of cells. [Press release from the Genome Institute of Singapore of the Agency for Science, Technology and Research discussing online prepublication in Stem Cells]

Nanoengineers Invent New Biomaterial that More Closely Mimics Human Tissue
A new biomaterial designed for repairing damaged human tissue doesn’t wrinkle up when it is stretched. The invention marks a significant breakthrough in tissue engineering because it more closely mimics the properties of native human tissue. [Press release from the University of California, San Diego Jacobs School of Engineering discussing online prepublication in Advanced Functional Materials]

Researchers Discover Key Molecule for Stem Cell Pluripotency
Researchers have discovered what enables embryonic stem cells to differentiate into diverse cell types and thus to be pluripotent. [Press release from Max Delbrück Center for Molecular Medicine Berlin-Buch discussing online prepublication in EMBO Reports]

Engineered Antibodies Cross Blood–Brain Barrier
By defying the classical rules of antibody engineering, researchers have constructed an antibody that is readily shuttled into the brain. The results suggest that the approach could be used to generate antibody-based therapies for brain diseases. [Press release from NatureNews discussing online prepublication in Science Translational Medicine]

Scientists Discover New Drug Target for Squamous Cell Carcinoma
Scientists have found that a protein called α-catenin acts as a tumor suppressor and they have also unlocked the mechanism by which this protein controls cell proliferation. [Press release from Fred Hutchinson Cancer Research Center discussing online prepublication in Science Signaling]

Athersys Announces Positive Interim Results from Ongoing Phase I Study of MultiStem® for Hematopoietic Stem Cell Transplant Support and Graft-Versus-Host Disease
Athersys, Inc. announced positive interim results from an ongoing Phase I clinical trial of MultiStem® administered to individuals undergoing allogeneic hematopoietic stem cell transplants for the treatment of leukemia and related conditions. [Athersys, Inc. Press Release]

Researcher Developing Blood Substitute
Vibhudutta Awasthi is developing a nano-sized carrier of hemoglobin that may be safer than other attempted blood substitutes. [The University of Oklahoma Health Sciences Center Press Release]

Researchers Discover Key to Making Cancer-Killing Peptides
Researchers have found the mechanism of action for cancer-cell-killing peptides. This breakthrough is expected to lead to better medication, in particular better treatments for leukemia, skin cancer, and infections caused by multi-resistant bacteria. [Aalto University Press Release]

Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Reduction in Clinical Events in Patients for 18 Months Compared with Placebo
Celladon Corp. announced that 18-month data from its Phase II CUPID clinical trial of MYDICAR® demonstrated continued improvements in clinical outcomes in advanced heart failure patients treated with the genetically-targeted enzyme replacement therapy. [Celladon Corporation Press Release]

Oxford BioMedica Announces Presentation of New Clinical Data from ProSavin Phase I/II Study in Parkinson’s Disease
Oxford BioMedica plc announced that new data from the on-going Phase I/II trial of ProSavin® for the treatment of Parkinson’s disease was presented. [Press release from Oxford BioMedica plc discussing research presented at the 14th Annual Meeting of the American Society of Gene and Cell Therapy]

Juventas Therapeutics Demonstrates JVS-100 Delivery to Patients with Heart Failure Is Safe and Provides Clinical Benefit
Juventas recently presented the results from its Phase I heart failure trial. [Press release from PR Newswire discussing research presented at the 14th Annual Meeting of the American Society of Gene and Cell Therapy]

Gene-Modified Stem Cells Help Protect Bone Marrow from Toxic Side Effects of Chemotherapy for Brain Cancer
Researchers reported that one possible approach to reduce chemotherapy’s toxic effect on bone marrow cells is to modify the cells with a gene that makes them resistant to chemotherapy. [Press release from Fred Hutchinson Cancer Research Center discussing research presented at the 14th Annual Meeting of the American Society of Gene and Cell Therapy]

Amsterdam Molecular Therapeutics Research Demonstrates AAV Delivery May Be Key Success Factor for Therapeutic Promise of RNAi
Amsterdam Molecular Therapeutics announced the results from studies exploring the role of adeno-associated viral (AAV) vectors for the efficient delivery of short and micro RNA to inhibit disease by RNA interference. [Press release from Amsterdam Molecular Therapeutics discussing research presented at the 14th Annual Meeting of the American Society of Gene and Cell Therapy]

Sangamo BioSciences and Collaborators Present Data Showcasing Broad Applications of ZFP Therapeutics®
Sangamo BioSciences, Inc. announced that data from clinical, preclinical and research-stage programs focused on the development of Zinc Finger DNA-Binding Protein (ZFP) Therapeutics® were described in twenty presentations given by Sangamo scientists and collaborators. [Press release from Sangamo BioSciences, Inc. discussing research presented at the 14th Annual Meeting of the American Society of Gene and Cell Therapy]

Neurologix Presents One-Year Follow-Up Data From Phase II Study of NLX-P101 in Parkinson’s Disease
Neurologix, Inc. announced the presentation of efficacy results through one year of follow-up in patients treated as part of the Company’s successful Phase II clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson’s disease. [Press release from Neurologix, Inc. discussing research presented at the International Neuromodulation Society’s 10th World Congress]

Abiraterone and Increased Survival in Metastatic Prostate Cancer
Scientists evaluated whether abiraterone acetate prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy. [N Engl J Med]

Induction of Human Neuronal Cells by Defined Transcription Factors
Researchers show that three transcription factors (Brn2, Ascl1 and Myt1l) can generate functional neurons from human pluripotent stem cells as early as 6 days after transgene activation. [Nature]

Determinants of Nucleosome Organization in Primary Human Cells
To identify major determinants of nucleosome organization in the human genome, investigators used deep sequencing to map nucleosome positions in three primary human cell types and in vitro. [Nature]

Chromatin “Prepattern” and Histone Modifiers in a Fate Choice for Liver and Pancreas
Investigators isolated mouse embryonic endoderm cells and assessed histone modifications at regulatory elements of silent genes that are activated upon liver or pancreas fate choices. [Science]

Specification of Transplantable Astroglial Subtypes from Human Pluripotent Stem Cells
In this study, human pluripotent stem cells were directed to nearly uniform populations of immature astrocytes (>90% S100β⁺ and GFAP⁺) in large quantities. [Nat Biotechnol]

Kinome Screening for Regulators of the Estrogen Receptor Identifies Lemur Tyrosine Kinase-3 as a New Therapeutic Target in Breast Cancer
An siRNA screen identified kinases whose silencing alters the estrogen response including those previously implicated in regulating estrogen receptor α activity (such as mitogen-activated protein kinase and AKT). [Nat Med]

Conversion of Sox17 into a Pluripotency Reprogramming Factor by Reengineering Its Association with Oct4 on DNA
Investigators show that Sox2 and Sox17 exhibit inverse heterodimerization preferences with Oct4 on the canonical versus a newly identified compressed sox/oct motif. [Stem Cells]

NSF Hopes Time Could Mean Money for Some Biologists
Data from the National Science Foundation (NSF) show that a handful of scientists seeking a research grant from its molecular and cellular biosciences division submit two proposals in the same funding cycle. [National Science Foundation, United States]

Senator’s Criticism of Science Foundation Draws Fire
Senator Tom Cobur’s latest salvo is a 73-page report that accuses the National Science Foundation of mishandling nearly $3 billion. But the report is itself filled with errors and questionable analyses, said science lobbyists. [Consortium of Social Science Associations, United States]

Two Candidates Nominated to Lead California Stem Cell Agency
Southern California investor Jonathan Thomas and cardiologist turned entrepreneur Frank Litvack have been nominated to lead the California Institute of Regenerative Medicine. [California Institute of Regenerative Medicine, United States]

U.S. Court Raises Standard for Bringing Down Patents
A U.S. appeals court that specializes in patent disputes made it harder for patents to be declared invalid because of gaps or errors in patent applications. [U.S. Appeals Court, United States]

Revamp for WHO
The top decision-making body at the World Health Organization (WHO) — the World Health Assembly — backed reforms that might bring the biggest changes to the agency in its 63-year history. [World Health Organization, Switzerland]

New Name for U.K. Biolab As Report Revives Site Debate
Officials at the UK Centre for Medical Research and Innovation announced that in July the facility will officially become the Francis Crick Institute to honor the British Nobel laureate who co-discovered the structure of DNA. [UK Centre for Medical Research and Innovation, United Kingdom]

Russia Revitalizes Science
Researchers drawn by ‘mega-grants’ find rewards and frustrations in equal measure. The 12-billion-rouble (US$428-million) ‘mega-grant’ program is part of Russia’s attempt to strengthen research at its neglected universities and modernize the country’s science and economy at large. Alas, Kafkaesque bureaucracy and a thicket of often-opaque regulations have survived the changes. [Russian Government, Russia]

France Set to Uphold Curbs on Embryonic Stem Cells
The National Assembly voted to uphold the curbs in the second reading of the new bioethics law. [National Assembly, France]

STEMSOFT® Software Inc. Launches Certified Partner Program
STEMSOFT Software Inc. announced the launch of a new Certified Partner Program. This new program is designed to help STEMSOFT clients identify complementary products or services that will be of benefit to them and ultimately assist them with finding the answers to the questions or unique need they have. [STEMSOFT Software Inc. Press Release]

Innovative Therapy Method for the Treatment of Brain Tumors
The Fraunhofer Institute for Cell Therapy and Immunology IZI and Northwest Biotherapeutics Inc. are cooperating in the development of production processes and establishment of an innovative therapy method for the treatment of glioblastomas in Europe. [Fraunhofer Institute for Cell Therapy and Immunology IZI Press Release]

Monash Leads Australia-India Research Collaboration
Monash projects have been awarded almost a quarter of the $5 million in available funding through Round 5 of the Australia-India Strategic Research Fund. [Monash University Press Release]

Coulter Foundation and Stanford Establish $20 Million Endowment for Bioengineering Projects to Fill Medical Needs
A $20 million endowment to support the translation of ideas that address unmet medical needs into treatments and devices that improve human health has been established in the Stanford University Department of Bioengineering, with support from the Wallace H. Coulter Foundation and the university. [Stanford University School of Medicine Press Release]

Kerecis Completes Interim Financing
Kerecis Limited has secured US$ 1 million in interim financing. The US$ 1 million financing is a mixture of equity, grants and debt and is provided by a group of existing and new stakeholders. [Kerecis Limited Press Release]

Prima BioMed Completes $21 Million Placement
Prima BioMed Ltd. announced that it has successfully completed the placement of new ordinary shares that was announced on Wednesday 25 May 2011. [Prima BioMed Ltd. Press Release]

Maryland Stem Cell Research Commission Funds 36 New Projects in FY 2011
The Maryland Stem Cell Research Commission has completed its review of the 180 applications received in response to its three FY 2011 Requests for Applications. [Maryland Stem Cell Research Fund Press Release]

Nationwide Children’s Hospital Researchers Receives NIH Grant for the Move Toward Clinical Trials Targeting the Lysosomal Storage Disease MPSIIIB
Investigators at Nationwide Children’s have received a grant from the National Institutes of Health (NIH) to help move a therapy for MPS IIIB that has been shown effective in mice toward clinical trials in humans. [Nationwide Children’s Hospital Press Release]

Four B.C. Cancer Researchers Receive Nearly $2 Million in Grants
Dr. Raymond Andersen is among four B.C. researchers to receive nearly $2 million from the Canadian Cancer Society. [Vancouver Sun]

UK’s NICE Backs Roche Drug as Maintenance Therapy
Roche’s cancer drug MabThera has been recommended for use on Britain’s state health service as a maintenance therapy for patients with follicular non-Hodgkin’s lymphoma, expanding the market for the medicine. [Reuters]

OncoSec Medical to Initiate Multiple Phase II Skin Cancer Clinical Trials
OncoSec Medical Incorporated announced it will initiate three Phase II clinical trials to assess its cancer-destroying, tissue-sparing ElectroImmunotherapy technology in patients with melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. [PR Newswire]

Adaptimmune Announces Opening of Phase I/II Clinical Trial in Multiple Myeloma
Adaptimmune announced that it has opened a Phase I/II, dual site, two‐cohort, open‐label clinical trial in multiple myeloma at the University of Maryland and the University of Pennsylvania testing its enhanced T cell receptor T cell therapy. [Adaptimmune Ltd. Press Release]

TxCell Receives Approval for Extension of Phase I/II Clinical Trial in Crohn’s Disease
TxCell SA announces the approval by AFSSAPS, the French regulatory agency, of its application to extend treatment of patients included in the Crohn’s Disease Phase I/II study with Ovasave, a type 1 regulatory T cell based immunotherapy. [TxCell SA Press Release]

Notification of Date of Preliminary Results and Update on Stroke Clinical Trial
ReNeuron Group plc announced the completion of dosing of the first cohort of patients in the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. [ReNeuron Group plc Press Release]

Patrick Hwu, M.D., and Mario Sznol, M.D., Join Genesis Biopharma’s Scientific and Medical Advisory Board
Genesis Biopharma, Inc. announced that Patrick Hwu, M.D., and Mario Sznol, M.D., have joined the Company’s recently formed Scientific and Medical Advisory Board. [Genesis Biopharma, Inc. Press Release]

Christopher Kane, M.D., Appointed C. Lowell & JoEllen Parsons Endowed Chair
Christopher Kane, M.D., has been named the inaugural holder of the C. Lowell and JoEllen Parsons Endowed Chair in Urology. [University of California, San Diego Press Release]

David Nassif Joins Histogen as President and CFO
Histogen, Inc. announced that David Nassif, J.D. has joined the Company as President and Chief Financial Officer. [Histogen, Inc. Press Release]

UCSF School of Medicine Names Vice Dean of Education
Catherine Reinis Lucey, M.D., has been appointed vice dean for education in the University of California, San Francisco (UCSF) School of Medicine. [University of California, San Francisco Press Release]

Flotte Elected to ASGCT Advisory Council
Terence R. Flotte, M.D. has been elected to a five-year term on the Advisory Council of the American Society of Gene & Cell Therapy (ASGCT). [University of Massachusetts Medical School Press Release]

Nobel Laureate Receives Porter Prize from Pitt’s Graduate School of Public Health
Françoise Barré-Sinoussi, Ph.D. is the 2011 recipient of the University of Pittsburgh Graduate School of Public Health’s Porter Prize in recognition of her outstanding achievements promoting health and preventing disease through her many contributions to HIV/AIDS research. [University of Pittsburgh Medical Center Press Release]

Alvarez-Buylla Recognized for Pioneering Stem Cell Research
Neural stem cell scientist Arturo Alvarez-Buylla, Ph.D. received word that he was one of three scientists named to receive the 2011 Prince of Asturias Award for Technical and Scientific Research. [University of California, San Francisco Press Release]

ISSCR Awards Announced for Innovation, Public Service and Outstanding Young Investigator
Three key awards – the International Society for Stem Cell Research (ISSCR) McEwen Centre Award for Innovation, the ISSCR Public Service Award and the Outstanding Young Investigator Award – will be presented at the 9th Annual Meeting of the International Society for Stem Cell Research. [International Society for Stem Cell Research Press Release]

Lee W. Wattenberg, M.D., Receives the 2011 AACR Award for Lifetime Achievement in Cancer Prevention Research
Lee W. Wattenberg, M.D., will receive the 2011 American Association for Cancer Research (AACR) Award for Lifetime Achievement in Cancer Prevention Research for his role in launching the field of chemoprevention and his work to understand the potential mechanisms of action of chemopreventive compounds. [American Association for Cancer Research Press Release]

Salk Gift Dedicates Two Endowed Chairs – in Honor of Nobel Prize Winners and Past Presidents
The Salk Institute for Biological Studies announced the visionary gift of Irwin and Joan Jacobs in the dedication of two endowed chairs to pay permanent tribute to Drs. Dulbecco and Guillemin. [Salk Institute for Biological Studies Press Release]

NIH and Non-Profits Sign Research and Development Agreement
The National Institutes of Health announced an agreement with two non-profit organizations to accelerate the development of potential clinical therapies for rare blood cancers.

Panel Wants NIGMS to Stop Funding Glue Grants
An expert panel has urged the National Institute of General Medical Sciences (NIGMS) to scrap an 11-year, $368 million foray into big biology.

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-12636)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-12940)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-12952)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-13108)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-13110)

Center for Scientific Review; Amended Notice of Meeting (FR Doc No: 2011-12729)

Center for Scientific Review; Amended Notice of Meeting (FR Doc No: 2011-12737)

Center for Scientific Review; Amended Notice of Meeting (FR Doc No: 2011-13079)

Clarification of NIH Fiscal Policy for Grant Awards – FY 2011 (NOT-OD-11-077)

Correction of RFA-MD-11-002: NIMHD Exploratory Centers of Excellence (P20) (NOT-MD-11-007)

National Cancer Institute; Notice of Closed Meetings (FR Doc No: 2011-12637)

National Cancer Institute; Amended Notice of Meeting (FR Doc No: 2011-12638)

National Human Genome Research Institute; Notice of Closed Meetings (FR Doc No: 2011-12634)

Office of the Director Amended Notice of Meeting (FR Doc No: 2011-13353)

CBER on Twitter

Roster of the Vaccines and Related Biological Products Advisory Committee

FOOD AND DRUG ADMINISTRATION (United States)

Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability [Docket No. FDA-2011-D-0305]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications, as Used by the Food and Drug Administration [Docket No. FDA-2011-N-0067]

Agency Information Collection Activities: Proposed Collection; Reports and Records Under Prescription Drug Marketing Act of 1987 [FR Doc No: 2011-13442]

Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals [Docket No. FDA-2011-N-0375]

Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Correction [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)]

EUROPEAN MEDICINES AGENCY (European Union)

ENCePP Publishes the ‘Guide on Methodological Standards in Pharmacoepidemiology’
The European Medicines Agency and the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology.

European Medicines Agency and Heads of Medicines Agencies Propose Measures to Make Information in Application Dossiers More Transparent
The European Medicines Agency and the Heads of Medicines Agencies have released a guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorization dossier for public consultation.

European Medicines Agency Marks 40th Anniversary of PIC/S
The European Medicines Agency is marking the 40th anniversary of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Study Provides Recommendations on European Medicines Agency’s Communication on Medicines
A report written by an independent expert has highlighted a number of recommendations to help improve the European Medicines Agency’s communication on the benefits and risks of medicines.

MEDICINES AND HEALTHCARE REGULATORY AGENCY (United Kingdom)

Information Sent to Healthcare Professionals in May About the Safety of Medicines
Copies of letters sent to healthcare professionals in May 2011, to inform of new safety information and advice.

Drug Safety Update: June 2011 (Volume 4, Issue 11)
Drug Safety Update is essential reading for all healthcare professionals, bringing the very latest information and advice to support the safer use of medicines.

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
Added amendment to Appendix 8

Australian Public Assessment Reports for Prescription Medicines (AusPARs)
Added Dabigatran etexilate mesilate, Rupatadine, Ferinject & Rosuvastatin

Presentations about Manufacturing Therapeutic Goods
Added presentations about quality risk management and clinical trials

Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
New therapeutic goods (excluded goods) order

Scheduling News
Updates and news about scheduling medicines and poisons

Scheduling FAQs
Updated FAQs on revised scheduling arrangements from 1 July 2010 and general scheduling matters

Advisory Committees on Medicines & Chemicals Scheduling (ACMS & ACCS)
Updated ACCS and ACMS meeting dates

NEW JAX® Type 2 Diabetes Complications Webinar
June 2, 2011
Webinar

NEW World Orphan Drug Congress Asia 2011
September 14-16, 2011
Seoul, Korea

NEW World Stem Cells & Regenerative Medicine Congress Asia 2011
October 11-13, 2011
Singapore, Singapore

NEW CTRC-AACR San Antonio Breast Cancer Symposium
December 6-10, 2011
San Antonio, United States

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

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