Volume 12.16 | Apr 25

Cell Therapy News 12.16, April 25, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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TOP STORY
Sandia and the University of New Mexico Lead Effort to Destroy Cancers
Melding nanotechnology and medical research, researchers have produced an effective strategy that uses nanoparticles to blast cancerous cells with a mélange of killer drugs. [Press release from Sandia National Laboratories discussing online prepublication in Nature Materials]

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SCIENCE NEWS

Researchers Inject Nanofiber Spheres Carrying Cells into Wounds to Grow Tissue
For the first time, scientists have made star-shaped, biodegradable polymers that can self-assemble into hollow, nanofiber spheres, and when the spheres are injected with cells into wounds, these spheres biodegrade, but the cells live on to form new tissue. [Press release from the University of Michigan discussing online prepublication in Nature Materials]

Decoding Cancer Patients’ Genomes Is Powerful Diagnostic Tool
Two new studies highlight the power of sequencing cancer patients’ genomes as a diagnostic tool, helping doctors decide the best course of treatment and researchers identify new cancer susceptibility mutations that can be passed from parent to child. [Press release from Washington University in St. Louis discussing online prepublication in the Journal of the American Medical Association]

Enhanced Cord Blood Stem Cell Transplants Safe in Long-Term Studies
An innovative experimental treatment for boosting the effectiveness of stem-cell transplants with umbilical cord blood has a favorable safety profile in long-term animal studies, report scientists. [Press release from ScienceDaily discussing online prepublication in Cell Stem Cell]

New Study Finds Better Strategy for Lymphoma Immunotherapy
An extra boost to extend the cancer-fighting power of specially engineered immune system cells proved effective in a preliminary study involving six lymphoma patients, said researchers. [Press release from Baylor College of Medicine discussing online prepublication in the Journal of Clinical Investigation]

Simple Injection Could Limit Damage from Heart Attacks and Stroke
Medical researchers held out promise that a simple injection is being developed to limit the devastating consequences of heart attacks and strokes. They identified an enzyme, mannan binding lectin-associated serine protease-2, that is found in blood and is a key component of the lectin pathway of complement activation, a component of the innate immune system. [Press release from the University of Leicester discussing online prepublication in the Proceedings of the National Academy of Science]

Scientists Identify a Surprising New Source of Cancer Stem Cells
Researchers have discovered that a differentiated cell type found in breast tissue can spontaneously convert to a stem-cell-like state, the first time such behavior has been observed in mammalian cells. [Press release from Whitehead Institute for Biomedical Research discussing online prepublication in the Proceedings of the Natural Academy of Science]

Potential New Blood Test and Treatment for Breast Cancer Announced by Sialix, Inc. and Researchers at the University of California, San Diego
Sialix, Inc. announced the results of a study it participated in that could have significant impact in the prediction, early detection and treatment of cancer in humans. [Press release from the Sialix, Inc. discussing online prepublication in Cancer Research]

A Cancer Marker and Treatment in One?
Researchers say antibodies to a non-human sugar molecule commonly found in people may be useful as a future biomarker for predicting cancer risk, for diagnosing cancer cases early and, in sufficient concentration, used as a treatment for suppressing tumor growth. [Press release from the University of California, San Diego discussing online prepublication in Cancer Research]

Louisiana State University Health Sciences Center Research Discovery May Block ALS Disease Process
In the first animal model of amyotrophic lateral sclerosis (ALS), researchers have found in fruit flies that blocking the abnormal movement of a protein made by a mutated gene called FUS also blocks the disease process. [Press release from EurekAlert! discussing online prepublication in Human Molecular Genetics]

Improved Recovery of Motor Function After Stroke
Scientists report a two-pronged molecular therapy that leads to significant recovery of skilled motor function in a rat model of stroke. [Press release from Children’s Hospital Boston discussing online prepublication in the Journal of Neuroscience]

University of Southern California, Massachusetts Institute of Technology Researchers Develop Gene Therapy with Potential to Restore Sight to the Blind
Researchers have developed a potential therapy for blindness that involves delivering a gene encoding a light-sensitive protein to inner retinal cells, enabling photosensitivity in these cells and restoring visual function in mouse models. [Press release from the Massachusetts Institute of Technology discussing online prepublication in Molecular Therapy]

Scientists Engineer Nanoscale Vaults to Encapsulate ‘Nanodisks’ for Drug Delivery
Scientists demonstrated the ability to package drug-loaded “nanodisks” into vault nanoparticles, naturally occurring nanoscale capsules that have been engineered for therapeutic drug delivery. [Press release from the University of California, Los Angeles discussing online prepublication in Small]

Cancer Breath Test ‘Step Closer’
Researchers found an “electronic nose” was able to identify chemical signals of cancer in the breath of patients with lung or head and neck cancer. [Press release from BBC discussing online prepublication in the British Journal of Cancer]

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CURRENT PUBLICATIONS
(Ranked by Impact Factor of the Journal)

The Targeted Delivery of Multicomponent Cargos to Cancer Cells by Nanoporous Particle-Supported Lipid Bilayers
Investigators report porous nanoparticle-supported lipid bilayers (protocells) that synergistically combine properties of liposomes and nanoporous particles. [Nat Mater]

Nanofibrous Hollow Microspheres Self-Assembled from Star-Shaped Polymers as Injectable Cell Carriers for Knee Repair
Scientists report nanofibrous hollow microspheres self-assembled from star-shaped biodegradable polymers as an injectable cell carrier. [Nat Mater]

Use of Whole-Genome Sequencing to Diagnose a Cryptic Fusion Oncogene
The objective of this study is to determine whether whole-genome sequencing can identify cryptic, actionable mutations in a clinically relevant time frame. [JAMA]

Identification of a Novel TP53 Cancer Susceptibility Mutation through Whole-Genome Sequencing of a Patient with Therapy-Related Acute Myeloid Leukemia
The objective of this study is to apply whole-genome sequencing to a patient without any significant family history of cancer but with suspected increased cancer susceptibility because of multiple primary tumors to identify rare or novel germline variants in cancer susceptibility genes. [JAMA]

Prostaglandin E2 Enhances Human Cord Blood Stem Cell Xenotransplants and Shows Long-Term Safety in Preclinical Nonhuman Primate Transplant Models
Researchers describe preclinical analyses of the therapeutic potential of dimethyl-prostaglandin E2 treatment by using human and nonhuman primate hematopoietic stem cells. [Cell Stem Cell]

CD28 Costimulation Improves Expansion and Persistence of Chimeric Antigen Receptor–Modified T Cells in Lymphoma Patients
Investigators designed a study that allowed them to directly measure the consequences of adding a costimulatory endodomain to chimeric antigen receptor-redirected T cells. [J Clin Invest]

Targeting of Mannan-Binding Lectin-Associated Serine Protease-2 (Masp2) Confers a Significant Degree of Protection from Myocardial and Gastrointestinal Ischemia/Reperfusion Injury
Researchers developed a unique model of total lectin pathway deficiency, a mouse strain lacking MASP-2, and analyzed the role of MASP-2 in two models of postischemic reperfusion injury. [Proc Natl Acad Sci U S A]

Normal and Neoplastic Nonstem Cells Can Spontaneously Convert to a Stem-Like State
Findings demonstrated that normal and cancer stem cell-like cells can arise de novo from more differentiated cell types and that hierarchical models of mammary stem cell biology should encompass bidirectional interconversions between stem and nonstem compartments. [Proc Natl Acad Sci U S A]

 
 
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POLICY

Family Cord Blood Banking Act Introduced in 112th Congress
Cord Blood Registry announced its support of legislation introduced by U.S. Representatives Wally Herger and Ron Kind, called “The Family Cord Blood Banking Act.” This important legislation would amend the IRS Code to allow individuals and couples to use flexible spending account, health savings account, health reimbursement arrangements or the medical expenses tax deduction to pay for umbilical cord blood banking services. [Congress, United States]
 
Senate Committee Approves Bill About Information on Umbilical Cord Blood
The Senate Health Committee approved a bill that would require the Missouri Health Department to share information about umbilical cord blood banking with pregnant women. [Missouri Senate Health Committee, United States]

Senate Subcommittee Proposes Higher Ed Budget
Lawmakers appear to disagree over exactly how to fund Michigan State University and Michigan’s 14 other public universities, with differing funding proposals emerging in the Legislature [Senate Subcommittee, United States]

Top Court Takes No Action on Obama Healthcare Case
The U.S. Supreme Court took no action on a request to speed up a ruling on President Barack Obama’s healthcare overhaul law, his signature domestic accomplishment that has provoked a fierce political battle. [U.S. Supreme Court, United States]

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BUSINESS

Horizon and Fox Chase Cancer Center Announce a New Centre of Excellence in Mammalian Gene Editing
Horizon Discovery has announced that it has entered into a three-year collaboration with the Fox Chase Cancer Center. [Horizon Discovery Press Release]

Genmab and Seattle Genetics Expand Antibody-Drug Conjugate Collaboration
Genmab A/S and Seattle Genetics, Inc. announced that the companies have entered into a second antibody-drug conjugate research collaboration agreement. [Seattle Genetics, Inc. Press Release]

Stanford and SanBio Announce a Clinical Trial of Cell Therapy for Stroke Disability
The Stanford University School of Medicine and SanBio Inc. announced the initiation of a Phase I/IIa clinical trial testing the safety and efficacy of a novel allogeneic cell therapy product, SB623, on patients suffering from stable deficits resulting from previous stroke injuries. [PR Newswire]

Precision NanoSystems and Alnylam Form New Delivery Collaboration
Precision NanoSystems, Inc. and Alnylam Pharmaceuticals, Inc. announced that the two companies have formed an exclusive collaboration focused on the discovery and development of novel lipid nanoparticles, known as small lipid nanoparticles, using microfluidics technology. [Alnylam Pharmaceuticals, Inc. Press Release]

bluebird bio Secures Additional $30 Million in Financing; ARCH Venture Partners Joins Investor Team
bluebird bio announced that the company has secured an additional $30 million in financing. [bluebirdbio™ Press Release]

Rice Wins $1.2 Million for Heart-Valve Tissue Research
A team of bioengineers from Rice University is bringing a promising new strategy for growing replacement heart valves closer to reality, thanks to a four-year, $1.2 million grant from the National Institutes of Health. [Rice University Press Release]

$20 Million Endowment for Biomedical Engineering Research
A $20 million endowment to foster research collaboration between bioengineers and clinicians, with the ultimate goal to develop new technologies to improve patient care, has been created by Duke University and the Wallace H. Coulter Foundation. [Duke University Press Release]

Circassia Completes £60 Million ($98 Million) Fundraising For Final-Stage Development of Lead Allergy Products
Circassia Ltd. announced that it has closed a £60 million ($98 million) fundraising. [Circassia Ltd. Press Release]

Biomedical Innovation Fund Awards $265,000 for U.Va. Projects
From a retraction device for gallbladder extraction during laparoscopic surgery to a medicine for treating cigarette-induced emphysema to a treatment for medication-resistant chronic pain, six innovative University of Virginia (U.Va.) biomedical research projects are the recipients of $265,000 in new support from the University’s Biomedical Innovation Fund. [University of Virginia Press Release]

FDA Approves Roche’s HPV Test for Identifying Women at Highest Risk for Cervical Cancer
Roche announced that the US Food and Drug Administration has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. [Hoffmann-La Roche Ltd. Press Release]

FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration. [Regeneron Pharmaceuticals, Inc. Press Release]

ACT Files European Clinical Trial Application for Phase I/II Study Using Embryonic Stem Cells to Treat Macular Degeneration
Advanced Cell Technology, Inc. (ACT) announced that it has filed a clinical trial application with the European Medicines and Healthcare products Regulatory Agency seeking clearance to initiate its Phase I/II clinical trial using retinal pigment epithelial cells derived from human embryonic stem cells to treat patients with Stargardt’s Macular Dystrophy. [PRNewswire]

Geron Announces the Appointment of Melanie Nallicheri as Senior Vice President of Corporate Development for Cell Therapies
Geron Corporation announced the appointment of Melanie I. Nallicheri as Senior Vice President, Corporate Development, Cell Therapies. [BusinessWire]

Carmell Therapeutics Completes Series A Financing to Advance the Development of Novel Bioactive Plastics
Carmell Therapeutics has closed on a Series A financing it will use to establish a pilot manufacturing facility and collect data for early clinical validation for the Company’s first products. [PRNewswire]

IUPUI Faculty Member to Receive National Innovative Vision Research Award
Jason S. Meyer, Ph.D. will be honored by the largest eye and vision research organization in the world for work which one day may lead to reversal of blindness caused by macular degeneration, retinitis pigmentosa and other diseases of the retina. [Indiana University-Purdue University Indianapolis (IUPUI) Press Release]

CESAR Participating in EuroTARGET, an EU-Funded Project in Renal Cell Carcinoma
The EuroTARGET consortium will create a standardized European clinical databank and bio-repository (DNA, serum and frozen tumour tissue) of a large series of patients with metastasized renal cell cancer treated with different agents. [Central European Society for Anticancer Drug Research (CESAR) Press Release]


NIH

Scientific Community Leaders Meet May 2 to Begin Advising NIH’s Center for Scientific Review
Scientific experts from across the country have joined a new council that will begin meeting May 2, 2011, to advise the Center for Scientific Review (CSR) at the National Institutes of Health on the peer review of NIH grant applications in scientific review groups at CSR.

Three NIH Scientists Elected to American Academy of Arts and Sciences
Three National Institutes of Health scientists have been elected to the American Academy of Arts and Sciences, whose members include some of the world’s most accomplished leaders from academia, business, public affairs, the humanities, and the arts.

Emphasis on Earlier Diagnosis in New Alzheimer’s Guidelines
For the first time in 27 years, researchers have released new criteria for diagnosing Alzheimer’s disease. With tests to pick up the earliest stages of the disease not yet ready for widespread use, the new guidelines will have little immediate impact on patients, but they are intended to provide a framework for research and to hopefully prepare clinicians for the day when effective treatments become available.

National Institutes of Health Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (FR Doc. 2011-9509)

National Institutes of Health: Government-Owned Inventions; Availability for Licensing [FR Doc.2011-9571]

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-9493)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-9495)

Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2011-9498)

Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2011-9577)

National Cancer Institute; Notice of Meeting (FR Doc. 2011-9710)

National Cancer Institute; Notice of Closed Meeting (FR Doc. 2011-9715)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2011-9573)

National Human Genome Research Institute; Notice of Closed Meeting FR Doc. 2011-9719)

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings (FR Doc. 2011-9572)

RFP Announcement: An Integrated Approach to Understanding Host-Pathogens Interactions (RFP: NIAID-DMID-NIHAI2010100)

Notice of Cancellation of Integrated Preclinical/Clinical AIDS Vaccine Development Program (NOT-AI-11-043)

Request for Information (RFI): Pediatric and Geriatric Animal Models and Medical Countermeasures Development for Mitigation and Treatment of Radiation Exposure from a Radiological or Nuclear Incident (NOT-AI-11-044)

Request for Information (RFI) Related to a Planned Funding Opportunity for Support of Basic and Translational Research in the Area of Tumor Glycomics (NOT-CA-11-012)

Modification of PAR-10-206: NCRR Science Education Partnership Award (SEPA) (R25) (NOT-RR-11-005)


CBER

June 29, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement

Tissue Reference Group 2010 Updates

2011 Biological License Application Supplement Noteworthy Approvals

2011 Biological License Application Approvals


REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

FDA ‘Strategic Priorities 2011 – 2015’ Now Available
The U.S. Food and Drug Administration released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015.

Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records [Docket No. FDA-2011-N-0231]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting [Docket No. FDA-2011-N-0002]

EUROPEAN MEDICINES AGENCY (European Union)


European Medicines Agency Holds First Stakeholder Forum on the Implementation of the New Pharmacovigilance Legislation
On 15 April 2011 the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation with a broad cross-section of participants including industry, patient and healthcare professional representatives and national medicines regulatory authorities.

EU Body Relaxes Curb on Avastin Breast Cancer Use
European regulators said on Friday they were relaxing curbs on the use of Roche’s Avastin to allow its use with Xeloda, another type of chemotherapy that is also made by Roche.


EVENTS

NEW The World Congress on Industrial Biotechnology and Bioprocessing
May 8-11, 2011
Toronto, Canada

NEW 4th Stem Cells Europe
July 20-21, 2011
Edinburgh, Scotland

NEW ImVacS: The Immunotherapeutics & Vaccine Summit
August 16-18, 2011
Cambridge, United States

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


JOB OPPORTUNITIES

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

Quality Assurance Manager – Program in Children’s Regenerative Medicine (The University of Texas Medical School at Houston)

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

Tenure Track, Assistant/Associate Professor (University of Missouri-Kansas City School of Medicine)

Postdoc – Laboratory of Molecular Tumor Genetics (Duke-NUS Graduate Medical School)

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)

Postdoctoral Fellow in Gene Expression/Cancer and Stem Cell Biology (University of Cincinnati College of Medicine)

Postdoctoral Positions in Immune Cell Activation (Institut de recherches cliniques de Montréal)

Postdoctoral Position in Developmental Neurobiology (Institut de recherches cliniques de Montréal)


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