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December News Roundup

Posted By Connections Editor, Tuesday, December 31, 2013
Updated: Monday, December 23, 2013

OMP-54F28 (Fzd8-Fc) Program Reaches Dose Escalation Milestone in Phase 1a Clinical Trial; Triggers $15 Million Payment From Bayer Pharma AG

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells, or tumor-initiating cells, announced today that it has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase 1a clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway.

$100 Million Gift Launches Sanford Stem Cell Clinical Center
In a bold and singular step toward delivering the therapeutic promise of human stem cells, businessman and philanthropist T. Denny Sanford has committed $100 million to the creation of the Sanford Stem Cell Clinical Center at the University of California, San Diego.The Sanford Center will accelerate development of drugs and cell therapies inspired by and derived from current human stem cell research; establishing, promoting and disseminating clinical trials and patient therapies that will help more quickly transform promise into reality.

ViGene Biosciences Introduces World's Largest Collection of Pre-Made Human Full-Length cDNA ORF and miRNA Adenoviruses
ViGene Biosciences, Inc. announced the launch of its world's largest collection of premade human full-length cDNA ORF and miRNA adenoviruses. The collection features over 1,240 pre-packaged human miRNA precursor adenoviruses and 6,000 pre-packaged human full-length cDNA adenoviruses.

Actinium Pharmaceuticals Announces Plans for Iomab™-B Phase III Pivotal Trial Following Meeting with FDA
Actinium Pharmaceuticals, Inc. a biopharmaceutical company developing targeted payload immunotherapeutics for the treatment of advanced cancers, provided a corporate update on its two most advanced clinical programs. Kaushik J. Dave Ph.D., MBA, President and Chief Executive Officer discussed recent progress and outline development plans for the company's clinical stage products: Iomab™-B and Actimab™-A.

Americord Advances Method of Obtaining Mesenchymal Stem Cells from the Placenta
Americord, announced that it has validated a revised process for the preservation of mesenchymal stem cells (MSCs) from placenta tissue. The new method greatly improves the success rate for preserving viable MSCs from Placenta Tissue, a service first developed in 2012.

Polaris Group Announces Treatment of First Patient in Phase II Study of ADI-PEG 20 in Acute Myeloid Leukemia
Polaris Group announced that the first patient has been dosed in its Phase II trial of ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of Relapsed/Refractory Acute Myeloid Leukemia.

The Leukemia & Lymphoma Society Applauds FDA's Approval of Gazyva® as First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration's (FDA's) approval of Gazyva® is an important advance for patients diagnosed with chronic lymphocytic leukemia (CLL). Gazyva, the first treatment approved through the FDA's breakthrough therapy designation, is indicated in combination with chlorambucil to treat previously untreated patients with CLL.

Kiadis Pharma Provides Positive Update on its Phase II Clinical Program with Blood Cancer Treatment ATIR™
Kiadis Pharma B.V. announced the successful Phase II enrollment of approximately ten patients of whom the majority have already been transplanted and received ATIR™.

New HHS Rule: Blood Stem Cells Aren't for Sale
The Department of Health and Human Services has issued a proposed rule that would include hematopoietic stem cells acquired by apheresis under the definition of "human organ," precluding payment for them.

ERYTECH Announces Positive DSMB Review of its Phase IIb Study in Acute Myeloid Leukemia
ERYTECH Pharma announced that an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the company’s Phase IIb study in Acute Myeloid Leukemia study and unanimously recommended continuation of the trial without modification

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