Argos Therapeutics has announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC). AGS-003 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is individualized to each patient’s unique tumor.

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BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.

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According to researchers at Britain’s Institute of Cancer Research (ICR), a combination of three genetic abnormalities has a dramatic impact on how long prostate cancer patients are likely to live. They added that prostate cancer patients should be tested for specific genetic factors before doctors decide how aggressively to treat their tumors.

Agennix Expands Talactoferrin Phase 3 FORTIS-M Registration Trial Globally Agennix AG announced that the next stage of the FORTIS-M trial has begun, with the first patient being dosed in Europe. FORTIS-M is a Phase 3 registration trial evaluating oral talactoferrin versus placebo in advanced non-small cell lung cancer (NSCLC) in patients whose disease has progressed following two or more prior therapies. The trial is expected to enroll approximately 720 patients.

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The National Comprehensive Cancer Network (NCCN), an alliance of 21 of the world’s leading cancer centers, is taking a leadership role in the oncology community by planning the NCCN REMS Oncology Summit to discuss issues and recommendations regarding the appropriate application of REMS in oncology. During the REMS Summit, NCCN will present its recommendations regarding the development and implementation of REMS based on the expertise of pharmacists.

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Intellikine, Inc. has initiated a Phase I clinical trial for its targeted anticancer drug INK128, a novel orally-available small molecule inhibitor of both the TORC1 and TORC2 complexes. The mTOR kinase represents a central node in human cancer biology and has become an important target for oncology drug development. Unlike other drugs targeting the pathway, INK128 directly inhibits the activity associated with both the TORC1 and TORC2 complexes of the mTOR kinase.

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Researchers of Herbert Irving Comprehensive Cancer Center and the Columbia Initiative in Systems Biology have discovered two genes that appear to work together as master switches to turn on hundreds of other genes that drive the most aggressive forms of brain cancer: they hope their findings will help develop new approaches to treat these incurable tumors. These are the findings of a study published in the advanced online issue of the journal Nature.

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Radient Pharmaceuticals Corporation (RPC) has announced that it has signed a 3-year marketing, sales and distribution agreement with GenWay Biotech Inc. Under the terms of the agreement, GenWay Biotech Inc. has non-exclusive rights to distribute RPC’s Onko-Sure(TM) in vitro diagnostic cancer (IVD) test in the European Union, Middle East (excluding Israel), United Kingdom and Russia; and is responsible for product sales and marketing in these markets.

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Radiation oncologists at Cancer Treatment Centers of America® are adopting single-dose intraoperative radiation therapy (IORT) for use in patients with early-stage breast cancer. IORT is performed in the surgical suite immediately after tumor removal. Once the surrounding healthy organs and tissues are shielded, IORT uses a mobile linear accelerator to deliver a full dose of radiation directly to the tumor site.

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Sirtex Medical Inc. has announced the development and implementation of the Centers of Excellence (COE) Program. The COE designation recognizes premier hospitals and medical centers in the United States that have made significant contributions to interventional oncology research and clinical practice, including the use of SIR-Spheres microspheres. Manufactured by Sirtex, SIR-Spheres microspheres are the only FDA-approved radioactive microsphere therapy for the treatment of colorectal liver metastases.