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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Researchers at Drexel University are developing a new portable, low-cost, radiation-free breast cancer detector that can be used in a doctor’s office as a first-line to detect breast cancer in younger women and in women over 40 with mammographically dense-tissue breasts. The detector is based on piezoelectric fingers (an elastic and shear modulus sensor) developed at Drexel. In evaluations on tumor specimens, it has positively identified a 3mm tumor previously missed by mammography, ultrasound and the physician’s palpation.

According to new scientific findings published in Cancer Research, a journal of the American Association for Cancer Research, immune responses has the ability to kill tumors before they can be directed toward normal body tissue. Lead researcher Richard G. Vile, Ph.D said, “There are extremely precise mechanistic methods augmenting the ability of the immune system to distinguish between normal tissues and tumors.” “Understanding the multiple checks and safeguards against autoimmunity should allow us to understand more closely how to generate antitumor immunity,” she added.

Bayer’s cancer pill Nexavar shows promise in treating breast tumors, the second-most common form of cancer. Nexavar, when combined with standard chemotherapy Xeloda, helped keep tumors in check for a longer time than that in a control group of patients receiving Xeloda only, according to Bayer. Nexavar is one of Bayer’s most promising drugs and is sold as a liver and kidney cancer treatment in more than 70 countries. Bayer is also pursuing the approval of the drug for use against lung tumors.

Researchers at the University of Oklahoma Health Sciences Center, while studying the mechanics of blood clots, have discovered a new enzyme that not only affects the blood, but seems to play a primary role in how cancer tumors expand and spread throughout the body. A research group at OU led by Patrick McKee first discovered the enzyme called sFAP in plasma. After studying the biochemical makeup of the protein and identifying the gene that controlled its function, they began to search gene sequencing databases worldwide to find what it was.

The U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application for Akorn-Strides‘ Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. The joint venture between Akorn and Strides was formed to develop liquid, dry powder and lyophilized formulations of generic injectable pharmaceuticals for a wide market with focus on painkillers, anti-infectives and CNS medications. Pamidronate Disodium Injection has received the indication for use in the treatment of hypercalcemia related to tumors and Paget’s disease.

The U.S. Food and Drug Administration has given clearance to Ikonisys’ oncoFISH HER2 test, a fully computerized microscopy application to determine HER2 status in human specimens of breast cancer developed with Abbott’s PathVysion® HER2 DNA Probe Kit. The company’s proprietary CellOptics® platform which features the Ikoniscope® drives the test by providing an earlier and precise indication for amplification of gene. This diagnosis reveals whether a patient is a candidate for Herceptin (trastuzumab) treatment. Higher quantity of HER2 protein can lead to rapid growth of tumor, resistance to some types of treatment, prolonged illness and reduced survival period.

The U.S. Food and Drug Administration approved PharmaMar’s proposal for the process of production of Aplidin®. A novel anti-tumor agent derived from the sea, Aplidin® (Plitidepsin) is in its clinical stage of development and will be used for the treatment of hematological tumors. The starting materials needed to initiate the production process have also got the approval. FDA requires the companies producing drugs to submit all the paperwork regarding the method of production of their products.

The U.S. Food and Drug Administration has granted the Orphan Drug Designation to a unique drug for children suffering from Ewing’s Sarcoma cancer developed by the Cure Our Children Foundation. The non profit and charitable organization was successful in development of this drug because of the generous volunteers, doctors in industry and researchers at two universities. The approval facilitates the development of the drug by providing fee waivers, FDA’s assistance for review and other benefits. The new drug is a combination of biotechnology and nanotechnology. Cell matter is modified to have the genetic code of tumor cells. When the cancer cells uptake this matter, they stop reproducing and die.

Safety labeling revision for GlaxoSmithKline’s Tykerb (lapatinib tablets) that includes a boxed warning about the risk of hepatotoxicity has been approved by the U.S. Food and Drug Administration. Hepatotoxicity cases have been reported during clinical trials, some of them being severe. The FDA has noted that the onset of the disease has taken place within a few months from initiation of the therapy. Tests for liver functioning should be taken before starting and during lapatinib treatment, every month. Lapatinib is a kinase inhibitor to be used along with capecitabine in the treatment of advanced breast cancer in patients who did not benefit from a therapy earlier.