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  • OncoSec Medical Inc. (ONCS) Submits Device Master File to FDA for Medical System that Treats Solid Tumor Cancers 0 comments
    Oct 21, 2011 10:18 AM | about stocks: ONCS
    OncoSec Medical Inc., an advanced-stage biomedical company focused on commercializing therapeutic oncology products, today announced that they have submitted to the US Food and Drug administration (FDA) the Device Master File (NYSEMKT:DMF) for their patented Onco Medical System (OMS). The OncoSec Medical System has been shown to be safe and effective for the treatment of solid tumor cancer cells in numerous clinical trials.

    The regulatory filling of the DMF, which includes technical manufacturing, clinical and non-clinical information, allows the FDA to review the complete OncoSec Medical system when any investigational clinical study application references its use.

    “This DMF submission brings the OncoSec Medical System another step closer to becoming the treatment of choice for different types of solid tumor cancers,” said Punit Dhillon, President and Chief Executive Officer of OncoSec in a press release on Thursday. “In a very short period of time, OncoSec has moved aggressively with its clinical and regulatory strategy, with the DMF being one important piece of that strategy. Moving forward, we will continue to demonstrate the value of our treatment approaches as our clinical studies begin.”

    The Oncology Medical System applies brief electrical pulses to the cancer cells of various solid tumor types to create a temporary, reversible increase in the permeability of cells membranes. This process, known as electroporation, can allow chemotherapeutic or immunotherapeutic agents to perform their intended function of rapidly killing cancerous cells or stimulating the body’s immune system in order to enhance its cancer-killing capabilities. Electro-oncology therapies can avoid the effects of surgery while reducing or eliminating the toxic side effects of chemotherapy and radiation.

    OncoSec will soon begin three Phase II clinical trials using the OncoSec Medical System for the treatment of melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

    More information is available at oncosec.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net
     
    Stocks: ONCS
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