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OXiGENE, Inc. Message Board

  • pharma_cliff pharma_cliff Jul 30, 2014 11:38 AM Flag

    SOUTH SAN FRANCISCO, Calif., Nov 12, 2013 - EMA

    OXiGENE's Chief Executive Officer: "During the third quarter, we focused on pursuing our lead development programs and ensuring that we have the resources and capabilities we need to advance our ongoing clinical and regulatory strategies, and made progress in our earlier-stage programs. We have continued to focus on identifying a registration pathway in the US for ZYBRESTAT in ovarian cancer and, at the same time, pursuing registration for ZYBRESTAT in the EU for anaplastic thyroid cancer (ATC), utilizing the exceptional circumstances pathway for obtaining a European marketing authorization (MAA).

    I believe Dai has been working on this with EMA for the past 2+ years.

    When approved, it opens the door to treating some 800 ATC patients/yr.

    800 X $50,000. = $40M annual ATC sales

    The real potential in this, it opens the opportunity to use Zybrestat off-label in ovarian cancer with Avastin

    in 300,000 plus relapsed patients in the EU .

    Bottom line: It's safe, no real downside and it's better treatment than chemo.. and in ATC they have +20% OS.

    I firmly believe that this is the catalyst.

    Jun 10, 2013
    "ATC affects 800 to 1,000 patients each year in the U.S. and a similar number in the European Union with a reported median survival around 3-4 months, with fewer than 10 percent of patients surviving one year," said Julie A. Sosa, M.D., Duke University School of Medicine, Durham NC, who was the Principal Clinical Investigator of the study. "This final publication of the FACT study data, suggests there might be clinically meaningful increases in both overall survival and one-year survival with ZYBRESTAT. It may represent a potential new therapeutic option for patients with ATC, who to this day have limited treatment options and generally dismal outcomes."

    The preliminary results of the FACT study were previously presented as an oral presentation at American Society of Clinical Oncology (ASCO) meeting and named "Best of ASCO" in 2011.

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