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ONCOMed Partial Clinical hold lifted in 3 months

  1. interestingtome

    1,847 Posts.
    1
    Dated Septmeber 2014 - OncoMed Pharmaceuticals, Inc.’s (OMED - Snapshot Report) shares were up 5.7% with the FDA lifting the partial clinical hold on yet another candidate in its pipeline – ipafricept. The company said that the FDA has removed the partial clinical hold on three phase Ib studies on ipafricept (FZD8-Fc, OMP-54F28).

    OncoMed and partner Bayer (BAYRY - Analyst Report) are jointly evaluating ipafricept in combination with standard-of-care chemotherapy for ovarian cancer (with carboplatin and Taxol), pancreatic cancer (with Gemzar and Abraxane) and liver cancer (with Nexavar).

    We remind investors that in Jun 2014 the FDA had placed a partial clinical hold on the phase Ib studies of ipafricept following the company’s announcement that it is halting patient enrollment and dosing with ipafricept. OncoMed took this action on the basis of careful analysis of mild-to-moderate bone adverse events.

    The FDA removed the partial clinical hold from the phase Ib studies on ipafricept following its review of a data package on clinical safety and efficacy and revised study protocols submitted by OncoMed

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