January 27, 2016 10:34 AM | 1 min read |
Shares of
Fate Therapeutics Inc
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(NASDAQ: FATE), a clinical-stage biopharmaceutical company engaged in the development of programmed cellular therapeutics, were trading lower by 5 percent at $2.37.Fate Therapeutics' stock was trading higher by more than 16 percent in the pre-market trading session and opened for trading at $2.92. The stock quickly rose to an intra-morning high of $3.08 before selling off.Fate Therapeutics
announced after Tuesday's market close that the U.S. Food and Drug Administration has cleared the company's investigation new drug (IND) application for ProTmune.The IND is now active and Fate Therapeutics noted it plans to initiate a multi-center, randomized, controlled Phase 1/2 clinical study."We are pleased to clear this important milestone with the FDA, and expect to initiate the clinical investigation of ProTmune in mid-2016 for the prevention of life-threatening complications that often compromise the curative potential of HCT," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Programming donor immune cells ex vivo to enhance therapeutic function upon adoptive transfer is a highly-differentiated therapeutic paradigm, which is easily integrated into current clinical practice and avoids costly and time-consuming measures, such as genetic engineering, cell expansion and cell separation. We believe the use of ProTmune as the donor cell source for HCT can meaningfully improve patient outcomes, decrease hospital length of stay by mitigating use of in-hospital drug treatments, and substantially reduce the overall cost of care."
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