Oblato Announces Discussion Outcome with FDA for Development

Oblato Announces Discussion Outcome with FDA for Development of OKN-007 for Diffuse Intrinsic Pontine Glioma


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PRINCETON, N.J., Dec. 10, 2020 /PRNewswire/ --
Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007.
Through this FDA meeting, the Company obtained consent from the FDA on important matters, such as patient population, starting dose, approach for dose escalation, and criteria for evaluating disease response.  Importantly, there was in depth discussion on how to actively utilize existing historical patient data instead of requiring a comparative group in consideration of the nature of DIPG, a severe rare pediatric glioma and the need for all patients to receive anti-cancer treatment.  The FDA also gave detailed advice on pharmacokinetic assessment and standard of care radiation therapy during the clinical study.  The detailed response from the FDA indicates their support and expectations for Oblato which is developing a new drug for the treatment of DIPG.

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