FDA Supports Oblato DIPG Treatment Trial

Oblato says that in discussions with FDA officials on the company’s plan for a Phase 1/2 clinical trial to start developing a new treatment for diffuse intrinsic pontine clioma (DIPG), a rare pediatric disease, using the company’s OKN-007, the agency gave consent for matters such as patient population, starting dose, approach for dose escalation, and criteria for evaluating disease response.

A company statement says there was in-depth discussion on how to actively use existing patient data instead of requiring a comparative group in consideration of the nature of DIPG and the need for all patients to receive anti-cancer treatment.

The agency also reportedly gave detailed advice on pharmacokinetic assessment and standard of care radiation therapy during the clinical study.

“The detailed response from FDA indicates their support and expectations for Oblato, which is developing a new drug for the treatment of DIPG,” the company says.