On July 30, 2019 Bexion Pharmaceuticals, Inc. an oncology-focused company reported the completion of a Type B End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) to discuss the End of Phase 1 and the design of a Phase 2 clinical trial for BXQ-350, the Company’s lead candidate, for the treatment of recurrent Glioblastoma Multiforme (rGBM) (Press release, Bexion, JUL 30, 2019, View Source [SID1234537917]).

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In the Type B meeting, the FDA provided guidance on various design aspects of Bexion’s proposed Phase 2 clinical trial. The trial is expected to enroll 55-60 patients.

"An End of Phase 1 meeting with the FDA is a significant regulatory milestone for any new clinical development program," said Dr. Richard Schwen, Regulatory Consultant for Bexion. "Such meetings are granted by the FDA only when significant data on the drug are available. Bexion’s recent meeting signals the FDA’s interest in the BXQ-350 program, and an opportunity for Bexion to obtain input to refine the remaining studies required for an FDA approval."

The Phase 2 trial is designed with learnings from the Phase 1 program, which dosed 93 patients, with 21 having rGBM. The Phase 1 program reached the highest planned dose and demonstrated a strong safety profile for BXQ-350.

Based upon the FDA’s feedback, Bexion will submit a Phase 2 clinical trial protocol and statistical analysis plan along with the requested Chemistry, Manufacturing and Controls (CMC) information to the Investigational New Drug (IND) application.

"The FDA has provided us very valuable advice on the design of the Phase 2 trial, and we are grateful for their comprehensive feedback," said Dr. Ray Takigiku, CEO of Bexion Pharmaceuticals. "Recurrent GBM remains an urgent unmet medical need, and we believe the initiation of a Phase 2 clinical trial of BXQ-350 for this devastating disease is a major milestone for both patients and Bexion. We are working diligently to incorporate the FDA’s comments into the IND, with the expectation of initiating the Phase 2 trial in the first quarter of 2020."