An important regulatory milestone towards Phase 2 Cancer trial by Bexion Pharmaceuticals
Bexion Pharmaceuticals, Inc., which is focusing on oncology drug discovery. On Tuesday, the company announced the completion of an End of Phase 1 and the design of a Phase 2 clinical trial for BXQ-350. BXQ-350 is a synthetic form of the human glycoprotein saposin C. Also, discuss the design of a Phase 2 trial for BXQ-350. According to the company, BXQ-350 is the leading contender in treating recurrent Glioblastoma Multiforme (rGBM).
The FDA provided some guidance on different aspects of Phase 2 clinical trial. This trial is supposed to include 55-60 patients. Dr. Richard Schwen who is a regulatory consultant for Bexion. They said that meeting with the FDA is an important regulatory milestone for a new clinical improvement program. Also, the FDA conducts this type of meetings. Only when a significant amount of data for a drug is available. Bexion’s recent meeting indicated the FDA’s interest in BXQ-350 program. This will be a better opportunity for Bexion to complete the studies required for FDA approval. While designing the Phase 2 trial, learnings taken from Phase 1. Which included 93 patients. Among those patients 21 having rGBM. which is a higher planned dose and showed strong safety profile for BXQ-350. After receiving the feedback from USFDA, Bexion will submit a clinical trial report, statistical analysis plan of Phase 2 along with CMC (Chemistry, Manufacturing, and Controls). These documents need to submit in the Investigational New Drug (IND) application.
The CEO of Bexion Pharmaceuticals, Dr. Ray Takigiku said that FDA has suggested them with great advice regarding the design of phase 2 trial. Recurrent GBM is currently an urgent medical need. Dr. Ray believes that the initiation of Phase 2 clinical trial of BXQ-350 for this shattering disease will be a key milestone for both patients and Bexion. They are working persistently to include the FDA’s comments into the IND. As well as hoping for initiating the Phase 2 trial in the first quarter of 2020. Bexion Pharmaceutical has validated BXQ-350. Which are against the pre-clinical antitumor things in vitro and in vivo. This is mainly in the brain and solid tumors. which includes those that may cause brain metastases.