WPD Pharmaceuticals’ Brain Cancer Drug Received Positive FDA Pre-IND Guidance

WPD Pharmaceuticals has provided an update that through its license partner, CNS Pharmaceuticals, it received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.

Berubicin was developed at the largest cancer treatment and research institute in the world, and has been shown to get across the blood brain barrier and kill brain tumor cells not reachable by other therapies. Berubicin may become an effective treatment against glioblastoma, the most aggressive type of brain cancer.

In its positive response to the previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.

"The positive feedback from the FDA is encouraging as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time," Mariusz Olejniczak, CEO of WPD, said. "We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide. We believe in Berubicin's potential to offer oncologists the only anthracycline effective against brain cancer."

Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.

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