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news.Bradmer Pharmaceuticals has received notification from the FDA that it may proceed with the launch of its proposed Phase III trial evaluating Neuradiab as a front-line therapy for glioblastoma multiforme, the most common and advanced form of primary brain cancer.
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To support this approval, Bradmer previously submitted the Chemistry, Manufacturing and Control (CMC) dossier, as well as the clinical protocol and related trial design and execution documents to the FDA for review. The FDA determined that the CMC dossier and the clinical protocol contained the necessary information to support the execution of the Phase III multi-center clinical trial developed by Bradmer.
The Phase III trial, named the GLASS-ART trial, is currently screening for patients and will investigate Neuradiab as an adjuvant therapy to surgery, external beam radiation and temozolomide in 760 patients with newly diagnosed glioblastoma multiforme. The randomized trial is expected to be conducted at leading brain tumor treatment centers across the US.
Alan Ezrin, president and CEO of Bradmer, said: “With this positive response from the FDA, we are now in a position to begin treating patients with this potentially vital new therapy for glioblastoma multiforme.”