On March 23, 2022 / BullFrog AI Holdings, Inc., a biopharmaceutical company focused on applying its proprietary Artificial Intelligence/Machine Learning platform to improve drug development and shorten clinical trial timelines, reported that it has entered into an exclusive license agreement with Johns Hopkins University for use of its novel formulation of mebendazole in treating cancer (Press release, Bullfrog AI, MAR 23, 2022, View Source [SID1234635364]).
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Under the terms of the agreement, BullFrog AI was granted an exclusive worldwide license to manufacture and use a novel formulation of mebendazole developed at the Johns Hopkins University (JHU) School of Medicine for treatment of cancer. This formulation is enriched in a polymorph of the drug which shows improved bioavailability, is particularly effective in crossing the blood-brain barrier, and has shown potent antitumor activity in multiple animal models of different cancers. In addition, it has been evaluated in a Phase I clinical trial in patients with high-grade gliomas (NCT01729260). The trial, an open-label dose-escalation study, enrolled 24 patients and demonstrated long-term safety and acceptable toxicity of mebendazole with adjuvant temozolomide in this population.
"We are excited to enter into this agreement with Johns Hopkins University for exclusive use of this unique formulation of mebendazole to treat cancer," said Vin Singh, Founder and CEO of BullFrog AI. "We look forward to pursuing development of this drug with Dr. Greg Riggins, Professor of Neurosurgery and Oncology at Johns Hopkins University and scientific advisor to BullFrog AI, for treatment of several devastating cancers. This drug enters our expanding pipeline as BF-222, and we will be engaging with the FDA in conversations about our clinical development plan in the near future. We are confident that bfLEAP, our proprietary AI/Machine Learning platform, provides us with an essential tool that we can leverage to efficiently develop this and other drugs that are being added to our pipeline to address unmet medical needs."
"Our Phase I clinical trial in patients with newly diagnosed high-grade gliomas showed that this novel formulation of Mebendazole is safe to use in combination with adjuvant temozolomide and provided valuable information regarding dosing," said Greg Riggins, MD, PhD. "I look forward to working with the team at BullFrog AI to pursue development of BF-222 for treating cancer."