CNS Pharmaceuticals (NASDAQ: CNSP), a biotechnology company specializing in the development of novel treatments for brain tumors, received positive feedback from the U.S. Food and Drug Administration (“FDA”) for its Pre-IND (Investigational New Drug) meeting proposal to use Berubicin, a lyophilized drug product, in Phase II clinical trials. The FDA indicated, in response to CNS Pharmaceuticals’ previously-submitted Pre-IND request, that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. “We were encouraged by the initial feedback provided by the FDA 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,” CNS CEO John M. Climaco said in the news release. “We are continuing the process of preparing a new IND in accordance with the guidance we received from the FDA. 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 as we believe in Berubicin’s potential to offer oncologists the only anthracycline effective against brain cancer.”
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About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit the company’s website at www.CNSPharma.com.
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