CNS PHARMACEUTICALS: Announces Adaptive Trial Design For Berubicin Phase 2 Clinical Trial To Be Submitted for FDA Review


CNS Pharmaceuticals, Inc. issued the following announcement on Nov. 9.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will be issuing a video update on November 12th, 2020 at 4:30pm ET to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer, currently considered incurable. The discussion will be moderated by Robert LeBoyer, Managing Director of Equity Research at Ladenburg Thalmann & Co., Inc.

The Company plans to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA), which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1. The Phase 2 trial will randomize patients to Berubicin or standard of care. This upcoming trial will include interim assessments that will evaluate the comparative safety and effectiveness of these treatments with an adaptive design intended to complete a thorough investigation into Berubicin as expeditiously as possible.

Details of the webinar are below:

Date: November 12th, 2020

Time: 4:30 PM ET

Link: https://cnspharma.com/webcast-november-2020/

About CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

For more information, please visit www.CNSPharma.com.

Original source can be found here.

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