HOUSTON, Dec. 17, 2019 | CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, (“Anthem”) an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.
This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.
“We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply,” stated CEO of CNS, John M. Climaco. “The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. 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 demonstrate in clinical trials that it can become the only effective anthracycline 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 was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.
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 www.cnspharma.com
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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