CNS Pharmaceuticals Announces Call to Discuss FDA IND Approval and Phase 2 Trial for Berubicin

Rhea-AI Summary

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has announced a conference call and live webcast on December 18, 2020, at 8:30 AM ET to discuss its IND approval for Berubicin, aimed at treating Glioblastoma Multiforme (GBM). The planned Phase 2 clinical trial will begin by Q1 2021 in the U.S., with additional trials in Poland for pediatric patients. CNS holds exclusive rights to Berubicin, previously showing a 44% disease control rate in an earlier Phase 1 trial. Details for accessing the call and its replay are provided in the announcement.

Positive

• IND approval for Berubicin supports progression towards clinical trials.
• Successful Phase 1 trial reported a 44% disease control rate for Berubicin.

Negative

• Phase 1 results are based on a small sample size of 25 patients.
• No guarantee that Phase 2 trials will replicate Phase 1 results.

HOUSTON, Dec. 17, 2020 /PRNewswire/ -- 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 host a conference call and live webcast on December 18^th, 2020 at 8:30am ET to discuss its Investigational New Drug (IND) approval for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM), and planned Phase 2 Berubicin clinical trial.

Details of the webcast are below:
Date:	December 18th, 2020
Time:	8:30 AM ET
Link:	https://edge.media-server.com/mmc/p/rg8hxqpb

The dial-in numbers for the conference call are (800) 226-2188 for domestic callers and (602) 563-8462 for international callers. The conference ID is 6455799.

A replay of the call will be available following its completion through December 25^th, 2020. To access the replay, dial (855) 859-2056 for domestic callers and (404) 537-3406 for international callers and use the replay conference ID: 6455799.

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 the first quarter of 2021, 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.

 

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SOURCE CNS Pharmaceuticals, Inc.

FAQ

What is the purpose of the CNS Pharmaceuticals December 18 conference call?

The conference call will discuss the FDA IND approval for Berubicin and the planned Phase 2 clinical trial for GBM.

What is the significance of the IND approval for CNS Pharmaceuticals?

The IND approval allows CNS Pharmaceuticals to advance Berubicin into clinical trials aimed at treating Glioblastoma Multiforme, potentially opening market opportunities.

When is the Phase 2 trial for Berubicin expected to start?

CNS Pharmaceuticals expects to commence the Phase 2 clinical trial by the end of Q1 2021.

What were the results of the Phase 1 trial for Berubicin?

The Phase 1 trial showed a 44% disease control rate among 25 evaluable patients, with one patient achieving a complete response.

Will there be trials for Berubicin in pediatric patients?

Yes, a sub-licensee partner will undertake a Phase 2 trial in adults and a Phase 1 trial in pediatric GBM patients in Poland.