CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Expanding Scope of Potentially Pivotal Study as Part of Clinical Program to Develop GBM Treatment

• CNS Pharmaceuticals is undertaking a Berubicin clinical development program targeting glioblastoma multiforme (“GBM”), the most common and devastating primary malignant brain tumor
• GBM has an incidence rate of 3.21 per 100,000 in the U.S. and up to 5 per 100,000 globally, with studies noting that the latter figure is rising
• CNS recently received approval for a protocol amendment as part of its potentially pivotal study evaluating the efficacy and safety of Berubicin for the treatment of GBM
• The amendment expands eligibility for its potentially pivotal study to patients who have received additional treatments as part of the first-line therapy
• CNS is looking to expand the scope and outreach to patients for the multicenter trial by opening clinical sites globally

Biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) recently marked an important milestone in its pursuit of novel treatments for primary and metastatic cancers in the brain and central nervous system, one of which is glioblastoma multiforme (“GBM”), an area of significant unmet medical need. CNS is currently recruiting patients for a potentially pivotal Phase II study evaluating the efficacy and safety of Berubicin, its lead drug candidate for treating GBM. The open-label, multicenter, randomized, parallel study, which commenced in Spring 2021 with an estimated primary completion date of Fall 2024, is expected to have an enrollment of more than 200 adult patients.

With a median survival from initial diagnosis of less than 15 months and a 2-year survival rate of 26-33%, GBM is the most common and devastating primary malignant brain tumor affecting adults. In the United States, GBM has an average annual age-adjusted incidence rate of 3.21 per 100,000 population, based on data collected from 2011 to 2015 (https://ibn.fm/Ebw4G). Globally, the incidence is higher, up to 5 per 100,000 persons, and is rising by the day, according to various studies (https://ibn.fm/Xan4i). Given the seriousness of this condition and its rising incidence rate, the FDA granted a Fast Track Designation for Berubicin mid-last year.

“Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly, and treatment-resistant type of cancer that forms in the brain,” said CNS Pharmaceuticals CEO John Climaco of the Fast Track Designation (https://ibn.fm/wIDyF). “With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease.”

And with a recently announced approval of the protocol amendment, CNS’s Berubicin clinical development program received an additional boost. The amendment expands eligibility for its potentially pivotal study to patients who have received additional treatments as part of the first-line therapy (https://ibn.fm/pXfoh).

The key objectives of the amendment, according to John Climaco, were based on the feedback the company received from investigators as well as additional consideration of the needs of patients in the study. Additionally, it incorporated a recent World Health Organization (“WHO”) classification of GBM that allows CNS to accurately position its program for success. Following the approval, the potentially pivotal study will now include an additional group of patients who may have undergone multiple procedures as their initial treatment. Typically, surgery is the initial therapeutic approach followed by radiotherapy, which has long been used to augment local control and survival.

Moving forward, the company intends to expand the study into additional countries. As a multicenter clinical trial, the study will recruit patients from the United States and Europe. Beyond the U.S., CNS has so far received regulatory approval to pursue patient recruitment in France, Switzerland, and Spain. 

“With the recent regulatory authority approvals received in Europe, we are currently on the cusp of opening clinical sites globally, including France, Italy, Spain, and Switzerland, to expand the scope and outreach to patients for this trial. We remain dedicated to driving this study forward and ultimately hope to provide a much-needed option for treatment in GBM as a safe and effective therapy,” commented Sandra L. Silberman, M.D., Ph.D., the Chief Medical Officer of CNS Pharmaceuticals.

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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