• Glioblastoma Multiforme (often known simply as GBM) is a fatal, incurable class of brain cancers that usually leaves patients only about 15 months to live once they are diagnosed
• A recent study by the Washington University School of Medicine found that the length of survivability appeared to improve when the standard chemotherapy regimen was given in the morning instead of the evening
• Brain cancer drug developer CNS Pharmaceuticals is also working on a solution to improve the quality of GBM care, seeing hope in its lead drug candidate, Berubicin, which showed promise in a small Phase 1 trial nearly 15 years ago
• One patient from that Phase 1 trial was still alive and cancer-free as of the most recent assessment in November
• CNS expects to begin a larger, multi-center potentially pivotal trial imminently (as well as collaborating on two Polish trials conducted by sublicensee partner WPD Pharmaceuticals), comparing Berubicin’s performance to the chemotherapy drug lomustine in hundreds of patients at nearly 60 oncology centers around the world

A new study recently completed by the Washington University School of Medicine in St. Louis has found that glioblastoma (“GBM”) brain cancer patients receiving the current chemotherapy standard of care had longer survivability rates if they switched from receiving treatments in the evening to receiving the treatments in the morning — encouraging news for patients with the incurable illness, as well as for neuro-oncology researchers attempting to develop improved treatments, including biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP).

“In my lab, we were studying daily rhythms in astrocytes, a cell type found in the healthy brain. We discovered some cellular events in healthy cells varied with time of day,” professor of biology Erik D. Herzog, PhD, stated in a Science Daily report on the study Herzog co-authored with professor of pediatrics and of neuroscience Joshua B. Rubin, MD, PhD (https://ibn.fm/TisXR).

“Working with Dr. Rubin, we asked if glioblastoma cells also have daily rhythms. And if so, does this make them more sensitive to treatment at certain times?” Herzog said. “Very few clinical trials consider time of day even though they target a biological process that varies with time of day and with a drug that is rapidly cleared from the body. We will need clinical trials to verify this effect, but evidence so far suggests that the standard-of-care treatment for glioblastoma over the past 20 years could be improved simply by asking patients to take the approved drug in the morning.”

GBM patients currently have an average 15-month survival rate after diagnosis of the illness. The Washington University study’s benefits were small — those who received the drug in the morning had an overall survival of about 17 months, while those who received it in the evening had an overall survival of about 13.5 months. But scientists hail any potentially significant increase in survivability as a step in the right direction for treating an incurable disease.

Furthermore, among a subset of patients with what are called MGMT methylated tumors, the study’s participants who took the drug in the morning averaged overall survival of about 25.5 months compared to 19.5 months — a difference of six months — for those who were medicated in the evening, the study’s authors reported.

CNS Pharmaceuticals is working to determine the efficacy of its lead drug candidate, Berubicin, in fighting off glioblastomas. In a small Phase 1 trial completed by another company well over a decade ago, 44 percent of patients saw their disease stabilize or improve. One Berubicin patient emerged cancer-free and as of the most recent medical assessment in November was still alive and still in remission nearly 15 years after the Phase 1 trial (https://ibn.fm/yZACY).

CNS now hopes to advance Berubicin to commercial production, with the start of its potentially pivotal clinical trial slated to begin this quarter. The global trial will compare Berubicin’s response to the effectiveness level of established chemotherapy drug lomustine in 243 GBM patients at about 35 clinical sites in the United States (https://ibn.fm/x8Zp2) and 25 more in foreign locations.

The company’s sublicensee partner, WPD Pharmaceuticals, will begin a similar Phase 2 clinical trial of Berubicin in Poland during the second quarter, with interim results anticipated by year’s end or early first quarter of 2022. WPD will also launch a Berubicin trial involving pediatric patients sometime later this year — the first significant investigation involving children with malignant gliomas (https://ibn.fm/CjWPj).

Anthracyclines as a class of chemotherapy have been used for over 60 years to treat a variety of cancers. … However, historically, anthracyclines have never been used to treat primary or metastatic brain cancers because scientists could not demonstrate that anthracyclines were able to cross the blood-brain barrier and achieve significant levels of activity in the brain,” CNS CEO John Climaco said in a webinar late last year (https://ibn.fm/d2OFK). “Berubicin may change that history because it is the first anthracycline that, based on limited clinical data, appears to cross the blood-brain barrier and achieve drug levels critical for efficacy against central nervous system malignancies.”

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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