The poster, titled, 'A randomized, controlled trial of Berubicin, a topoisomerase II poison that appears to cross the blood-brain barrier (BBB), after first-line therapy for glioblastoma multiforme (GBM): Preliminary Results,' was presented by
'Berubicin has demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease. Based on the results we've seen preclinically and in the clinic thus far, including these updated results from our on-going potentially pivotal study, we remain optimistic that Berubicin may provide a much needed clinical benefit for GBM patients. We look forward to upcoming interim results that will evaluate Berubicin compared to the current standard of care (Lomustine) for second line therapy in this disease,' commented
As of the data cutoff for the poster, 151 patients had been enrolled, 105 on Berubicin and 46 on Lomustine. Enrolled patients received 7.5 mg/m2/day of intravenous (IV) Berubicin over 2 hours for 3 consecutive days (one cycle) every 21 days.
Previous results from this study were presented in
Summary of Updated Results from the Potentially Pivotal Study
All patients enrolled show comparable demographics for each arm, including age, gender, race, BSA, and KPS. In addition, patients have been stratified by MGMT methylation, allowing a reasonable comparison of efficacy based on this prognostic feature between the two groups. The unmethylated MGMT population comprises approximately 38% of all enrolled patients.
Approximately 50% of patients on both arms have completed the study, i.e. have participated in an end of treatment (EOT) visit, and withdrawal prior to EOT is relatively small, although almost twice the percent of patients in the Lomustine group compared to Berubicin have withdrawn. Primary reasons for withdrawal across both arms include Adverse Events, Physician Decision, Withdrawal by Patient, and Death as well as Other nonspecified reasons.
All grades of adverse events occurring in more than 10% of patients, as well as Grade 3-5 events, are presented in the poster, with the overall percentages similar in the Berubicin and Lomustine arms. In terms of myelosuppression (complete blood counts), neutrophil, and red blood cell count [anemia] reductions are also similar however thrombocytopenia seems to be higher in the Lomustine arm.
The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA.
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by
About
Forward Looking Statements
Some of the statements in this press 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 Company's timing of the interim analysis to occur before year end, the ability to continue to open additional clinical trial sites on a timely basis, and whether the FDA will recognize the Company's primary endpoint as a basis for approval. These statements relate to future events, future expectations, plans and prospects. Although CNS believes 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 Item 1A. 'Risk Factors' in CNS's most recently filed Form 10-K filed with the
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