CNS moves into manufacturing berubicin
HOUSTON—CNS Pharmaceuticals, Inc. provided us with an update today, announcing that the company has completed the manufacturing strategy for berubicin, its lead drug candidate. Berubicin is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
In June, CNS Pharmaceuticals engaged U.S.-based Pharmaceutics International, Inc. (Pii) and Italian BSP Pharmaceuticals S.p.A. for the production of berubicin. CNS has decided to implement a dual-track drug product manufacturing strategy in order to mitigate both COVID-19 related risks, as well as diversifying its supply chain and reducing the risk of impacting the company’s clinical timeline.
CNS Pharmaceuticals’ decision to have both a European and a U.S. manufacturer will provide for localized availability of berubicin for the upcoming Phase 1 Pediatric and Phase 2 adult studies in Poland, and the U.S. Phase 2 trial.
“Our decision to contract both Pii and BSP represents a key part of our overall strategy to get Berubicin back into clinical trials as soon as possible,” said John Climaco, chief executive officer of CNS Pharmaceuticals. “Importantly, we felt it prudent to diversify our production strategy given the difficulty of predicting COVID-19 related risks and supply chain constraints. With our laser focus on initiating our Phase 2 trial by the end of the 2020, we believe the decision to engage both manufacturers positions us optimally to continue to execute on our timeline and reduce the risks of delays.”
CNS has completed synthesis of berubicin active pharmaceutical ingredient (API), and shipped API to Pii and BSP. The two companies will prepare an injectable form of berubicin ready for clinical use, which will allow CNS to initiate clinical studies in GBM patients.
At the end of June, CNS Pharmaceuticals announced that it had engaged Berry Consultants, a leading clinical statistical consulting group, to advise the company ahead of its Phase 2 trial for berubicin. Berry Consultants specializes in the Bayesian approach to medical statistics. Founder Dr. Don Berry is a professor in the Department of Biostatistics at The University of Texas MD Anderson Cancer Center. He has designed and supervised the conduct of hundreds of clinical trials, including glioblastoma, GBM-AGILE and pancreatic cancer.
“We are extremely excited to have Berry Consultants, a renowned clinical statistical consulting company, advise on our Phase 2 trial design. We believe the company’s unparalleled expertise and innovative approach to clinical trial design will prove invaluable in the construction of our Phase 2 trial for Berubicin,” Climaco noted in a press release. “With the support of Dr. Berry and his team’s deep experience and advice, we look forward to further driving the development of our lead candidate, Berubicin, and initiating our Phase 2 trial in the fourth quarter of this year.”
Also in June, CNS Pharmaceuticals received word that the U.S. Food and Drug Administration had granted Orphan Drug Designation for berubicin for the treatment of malignant gliomas.
“In the Phase 1 trial of Berubicin to treat glioblastoma, one of the world’s most aggressive cancers, under a prior developer, 44% of the patients demonstrated a significant improvement in progression free survival, and one patient experienced a complete response,” explained Climaco.
“We are excited to continue to drive the development of Berubicin and work towards addressing a critical unmet medical need. Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe Berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas,” added Dr. Sandra Silberman, chief medical officer of CNS.