CNS Pharmaceuticals has entered into a sublicense agreement with WPD Pharmaceuticals (WPD), a Polish corporation partially owned and controlled by Dr. Waldemar Priebe, the founder of the Company. The agreement grants WPD patent rights to research and develop, and manufacture or sell Berubicin in a limited territory comprised mainly of Eastern Europe and Central Asia. The Company is entitled to a 1% royalty on all commercial sales of Berubicin in these licensed territories.
As part of the agreement, WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin during the three year term of the agreement, which ends in August 2021. WPD plans to implement a multicenter pediatric Phase I clinical trial to determine maximum tolerated dose, and to determine the efficacy of Berubicin in Phase IB and II clinical trials in adults. WPD also plans to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs.
"We were extremely excited to enter into an agreement with WPD and to further explore the potential of Berubicin as an anthracycline internationally," said CEO of CNS, John M. Climaco. "Our agreement with WPD is truly a testament to our unrelenting commitment to pursuing treatments for glioblastoma around the world."
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.