Contract Pharma Staff10.20.20
CNS Pharmaceuticals Inc.’s U.S. manufacturer, Pharmaceutics International Inc., has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.
"Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year," stated John Climaco, CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."
The company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.
Clinical Trial Preparations
In addition to its manufacturing efforts, the company has also made progress in its clinical trial preparations. CNS recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group (IAG) as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The company has also added Dr. Patrick Wen, a neuro-oncologist, to its Scientific Advisory Board. The FDA granted the company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.
"Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year," stated John Climaco, CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."
The company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.
Clinical Trial Preparations
In addition to its manufacturing efforts, the company has also made progress in its clinical trial preparations. CNS recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group (IAG) as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The company has also added Dr. Patrick Wen, a neuro-oncologist, to its Scientific Advisory Board. The FDA granted the company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.
