CNS Pharmaceuticals Inc. (NASDAQ:CNSP) has its lead product candidate, Berubicin being studied for the treatment of glioblastoma multiforme (GBM). A couple of months ago, the company received an Orphan Drug Designation from the FDA for the anthracycline anticancer drug formerly known as RTA 744. This was after an investigation in a phase 1 study of patients with glioblastoma multiforme. From the 25 enrolled patients, 44%, which represents 11 of them, demonstrated significant improvement in progression-free survival (PFS).
The Orphan Drug Designation for berubicin provided the company with a platform for pursuing a strategic plan of initiating a phase 2 trial. This eventually took place, and from the results, CNS says it is anticipating to submit an Investigational New Drug application (IND) to the FDA. Meanwhile, clinical trials in early 2021.
The Establishment of Clinical Trial Design and Implementation
Worldwide Clinical Trials (Worldwide) is the contract research organization (CRO) engaged by CNS to carry out the upcoming Berubicin clinical trials. It will provide both proactive insights and operational support, given that it has the necessary expertise in therapeutic areas such as CNS disorders and oncology. Berry Consultants will offer the necessary advisory support on the Phase 2 trial design in preparation for the submission of the IND.
“We are extremely encouraged by the consistent progress we have made in preparation for our upcoming Berubicin clinical trials…the CNS team is deeply experienced in the design and execution of clinical trials…’’ the CEO of CNS Pharmaceuticals, John Climaco, commented.
Key Advancement by CNS in Drug Manufacturing
The company is anticipating to submit the IND for Berubicin in the fourth quarter of this year. This will be a key milestone among many others it has achieved in the advancement of drug manufacturing. Its goal is to ensure the availability of quality products manufactured under safety standards.
The engagement of international pharmaceuticals has placed the company at a competitive level. The strategy is believed to be working well and is also applied largely in the development of COVID-19 related vaccines. It will also provide CNS with the potential of accessing international markets once it has obtained the approval of Berubicin.