- CNS Pharmaceuticals received approval from swissethics for its potentially pivotal study of Berubicin, a novel anthracycline for the treatment of Glioblastoma Multiforme (“GBM”)
- The approval is the first from a European Ethics Committee
- The company, which dosed the first patients in its Berubicin program in September, has selected multiple clinical sites across the U.S., Spain, France, Italy, and Switzerland
- CNS recently closed an $11.5 million private placement
- It intends to use the net proceeds to fund its clinical trials and preclinical programs, other R&D programs, and for general corporate purposes
Clinical stage biotechnology company CNS Pharmaceuticals (NASDAQ: CNSP) is celebrating a significant milestone as it journeys toward its potentially pivotal study of Berubicin for the treatment of Glioblastoma Multiforme (“GBM”). The company announced December 2 that it had received approval from swissethics, the umbrella organization of the cantonal Ethics Committees in Switzerland (https://ibn.fm/NisfL).
The first from a European Ethics Committee, the approval partly fulfills CNS’s goal of seeing Berubicin approved for the potential treatment of GBM globally. “This terrible disease does not discriminate on the basis of geography or anything else: Patients in Europe are as desperate as patients in the United States, and treating patients is not only why we do what we do, but how we do it as well. Driving patient enrollment is how we advance Berubicin’s development, and opening additional clinical sites around the globe is the pivotal piece that allows us to ramp up our efforts and move toward data,” stated CNC Pharmaceuticals CEO John Climaco.
So far, the company has selected tens of clinical sites across the United States, Spain, France, Italy, and Switzerland. In addition, CNS has already dosed the first patients in its Berubicin clinical development program, with a September 30, 2021 announcement noting that additional patient enrollment, randomization, and dosing was well underway in the United States (https://ibn.fm/qI7q2).
Berubicin mid last year received the U.S. Food and Drug Administration (“FDA”) Fast Track Designation as well as an Orphan Drug Designation (https://ibn.fm/PSSiU). Notably, the former designation helps facilitate the development and expedited review of drugs with the potential of treating serious conditions with high unmet medical needs, thereby underlining the seriousness of GBM, one of the most aggressive, deadly, and treatment-resistant cancers that form in the brain.
While chemotherapy medications are usually prescribed to patients living with the condition, results are underwhelming, if not devastating. According to CNS, the current standard of care is ineffective in about 60% of patients.
GBM is the most common malignant brain and central nervous system tumor accounting for 47.7% of all cases, according to data from the American Association of Neurological Surgeons (“AANS”). Its prevalence within a population of 100,000 people stands at 3.21. But despite this low incidence rate, the disease is lethal – only 40% of patients survive in the first year after diagnosis and 17% in the second year. Moreover, it can cause death in six months or less (https://ibn.fm/wU6vY).
In this regard, the recent approval, as well as CNS’s dosing efforts, offer a robust foundation for a potentially pivotal global trial.
The adaptive, multicenter, open-level, randomized, and controlled study will evaluate Berubicin in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy. About 243 patients with GBM after failure of standard first-line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine, a chemotherapy drug, in order to evaluate overall survival, the primary endpoint of the study.
It is noteworthy that Berubicin is the first anthracycline to cross the blood-brain barrier. It evidences effectiveness in treating GBM. “[Anthracycline] is a classic drug that’s been around for 60 years. It’s the first line therapeutic for all sorts of difficult-to-treat cancers. But no one has been able to get a drug like this across the blood-brain barrier until our Founder modified the classic anthracycline molecule to be more effective in crossing the blood-brain barrier,” said Climaco during an October interview with Proactive (https://ibn.fm/EJjMb).
Meanwhile, CNS Pharmaceuticals recently closed a previously announced private placement, priced at-the-market under Nasdaq rules, of over 12,105,264 shares of common stock (or pre-funded warrants in lieu thereof), raising gross proceeds of $11.5 million (before deductions). CNS intends to use the net proceeds to fund its clinical trials and preclinical programs, other R&D operations, and for general corporate purposes (https://ibn.fm/aTRJE).
For more information, visit the company’s website at www.CNSPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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