- CNS Pharmaceuticals recently announced it had enrolled the first patient in Switzerland as part of its ongoing potentially pivotal global GBM trial
- The adaptive, multicenter, open-label, randomized controlled trial is evaluating Berubicin for the treatment of recurrent GBM, the most common primary brain cancer, compared to Lomustine, the current standard of care
- The enrollment moves the company closer to its goal of undertaking an interim analysis expected in the third quarter of 2023
- So far, CNS Pharmaceuticals has opened over 40 of 59 planned clinical trial sites selected across Switzerland, Spain, France, Italy, and the U.S.
- As an aside, the company announced it does not hold any deposits or investments at the now-collapsed Silicon Valley Bank (“SVB”)
CNS Pharmaceuticals (NASDAQ: CNSP), a clinical-stage biotechnology company specializing in the development of novel treatments, recently reported the enrolment of the first patient in Switzerland as a participant in its ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (“GBM”) (https://ibn.fm/60iyl).
An aggressive, fast-growing primary brain tumor, GBM accounts for 45.2% of primary malignant brain and central nervous system (“CNS”) tumors, making it the most common primary brain cancer. Unfortunately, GBM has largely remained an incurable disease with a poor prognosis – it has a median survival of 15 months, and only 5.5% of the patients survive to the fifth year after diagnosis. In the intervening period, the patients usually experience symptoms such as memory problems, personality changes, vision and language difficulties, headaches, seizures, and even paralysis as the tumor grows, exerting pressure on surrounding brain cells (https://ibn.fm/gsAoV).
To preserve neurological function, reduce the chances and instances when the patients experience the aforementioned symptoms, and improve survival, safe surgical resection is preferred, following which the patients undergo radiotherapy and chemotherapy. This set of treatments – surgery followed by radiotherapy and chemotherapy- is the standard first-line therapy. Often, however, given the disease’s aggressive nature, GBM has a high rate of recurrence, even after completion of first-line therapy.
For this reason, CNS Pharmaceutical’s adaptive, multicenter, open-label, randomized controlled study targets adult patients with recurrent GBM after failure of standard first-line therapy. In addition, the study will also enroll patients who have received additional treatments as part of the first-line therapy in recognition of the complexity of new agents introduced as a component of this therapy.
The study will compare Berubicin, a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, to Lomustine, the current standard of care (“SOC”). More specifically, it will assess the effect of Berubicin compared with Lomustine on Overall Survival (“OS”), its primary endpoint measure, one that is recognized by the Food and Drug Administration (“FDA”) as the basis for approval of oncology drugs.
In the meantime, before completing assessments on all enrolled participants, CNS Pharmaceuticals aims to undertake an interim analysis expected sometime in the third quarter of 2023. This pre-planned, non-binding futility analysis will include additional evaluation of safety and secondary efficacy endpoints.
Thus, the latest enrollment continues the company’s progress toward the interim analysis. It follows a February 7 announcement that the first patient in Spain had been enrolled (https://ibn.fm/QBPv2). Moreover, late last year, on November 2, CNS announced the enrollment and dosing of the first patient in France (https://ibn.fm/fNx2S). As a result of this expanded enrollment, CNS Pharmaceuticals has so far opened over 40 out of 59 clinical trial sites selected across Switzerland, Spain, France, Italy, and the U.S.
“The active enrollment we continue to build across our clinical trial sites in Europe is incredibly encouraging. Our team is laser focused on getting additional clinical trial sites online so that we can continue to advance toward our planned interim analysis,” John Climaco said of the latest enrollment in Switzerland.
Meanwhile, CNS Pharmaceuticals also reported it does not hold any deposits or investments at Silicon Valley Bank (“SVB”) (https://ibn.fm/2rwIo). SVB was on March 10 closed by the California Department of Financial Protection and Innovation, signaling its collapse, with the Federal Deposit Insurance Corporation (“FDIC”) subsequently appointed receiver and assuming control of the bank (https://ibn.fm/y1fMD).
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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