CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Hits Key Milestone in Global GBM Clinical Trial with the Enrollment of First Patient in Spain

March 24, 2023 08:05:00
  • CNS recently enrolled the first patient in Spain in its ongoing global trial evaluating its lead drug candidate, Berubicin, for the treatment of recurrent glioblastoma multiforme (“GBM”)
  • This milestone is the culmination of years of meticulous planning and execution
  • The enrollment of this first patient follows the opening of 37 clinical trial sites of the 59 sites selected across the United States, Italy, France, Spain and Switzerland

CNS Pharmaceuticals (NASDAQ: CNSP), a clinical stage biotechnology company specializing in the development of novel treatments with a focus on brain cancer, glioblastoma and neuro-oncology, just enrolled its first patient in Spain, marking a key milestone in its GBM clinical study. Considered a potentially pivotal global trial for the company, the study seeks to evaluate Berubicin, the company’s lead drug candidate, for the treatment of recurrent glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer.

In what the CEO, John Climaco, regarded as an “encouraging enrollment pace,” CNS is on track to conduct its planned interim analysis set for mid-2023. This recent enrollment of the first patient in Spain is a major highlight of this progress (https://ibn.fm/peyQi).

“We continue to rapidly build momentum with patient enrollment across our clinical trial sites in Europe,” noted Climaco.

“We sincerely appreciate the institutions, clinicians and staff that are contributing to the conduct of this trial, and are extremely grateful to the patients that choose to participate,” he added.

In 2007, a prior developer released partial results from its Phase 1 clinical trial of Berubicin among patients with primary CNS malignancies (https://ibn.fm/VwP1V). Results, which showed 44% of patients exhibiting a clinical response, demonstrated a durable complete response, along with a stable disease in heavily pretreated patients. Results from this study would set the stage for subsequent research by CNS, leading up to the dosing of the first subject in the US in the third quarter of 2021 and the first subject in Europe in November 2022 at a site in France (https://ibn.fm/weOO6).

The enrollment of the first patient in Spain affirms CNS’ commitment to the study and highlights the years of meticulous planning and execution which have culminated in this huge milestone for the company. It followed the opening of 37 clinical trial sites of the 59 sites selected across the United States, Italy, France, Spain and Switzerland, all in a move to better understand the treatment of recurrent GBM.

CNS believes Berubicin to be the first anthracycline to appear to cross the blood-brain barrier. While it has shown incredible potential in the treatment of brain-related illnesses, CNS is exploring its potential for the treatment of other diseases, including metastatic pancreatic and ovarian cancers, as well as CNS lymphomas. By doing so, it looks to tap into the growing brain tumor therapeutics market, which is expected to hit $3.4 billion by 2025, up from $2.25 billion in 2019.

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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