- CNS Pharmaceuticals holds the exclusive worldwide license to the Berubicin chemical compound
- Berubicin is CNSP’s lead, novel anthracycline candidate for the treatment of glioblastoma multiforme (“GBM”) that was the subject of a previously conducted Phase 1 clinical trial, which had a clinical benefit response rate of 44%
- CNSP has sublicensed Berubicin to WPD Pharmaceuticals in 31 countries primarily in eastern Europe and western Asia
- WPD plans to conduct a Phase 2 trial in adults with GBM and a Phase 1 trial for pediatric patients with malignant gliomas
- CNSP intends to conduct its own Phase 2, potentially pivotal, trial in s GBM patients who have failed first-line therapy and is on track to commence the study in March 2021
- Both WPD and CNSP have received favorable opinions for their respective protocols to be used in their clinical trials
The Lower Silesian Medical Chamber Ethics Committee in Wroclaw, Poland recently gave WPD Pharmaceuticals (CSE: WBIO) (Frankfurt: 8SV1) (“WPD”), CNS Pharmaceuticals, Inc.’s (NASDAQ: CNSP) sublicensee in Europe and Asia for Berubicin, a positive opinion for its WPD-201 Clinical Trial Protocol to be used in the planned forthcoming Berubicin clinical trial in adults with glioblastoma multiforme (“GBM”).
Notably, a regulatory body within a given territory – in this case, Poland – shares a positive opinion to ascertain that a study, through its protocol, respects participants’ dignity, rights, safety, and well-being.
This new development, which CNSP and WPD announced in a news release recently, set the wheels in motion for the eventual approval of WPD’s studies – a multicenter Berubicin Phase 2 adult GBM trial and a multicenter pediatric Phase 1 malignant glioma trial.
“This is an important step for WPD,” commented Mariusz Olejniczak, WPD’s CEO (https://ibn.fm/PH9lC). “From both a project and sublicense agreement point of view. After receiving the Central Ethics Committee’s positive opinion, we are planning to submit our application to the Office for Registration of Medical Products, Medical Devices, and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive an approval within three months from submission.”
WPD plans to start the Phase 2 trial in the first half of 2021 and the Phase 1 trial later in 2021. This will bring the total number of Berubicin clinical trials to be started in 2021 to three as CNSP will also conduct its Phase 2 trial. CNSP’s Phase 2 trial will evaluate the efficiency and safety of Berubicin as a treatment for adults with GBM who have failed first-line therapy.
CNSP slated its study for March= 2021, having received approval from the U.S. Food and Drug Administration (“FDA”) for its Investigational New Drug (“IND”) application and a study level Central IRB approval from the Central IRB for the CNS-201 Clinical Trial Protocol.
“We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin,” John Climaco, the CEO of CNS Pharmaceuticals, said. “We look forward to continuing our trial preparations, as well as WPD’s planned submissions to the Polish Competent Authority”.
Berubicin is CNSP’s novel anthracycline (a chemotherapy drug), which is notably unique from other anthracyclines. Historically, anthracyclines have never been used to treat primary or metastatic brain cancers because they did not have any demonstratable ability to cross the blood-brain barrier and achieve significant levels of activity in the brain. However, based on limited available data, it appears that Berubicin can cross the barrier (https://ibn.fm/XnOxj).
Its efficacy was demonstrated in Phase 1 clinical trial completed in 2006 by Reata Pharmaceuticals, Inc. – CNSP has since acquired all the data from this trial and is currently the exclusive Berubicin license holder, subject to the sublicense agreement with WPD. The Phase 1 trial, which has 25 participants evaluable, had an overall response rate (clinical benefit of stable disease or better) of 44%. Notably, one patient’s experience with the treatment was durable as they have remained cancer-free for well over a decade through the most recent clinical evaluation on November 6, 2020. The Phase 1 trial had a limited sample size, so there can be no guarantee that similar results will be realized in the subsequent trials, but it is promising. CNSP’s Phase 2 trial will have an estimated enrollment of over 200 participants (https://ibn.fm/C6426).
CNSP is a clinical-stage biotechnology company that focuses on developing new treatments for the brain and central nervous system’s primary and metastatic cancers. Berubicin, the Company’s lead anthracycline drug candidate, is a promising treatment for glioblastoma multiforme (GBM). WPD is a biotechnology company that focuses on researching and developing medicinal products involving biological compounds and small molecules in the oncology and virology fields. WPD holds a Berubicin sublicense for the European and Asian markets.
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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