- Company will initiate a Phase II adult trial for Berubicin this year focused on patients with glioblastoma multiforme
- WPD, a CNS sub-license partner, will be commencing a parallel Phase II adult trial and the first-ever pediatric Berubicin trial
- Additional clinical trials are in the pipeline, including one for the company’s newest drug candidate, WP1244, and its effects on central nervous system tumors
Biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) recently took part in the H.C. Wainwright Bioconnect 2021 Virtual Conference, which took place January 11-14, 2021. CNS’s CEO John Climaco gave a presentation at the event, discussing how the clinical-stage biopharmaceutical company is developing novel treatments for primary and metastatic cancers of the brain and central nervous system (https://ibn.fm/7zYST).
CNS’s lead drug candidate is Berubicin, an anthracycline that, based on clinical data, can cross the blood-brain barrier in adults and reach the tumor cells of patients with brain cancer. As an organ targeted therapeutic, Berubicin demonstrated one durable complete response (not detectible on imaging) in a Phase I trial completed by Reata Pharmaceuticals, Inc. (NASDAQ: RETA) 14 years ago. CNS currently holds the worldwide exclusive licensing to the Berubicin drug and it recently obtained Investigational New Drug designation for it from the Food and Drug Administration.
In addition to Berubicin, the company’s current developmental pipeline includes a second promising drug candidate, WP1244. Licensed from The University of Texas MD Anderson Cancer Center in the first quarter of 2020, WP1244 is a DNA-binding agent that represents a novel class of potential therapeutics.
WP1244 is designed using anthracycline and distamycin-based scaffolds, creating small molecule agents binding extended sequences of DNA. In vivo testing demonstrated high uptake with WP1244 in the brain and subsequent antitumor activity in orthotopic models of the brain. The drug candidate is believed to be 500 times more potent than daunorubicin in inhibiting tumor cell proliferation. CNS entered into a Sponsored Research Agreement with MD Anderson Cancer Center in May 2020, related to WP1244.
CNS Pharmaceuticals, in partnership with company sublicensee WPD Pharmaceuticals, Inc. (CSE: WBIO) (FSE: 8SV1) currently has several clinical trials in different stages of preparation, including three glioblastoma multiforme (“GBM”) studies for Berubicin, scheduled to begin in Q1 2021. These include a randomized, controlled Phase II trial in the United States and another Phase II in Poland, conducted by WPD. Both these studies will be conducted with adult candidates. WPD will also begin the first-ever Phase I pediatric trial with Berubicin in Poland. Other studies in the pipeline for a future date include a potential Phase I trial for Berubicin with pancreatic and ovarian cancer and lymphoma patients as well as a potential Phase I trial for WP1244 for central nervous system tumors.
The primary focus for Berubicin has been patients with GBM, one of the most aggressive forms of brain cancer currently considered incurable. Each year, nearly 15,000 new GBM patients are being diagnosed in the United States. With the optimal therapy (surgical resection, chemotherapy, radiation), the median survival rate is only 15-23 months. Nearly 100% of GBM tumors recur after first-line therapy.
The Phase II trials for Berubicin in adult candidates are designed to be:
- Adaptive – the trial is designed to allow for modifications based on accumulated data from trial subjects
- Randomized – the trial randomizes which patients receive Berubicin versus the control group, eliminating the bias and increasing statistical significance
- Controlled – a control arm receiving the standard of care to compare the effectiveness of Berubicin against this standard, increasing the statistical significance
- Potentially Pivotal – the trials are designed to provide, pending positive results, the data necessary to support CNS’s request to the FDA for an expedited pathway to further development or approval of Berubicin
CNS believes that Berubicin has the potential to become a standard of care for GBM and other forms of brain cancer. The current first-line therapy includes temozolomide (“TMZ”). Nearly 40% of patients are genetically predisposed to respond to, becoming resistant to the treatment quickly. Berubicin could potentially be a second-line drug in these cases. The remaining 60% of patients may not be affected by TMZ, making Berubicin a potential first choice.
At the close of the presentation, Climaco said the company expects to see the first data for the Phase II trial in Poland reported during the third or fourth quarter of this year.
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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