- Neuro-oncology drug developer CNS Pharmaceuticals is completing an underwritten public offering of common stock shares and warrants in a bid to fund its upcoming Phase 2 trials for a candidate in fighting glioblastoma brain cancers
- CNS’s Phase 2 trials are scheduled to begin during Q1 of 2021, building on a Phase 1 trial in which 44 percent of patients saw improvement and one patient has survived cancer-free for nearly 15 years
- The company has designed an ambitious, adaptive trial that allows for an interim analysis of data and adjustments for efficiency in bringing the drug candidate, Berubicin, to hoped-for approval as a glioblastoma treatment
- CNS is aiming for FDA approval of an expedited development pathway to obtain maximum efficiency in its timeline
- A recent syndicated broadcast provided CNS with additional publicity, shining a spotlight on its achievements in obtaining FDA approval for Investigational New Drug (“IND”) status
The dawning of a new year is traditionally a time when people embrace the hope of new promise in defeating the disappointments of the past months, and the advent of 2021’s calendar is perhaps more so than ever as a growing number of vaccines against the worldwide COVID-19 pandemic begin to roll out to the public in tiered priority phases.
Also just over the new year’s horizon is the launch of Phase 2 testing by neuro-oncology biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) as CNS advances an ambitious agenda for developing a drug candidate that has shown promise in the fight against glioblastoma, a deadly brain cancer that has no known cure or longevity-building treatment.
CNS’s drug candidate Berubicin was the focus of another company’s Phase 1 safety trials nearly 15 years ago. Out of 25 trial participants in the 2006 analysis, 11 of them (44 percent) achieved “statistically significant improvement in clinical benefit” and one of them continued to survive completely cancer-free as of last Feb. 20, when the most recent patient evaluation was conducted. Since glioblastoma patients have a median survival rate of only 14.6 months from the date of the malignancy’s diagnosis, the patient’s response has excited interest in Berubicin’s potential (https://ibn.fm/8wVG3).
CNS recently conducted an underwritten public offering of 5 million shares of common stock as well as warrants to purchase up to 2.5 million shares of common stock, selling the stocks and warrants together at a combined public offering price of $2 per share and warrant to fund the upcoming Phase 2 trial as well as other research and development. CNS also granted the underwriter a 45-day option to purchase up to an additional 750,000 shares of common stock and/or 375,000 warrants to cover over-allotments, if any occur. The offering was expected to close on or about Dec. 28 (https://ibn.fm/4j2B5).
“Anthracyclines as a class of chemotherapy have been used for over 60 years to treat a variety of cancers. … However, historically, anthracyclines have never been used to treat primary or metastatic brain cancers because scientists could not demonstrate that anthracyclines were able to cross the blood-brain barrier and achieve significant levels of activity in the brain,” CEO John Climaco said during a recent webinar (https://ibn.fm/c1d6K). “Berubicin may change that history because it is the first anthracycline that, based on limited clinical data, appears to cross the blood-brain barrier and achieve drug levels critical for efficacy against central nervous system malignancies.”
The U.S. Food and Drug Administration (“FDA”) approved CNS’s Investigational New Drug (“IND”) application for Berubicin shortly before Christmas, and the company’s success in that endeavor was highlighted in a recent broadcast via NetworkNewsAudio (“NNA”) to thousands of syndication points (https://ibn.fm/F8N5C).
“Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” Climaco stated in a news release about the broadcast. “The Company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase 2 trial in the U.S., and 2 trials planned by our sublicensee WPD in Poland.”
The trial’s adaptive, stage-progressive design is intended to allow an interim analysis of the data for efficacy and then to allow an adjustment in patient population if necessary to make the most efficient and rapid use of time. CNS anticipates its trial strategy may potentially grant it an expedited pathway for development with the FDA if it continues to be successful.
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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