- Houston-based CNS Pharmaceuticals is preparing to launch Phase 2 clinical testing of a novel brain cancer-fighting drug candidate called Berubicin early next year
- The biopharmaceutical company recently announced that a U.S.-based company contracted to make Berubicin has completed its production process and an Italian company working on a dual track in Europe is expected to finish by the end of the year
- Berubicin has shown promise in combatting Glioblastoma multiforme, an aggressive form of brain cancer commonly regarded as incurable. One participant in Berubicin’s Phase 1 trial remains cancer-free 14 years after the trial
- CNS Pharmaceuticals, with its sublicensee partner WPD Pharmaceuticals, is also preparing for 2 clinical trials in Poland including the first Phase 1 pediatric trial of Berubicin and a parallel Phase 2 trial in adults
The U.S. manufacturer for a novel anthracycline being tested by biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) as a potential new strategy in combatting an inexorable and ultimately fatal type of brain tumor has completed the manufacturing process for the drug candidate, known as Berubicin.
CNS Pharmaceutical engaged Pharmaceutics International, Inc. (“Pii”) to make Berubicin in the United States while BSP Pharmaceuticals S.p.A. (“BSP“) worked on a dual track to make Berubicin in Italy under the company’s strategy of supplying its upcoming Phase 2 trials with sufficient quantities of the orphan drug status product amid the risk of delays in production and shipping as a result of the ongoing COVID-19 pandemic.
Completion of both Pii’s and BSP’s manufacturing of Berubicin moves CNS Pharmaceuticals closer to completing its preparations for filing an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to fight glioblastoma.
Glioblastoma multiforme (“GBM”) is an aggressive brain cancer that has no known cure, however the Phase 1 trial of Berubicin in 2006 produced some promising results. Of 25 trial participants who were evaluated, 44 percent achieved what the company refers to as “statistically significant improvement in clinical benefit” (https://ibn.fm/tOnAN) while one patient has remained completely cancer-free as of the last evaluation on Feb. 20 — some 14 years after the initial trial phase.
Glioblastoma patients have a median survival rate of only 14.6 months from the date of the malignancy’s diagnosis, although the drug temozolomide has been shown effective in temporarily extending the lifespan of fewer than 40 percent of the GBM patients with a specific genetic variation. The persistent cancer tends to recur after surgery and to develop a resistance to temozolomide over time, making an effective therapy in treating it an attractive goal.
The orphan drug designation grants Berubicin certain benefits during its development and provides CNS with the potential for market exclusivity if the drug is approved for combatting malignant gliomas.
“We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner,” CEO John Climaco stated in the news release. “We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.”
As further evidence of the company’s progress toward advancing its clinical testing, CNS has contracted with Worldwide Clinical Trials as the research organization, Image Analysis Group as the imaging partner and with Berry Consultants as a biostatistical adviser for its Phase 2 trial design. CNS has also added renowned neuro-oncologist Dr. Patrick Wen to its Scientific Advisory Board.
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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