- Poland trials will include the first ever Phase 1 trial for pediatric patients suffering from glioblastoma multiforme
- CNS Pharmaceuticals has made significant strides in its Berubicin manufacturing process due to its dual-track approach and expects to begin production of its drug candidate at Pharmaceuticals International during the third quarter of 2020
- The Company’s CFO recently acquired 142,000 shares of common stock in the open market, a move indicative of his confidence in the success of Berubicin clinical trials and its positive impact on the global brain tumor therapeutics market
CNS Pharmaceuticals (NASDAQ: CNSP) is moving forward with clinical trials of its innovative leading drug candidate Berubicin in Poland after sub-licensee WPD Pharmaceuticals, Inc. (CSE: WBIO) (FSE: 8SV1) has identified a contract research organization to coordinate and supervise Phase 1 and Phase 2 trials in the European country (http://ibn.fm/iFYph).
WPD Pharmaceuticals, which has a sublicense agreement with CNS which gives it commercial rights to Berubicin in selected territories in Europe and Asia, announced that it engaged the services of Worldwide Clinical Trials to supervise Phase 1 and Phase 2 trials. Worldwide Clinical Trials is a full-service drug development company serving the pharmaceutical and biotechnology sectors, from early phase and bioanalytical sciences to Phase 2 and 3 trials and peri-approval studies.
Berubicin is proposed for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. Berubicin also has potential to treat other central nervous system malignancies. In Poland, WPD will conduct the first-ever Phase 1 trial in pediatric GMB patients and an adult Phase 2 trial. Sixty percent of the program will be funded by WPD via a $6 million reimbursement grant from the EU/Polish National Center for Research and Development.
News of the Poland clinical trials comes after CNS Pharmaceuticals announced the achievement of key milestones in its Berubicin manufacturing process and after the acquisition of common stock an officer of the company. The company’s Chief Financial Officer, Christopher Downs, filed an SEC Form 4 on August 25, 2020. SEC Form 4 shows that he acquired 142,000 in common stock through multiple trades at prices ranging from $1.84 to $2.30 (http://ibn.fm/BGb6w).
The common stock acquisition is a bold expression of the confidence Downs has in Berubicin trials and the impact of its lead drug candidate on a growing brain tumor therapeutics market. It is estimated that the global brain tumor therapeutics market will reach $3.4 billion by 2025, growing at a CAGR of 7.2 percent (http://ibn.fm/2Lfjl). Due to the lack of specific therapies that deliver the drugs through the blood-brain barrier, the survival rate for most patients past three years is only 2-5%. Berubicin could potentially change the survival rates with the infiltration of the blood-brain barrier.
The filing occurred on the same day the company provided an update on their Food and Drug Administration filing for the Investigational New Drug (“IND”) application. CNS plans to file the IND application during the fourth quarter of 2020. At the time, the company also announced the completed synthesis of Berubicin active pharmaceutical ingredient (“API”). It was shipped to both manufacturers CNS is working with — U.S.-based Pharmaceutics International Inc. (“Pii”) and Italy-based BSP Pharmaceuticals S.p.A. (“BSP”) — for the preparation of an injectable form of the drug for clinical use.
On September 3, 2020, the company announced significant advancements in its Berubicin manufacturing process due to its dual-track manufacturing strategy, which helped mitigate any possible delays caused by COVID-19, as well as diversify the supply and localized availability of the drug (http://ibn.fm/r7scX). With the API in hand, Pii and CNS have an agreed-upon manufacturing procedure and packaging components. The selection of a sterile filter manufacturer has also been made. The lyophilization cycle has been successfully simulated by CNS and Pii, including a completed draft of the batch record.
CNS believes that the manufacturing of Berubicin will begin at Pii during the third quarter of 2020. With this success, CNS hopes to start its Phase 2 trials in the United States during the first quarter of 2021 as well.
“As we prepare to initiate our upcoming Berubicin clinical trials, our execution both on the clinical and manufacturing fronts remain paramount to our success,” CNS Pharmaceuticals CEO John Climaco said. “We continue to be encouraged as our partner Pii has now delivered upon many of the critical steps necessary to ensure the quality and availability of Berubicin. We look forward to keeping you updated on our progress as we continue our preparations to submit an IND for Berubicin during the fourth quarter of this year.”
For more information, visit the company’s website at www.CNSPharma.com.
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