• Biotechnology developer CNS Pharmaceuticals is preparing, with its partner WPD Pharmaceuticals, a global set of Phase 2 trials for its drug candidate Berubicin, which has shown promise in combating the effectively fatal glioblastoma multiforme (“GBM”) brain cancer
• Since another company conducted Phase 1 safety trials for Berubicin 14 years ago, one patient has survived cancer-free while two others saw reductions in tumor size of up to 80 percent
• The Phase 2 trials will build on the Phase 1 results, conducting targeted testing that offers side-by-side comparison between Berubicin and chemotherapy drug lomustine in real time beginning next year
• The company is also preparing with WPD to conduct the first Phase I trials of Berubicin in children in Europe
• CNS Pharmaceuticals officers recently participated virtually in the annual Society for Neuro-Oncology (“SNO”) Scientific Meeting and Education Day to promote their work and discuss the progress of clinical trials

While the world’s attention remains occupied with developments related to the global coronavirus pandemic that has infected about 60 million people and claimed the life of nearly 1.5 million of them (https://ibn.fm/ki9Vf), a dedicated group of researchers continues to pursue breakthroughs on the nearly always fatal glioblastoma multiforme (“GBM”) type of brain cancer. Recently, the Society for Neuro-Oncology (“SNO”) held its 25th Annual Scientific Meeting and Education Day to spotlight the efforts of over 2,600 researchers and clinician scientists from more than 40 countries in researching and treating GBM and similar brain cancers (https://ibn.fm/WCLpE).

CNS Pharmaceuticals (NASDAQ: CNSP) appeared at the virtual conference through a joint sponsorship with WPD Pharmaceuticals, staffing a booth in the virtual exhibit hall while Dr. Patrick Wen, a member of CNS’s Science Advisory Board, participated in a panel discussion on clinical trials during the plenary session Nov. 20, and in online poster presentations throughout the three-day event (https://ibn.fm/L99MV).

CNS Pharmaceuticals is preparing to launch a Phase 2 trial of its leading drug candidate, Berubicin, an anthracycline that has demonstrated significant potential in appearing to effectively cross the blood-brain barrier and effectively targeting central nervous system malignancies.

The medical science companies presenting their progress toward a more effective treatment of glioblastomas at the SNO conference generally focused on the safety and tolerability of using their drug candidates in animals or early-stage human trials. CNS appears to have an advantage in that Berubicin not only demonstrated safety in the Phase 1 trials conducted by another company 14 years ago; the clinical benefit response of stable disease or better was 44 percent with one patient who still remains alive and cancer-free and another two patients whose tumors shrunk by up to 80 percent.

CNS has obtained Orphan Drug Designation (“ODD”) for Berubicin in treating malignant gliomas and announced Nov. 17 that it has now filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) which has been accepted for review (https://ibn.fm/C99tn).

The company’s Phase 2 trial will recruit 243 patients for side-by-side, real-time analysis of Berubicin’s performance against the chemotherapy standard of care drug lomustine. The trials will take place on a global scale, administering Berubicin to 162 tumor patients and Iomustine to the other 81 in about 60 study centers scattered across North America, Europe and the Asia-Pacific region, company officers said in a November webinar (https://ibn.fm/pbPBn).

“We are evaluating responses defined as a decrease in the size of the tumor, as well as stability of the disease defined as no further increases in the size of the tumor once the patient is put on study, as well as the time to progression of these tumors and importantly overall survival of the patients,” CMO Dr. Sandra Silberman said during the webinar.

Existing treatments mostly avail themselves of surgery and the drug temozolomide, which has been shown effective in temporarily extending the lifespan of fewer than 40 percent of GBM patients with a specific genetic variation. But overall, glioblastoma patients have a median survival rate of only 14.6 months from the date of the malignancy’s diagnosis as the cancer recurs and resists new interventions — a significant reason why the Berubicin trial participant’s survival for 14 years without cancer is so exciting.

CNS expects the trial enrollment to take two to two and a half years with funding occurring in stages as critical benchmarks are achieved. CEO John Climaco said the trial could potentially lead Berubicin toward an expedited regulatory pathway, which would save time and money in the long run.

CNS is also simultaneously pursuing a first-ever Phase I Berubicin safety trial in Poland for children who have the GBM tumor and have run out of other medical options. This trial is being conducted by WPD Pharmaceuticals, a CNS sub-licensee.

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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