(CNSP) – Polish Regulatory Authority Issues Positive Opinion For CNS Pharma’s Brain Cancer Candidate

1 min read
  • CNS Pharmaceuticals Inc’s (NASDAQ: CNSP) partner WPD Pharmaceuticals received a favorable opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland, for its planned upcoming Berubicin trial in adults with Glioblastoma Multiforme (GBM) under the WPD-201 Clinical Trial Protocol.
  • CNS has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol.
  • WPD plans to initiate both Berubicin Phase 2 adult GBM trial in the first half of 2021 and a pediatric malignant glioma Phase 1 clinical trial in 2021. Around 60% of the program budget is expected to be funded by the reimbursement grant.
  • In December last year, the FDA signed off CNS Pharma’s IND for Berubicin. Phase 2 will start in the first quarter of 2021 to evaluate the efficacy and safety of Berubicin in the treatment of adults with GBM who have failed first-line therapy. 
  • Berubicin is the Company’s novel anthracycline candidate for the treatment of many serious oncology indications, currently in development to treat GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights in select territories in Europe and Asia to Berubicin.
  • Price Action: CNSP is down 3.06% at $3.17 in market trading hours on last check Thursday.