Monopar Therapeutics Shelves Development Of Validive For Radiation Therapy-Related Complication

  • Monopar Therapeutics Inc MNPR completed a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy for oropharyngeal cancer (OPC). 
  • The interim analysis included the first approximately 50% of the total planned patients to be enrolled. 
  • The independent Data Safety Monitoring Board (DSMB) informed that the trial did not meet the pre-defined threshold for the efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. 
  • The DSMB also reported that there were no safety concerns attributed to Validive. 
  • Monopar will be discontinuing the study along with the active development of Validive.
  • "While we are disappointed with the outcome of this study, we are now focused on re-deploying the financial and human resources previously dedicated to Validive to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes," said Chandler Robinson, CEO.
  • Monopar's Cash, cash equivalents, and short-term investments of $13.1 million are sufficient to provide a cash runway into Q1 of 2024.
  • Last month, the company opened enrollment for the fifth dose level cohort in the open-label Phase 1b camsirubicin Maximum Tolerated Dose trial for advanced soft tissue sarcoma, a diverse type of cancer that typically develops in the body's connective tissue
  • Price Action: MNPR shares are down 52% at $1.43 on the last check Tuesday.
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