Monopar Therapeutics has made the difficult decision to discontinue its Phase III trial of Validive, its lead candidate, which had been in development to treat severe oral mucositis (SOM) in oropharyngeal cancer patients undergoing chemoradiotherapy.
After failing to meet the necessary efficacy markers during Phase IIb/III trials, a candidate has been dropped from consideration. This decision was announced in Monday’s press release.
An analysis conducted by an independent monitor revealed that Validive failed to reach the pre-determined 15% threshold in SOM prevention when compared to the placebo. Fortunately, no safety concerns were identified in the results.
At this time, there is no FDA-approved solution to prevent or treat this condition – a concerning reality that underscores the need for further research and innovation.
SOM (Stomatitis Mucositis) can be a devastating side effect for those undergoing radiation therapy, chemotherapy, chemoradiotherapy or hematopoeitic stem cell transplantation for cancer treatment.
This condition causes inflammation, swelling and painful ulcerations of the oral mucosa, and can severely impact a patient’s quality of life. SOM can be difficult to manage, but with the help of a specialized healthcare team, patients can learn to better manage and cope with the symptoms.
We are disappointed with the outcome of this study, but we remain undeterred in our commitment to advancing our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes.
To that end, we have re-allocated the financial and human resources originally earmarked for Validive to support these initiatives. At Monopar, we are committed to our mission of providing innovative treatments and therapies to improve patient outcomes.
Monopar is well on its way to success, boasting enough funds to support planned activities until the first quarter of 2024. With such financial stability and a clear plan for the future, this company is sure to continue on its upward trajectory.
Monopar is committed to advancing the field of precision medicine through its drug development pipeline, which includes Validive, a drug candidate targeting multiple myeloma, as well as other cancer treatments for soft tissue sarcoma and solid tumors.
By targeting specific molecular pathways that drive cancer growth and progression, Monopar seeks to provide more effective, personalized treatments for individuals battling this devastating disease.
Current Pipeline
As the Validive trial comes to a close, Monopar is already looking ahead to the future, with an array of promising candidates in development. From innovative treatments to cutting-edge therapies, Monopar is forging ahead to bring new and effective treatments to those in need.
Shares of Monopar Pharmaceuticals Inc. dropped drastically Tuesday morning in pre-market trading after news of their clinical trials for three potential cancer treatments failed to meet expectations.
The company had been developing MNPR-101 RIT, a late-stage preclinical antibody for radiopharmaceutical use in advanced cancers, MNPR-101ZR, a late-stage preclinical imaging agent for radioimmunotherapy, and MNPR-202, an early-stage camsirubicin analog, for various cancers.
Unfortunately, Phase Ib trials of Camsirubicin for the treatment of advanced soft tissue sarcoma were not successful, leading to the sharp drop in stock price.