On July 2, 2019 Monopar Therapeutics Inc., an oncology-focused biopharmaceutical company, and the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS) reported that they have entered into a clinical collaboration agreement to conduct a Phase 2 clinical trial to evaluate Monopar’s investigational drug Camsirubicin in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, JUL 2, 2019, View Source [SID1234537364]).
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Soft tissue sarcomas are a diverse and aggressive class of cancers with generally poor survival outcomes. They usually develop in the connective tissue of the body, which include cartilage, muscles, nerves, bones, deep skin tissues, fat and blood vessels. Currently, there are limited therapeutic options for advanced sarcoma patients, with median overall survival of 12-16 months. The most effective first-line drug for ASTS is doxorubicin, a drug which, while effective, has to be stopped after six to eight cycles of treatment due to the heart damage it causes at higher cumulative doses.
Camsirubicin is being developed to replace doxorubicin as first-line therapy for ASTS. "The cumulative dose limitation of doxorubicin often results in advanced sarcoma patients receiving suboptimal dosing for the treatment of their cancer. Even if they are responding, they have to stop doxorubicin treatment permanently," said Andrew Mazar, Ph.D., Monopar’s chief scientific officer. "Camsirubicin has been specifically designed to avoid the irreversible heart toxicity while retaining the anticancer activity of doxorubicin, thus removing the limitations on cumulative dose."
Under the collaboration with Monopar, GEIS will lead a multi-country, randomized, open-label Phase 2 clinical trial to evaluate Camsirubicin head to head against doxorubicin in patients with ASTS. "The favorable safety profile and efficacy observed in previous clinical studies of Camsirubicin suggest that it could be dosed higher and longer than doxorubicin, which may improve the outcomes for ASTS patients," said Dr. Claudia Valverde, president of GEIS. "Patients with ASTS have few treatments available that improve overall survival, and our network of sarcoma referral centers in Spain and across Europe are eager to evaluate Camsirubicin’s ability to improve patient outcomes."
Enrollment of the trial is expected to begin in early 2020 and will include approximately 170 ASTS patients. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival and incidence of treatment-emergent adverse events. GEIS will be the study sponsor with support from Monopar.
"We are very excited to be entering into this clinical collaboration with GEIS. They have an impressive track record of working on sarcoma studies with many of the leading biotech and global pharma companies, and with working on many of the drugs that have been tested for the treatment of ASTS," said Chandler Robinson, MD, chief executive officer of Monopar.