Povulis: Proof of Concept Preclinical Data on Ovarian Protection During Chemotherapy Published.
Provulis announced today that preclinical data from animal studies on its lead pipeline candidate, recombinant LR-MIS protein (PRV-100), were published in the Proceedings of the National Academy of Sciences. The proof of concept study conducted in mice showed efficacy in protecting the ovarian reserve against the gonadotoxic insults of three commonly used chemotherapeutics: Doxorubicin, Carboplatin, and Cyclophosphamide.
In the study, PRV-100 administered using intraperitoneal osmotic pumps concurrently with two rounds of chemotherapy was effective in protecting the ovarian reserve following treatment with Cyclophosphamide, Carboplatin, and Doxorubicin as evidenced by primordial follicle counts 20%, 40%, and 190% higher than unprotected controls respectively. On the safety side, PRV-100 was well tolerated with no observable side effects, and the pharmacokinetics of the recombinant protein were found to be compatible with subcutaneous injections.
On the basis of these data, the company has designed prospective phase I-II studies to be conducted at the Massachusetts General Hospital, and sought pre-IND advice from the FDA. Subsequent efficacy studies will evaluate PRV-100 as single-agent therapy for use in pre-menopausal triple negative breast cancer patients receiving a chemotherapy regimen that includes Doxorubicin.
Per Provulis’ assessment, there were approximately 49,200 new cases of triple negative breast cancer diagnosed in the U.S. in 2016, of which 6000 were pre-menopausal. This indicates a significant market opportunity for PRV-100, if approved.