Privately-owned Foresee Pharmaceuticals has announced top-line results from a Phase III study of its investigational prostate cancer drug FP-001 LMIS (leuprolide mesylate injectable suspension).
The primary efficacy end point of the trial was the suppression of serum testosterone according to certain parameters. This was reportedly achieved in 97% of the 137 subjects enrolled in the study.
The Taiwanese firm has a proprietary drug delivery platform it says will enable rapid development of new formulations of marketed drugs that offer significant product differentiation, targeting the same indications or new indications.
Overall, treatment with LMIS 50mg injection every six months was reported to be safe and well tolerated, with safety data similar to those of marketed LH-RH agonists in the same patient population.
Chief executive Ben Chien stated: “Our Stabilized Injectable Formulation platform technology overcomes the technical barriers that our competitors have had over the years in generating a stable, premixed, prefilled version of leuprolide depot for injection.”
“We are confident that FP-001 LMIS will successfully penetrate the fast growing global prostate cancer market of $7.5 billion via key strategic collaborations such as a commercial partnership in the USA and out-licensing in other key territories such as Europe, Japan, China, and emerging markets.”