Foresee Pharmaceuticals Co., Ltd. announced on the 1st that the company's FP-001 (also known as Camcevi) Phase III clinical trial for pediatric central precocious puberty, known as The Casppian Study, has received a positive safety review recommendation from the Data and Safety Monitoring Board (DSMB). The DSMB recommended the company to proceed with the clinical plan adjustments.
Foresee Pharmaceuticals Biotech stated that the Casppian Phase III clinical trial is an open-label, multinational, multicenter trial designed to evaluate the efficacy, safety, and pharmacokinetics of leuprorelin 42 mg (FP-001 six-month formulation) long-acting injection in patients with central precocious puberty (GnRH-dependent). Foresee Pharmaceuticals Biotech's leuprorelin injection suspension (marketed under the CAMCEVI brand name) has already been approved for the treatment of advanced prostate cancer in adult patients, demonstrating good efficacy and safety results with statistical significance.
Dr. Bassem Elmankabadi, Senior Vice President of Clinical Development at Foresee Pharmaceuticals, expressed his delight at receiving the DSMB's positive recommendation to continue the clinical trial. Ensuring the safety of children participating in the trial is of utmost importance, and we will continue to uphold the highest standards of safety and ethical conduct throughout the entire clinical trial process. The trial is expected to yield results by 2025.
Foresee Pharmaceuticals's founder and chairman, Jian Ming-da, stated that Foresee Pharmaceuticals's FP-001 42 mg (subcutaneous injection every six months) has the potential to become the only pre-filled, ready-to-use leuprolide six-month long-acting injection without the need for mixing, providing benefits to the CPP patient community. The positive recommendation from the DSMB brings us closer to our goal of providing safe and effective treatment to children in need, and we look forward to seeking collaborative sales partners in the CPP field as we move towards commercialization.
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