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Foresee Pharmaceuticals Receives the Fourth Positive Recommendation from the DSMB to Continue the Casppian Ph3 Study, for Central Precocious Puberty (CPP)
Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the fourth positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial evaluating the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled-release in patie
About this update from Foresee Pharmaceuticals Co., Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the study as planned.","length":109,"tagName":"p"}]},{"val":[{"type":"text","content":"The Casppian study design included periodic evaluations and long-term safety monitoring for up to a total of 12 months following the first injection.","length":149,"tagName":"p"}]},{"val":[{"type":"text","content":"There has been no safety concern with the use of leuprolide (FP-001) injectable Emulsion in pediatric CPP patients.","length":115,"tagName":"p"}]},{"val":[{"type":"text","content":"The Casppian Phase 3 Study Met Primary Efficacy Endpoint, Demonstrating Robust LH Suppression with 6-Month Dosing Interval of leuprolide mesylate.","length":146,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":519,"olType":false},{"type":"text","content":"TAIPEI, Feb. 4, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the fourth positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial evaluating the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled-release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP).","length":619,"tagName":"p"},{"type":"text","content":"Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer.","length":342,"tagName":"p"},{"type":"text","content":""The unanimous safety endorsement from the independent board, following full enrollment in our Casppian Ph3 trial, is a powerful testament to the potential of our six-month treatment for children with CPP. Meeting the study's primary endpoint is a definitive signal that we are on the cusp of a potential therapy, bringing us closer to a future medicine where managing this condition is simpler and more effective fo...