CAMCEVI(FP-001):Prostate Cancer; Central Precocious Puberty

Prostate Cancer

As the population grows and gradually ages, prostate cancer patients have grown in number. According to GLOBAOCAN, prostate cancer is the second most common cancer in men globally. Approximately 10 million new cancer cases in men worldwide in 2020, prostate cancer accounts for 14.1% of new cases. Hormone therapy is the standard palliative treatment for advanced prostate cancer in males, with long-acting GnRH/LHRH agonists being widely used by physicians due to their ability to enhance patient compliance. CAMCEVI®, long-acting injections developed by Foresee are in formulations for 6 months (CAMCEVI® 42 mg) and 3 months (CAMCEVI® 21 mg), with the API being leuprolide mesylate, classified as a GnRH/LHRH agonist.

Designed and developed through Foresee's pioneering Stabilized Injectable Formulation technologies, CAMCEVI® is a differentiated ready-to-use long-acting depot injection, which overcomes the requirement of manual reconstitution – an obstacle that the already marketed leuprolide products face that can lead to handling inconvenience and potential risks of handing errors.

CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan and Israel and launched in the U.S. in April 2022.

The multi-national, multi-center Phase III clinical trial for CAMCEVI® 21 mg was completed and the results were announced in 2019. 97.9% of the subjects achieved primary efficacy endpoint. U.S. and EU regulatory submissions are being prepared.

Learn more about CAMCEVI® at: https://www.camcevihcp.com/


Central precocious puberty

Central precocious puberty (CPP) is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" was activated prematurely, causing children to enter puberty prematurely, between 2 years and 9 years of age.

While puberty normally starts between ages 8 and 13 in girls and between ages 9 and 14 in boys, patients with CPP begin exhibiting signs before puberty. The development of secondary sexual characteristics begins, such as girls developing breasts and beginning their menstrual periods; boys have growth of genitalia and deepening of the voice. According to NORD(National Organization for Rare Disorderswebsite, CPP occurs in 1 out of every 5,000 to 10,000 children. CPP is more common in girls than in boys, with a female to male ratio of around 20 : 1.

GnRH/LHRH agonists, in particularly the leuprolide depot injection, have been widely used for the treatment of CPP and are considered the standard of care. The second indication for CAMCEVI® 42 mg following advanced prostate cancer is planned for the treatment of CPP in children.

Currently, the multi-national multi-center Phase 3 clinical trial for FP-001 42 mg in patients with CPP (named Casppian study) is ongoing. For detailed study design, please visit:
https://clinicaltrials.gov/ct2/show/NCT05493709?term=Foresee+Pharmaceuticals&draw=2&rank=6 (Identifier: NCT05493709)。