FP-001：Prostate Cancer; Central Precocious Puberty
In an aging society, the number of prostate cancer patients is on the rise. According to GLOBAOCAN, approximately 10 million new cancer cases in men worldwide in 2020, prostate cancer accounts for 14.1% of new cases. In the United States, 1 in every 8 men would likely be diagnosed with prostate cancer. According to GLOBAOCAN, in the United States, 209,512 patients were diagnosed with prostate cancer in 2020, accounts for 17.1% of new cancer cases; prostate cancer is among the most common cancers diagnosed in males. Hormonal therapy is the standard palliative treatment in men with advanced prostate cancer. Long-acting gonadotropin releasing hormone (GnRH) agonists have greatly contributed to physician use of and patient compliance with this therapy.
However, the current commercially available depot products must be supplied in complicated dosage forms, i.e., microparticles and double syringe packages separating active ingredient from carriers. Reconsititution or mixing immediately prior to administration is required, which is not user friendly and may result in inaccurate doses. Needle clogging has been frequently encountered in some cases with microparticles. CAMCEVI is designed to overcome the drawbacks of the commercial depot products containing GnRH agonists. The SIF sustained-release drug delivery technology can significantly improve the stability of the drug delivery system using suitable excipients. The enhanced stability allows the formulation, such as CAMCEVI, to be pre-filled in an injection syringe, to have a satisfactory shelf life, to waive mixing prior to use, and to be free from occlusion in needle, all of which ease the injection for patients.
The multi-national, multi-center Phase III clinical trial for CAMCEVI 42 mg (LMIS 50 mg, 6-month formulation) was completed in October 2016. The results of the global multi-national multi-center Phase III clinical trial were announced in January 2017 and 97% of the subjects achieved primary efficacy endpoint. NDA approval has been granted from the U.S. FDA in May 2021, the approval of NDS in Canada has been granted in November 2021, and the EMA approval has been received in May 2022. CAMCEVI 42 mg was officially launched in the U.S. in April 2022. The multi-national, multi-center Phase III clinical trial for CAMCEVI 21 mg (LMIS 25 mg, 3-month formulation) was completed and the results of the global multi-national multi-center Phase III clinical trial were announced in February 2019 and 97.9% of the subjects achieved primary efficacy endpoint. The preparation for regulatory approval applications for CAMCEVI 21 mg is currently undergoing.
Central precocious puberty
Central precocious puberty 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 central precocious puberty 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. Puberty may occur even before three years of age in some cases of this disorder. Because of the early growth spurt, children with central precocious puberty may be taller than their peers; however, they may stop growing abnormally early. Developing ahead of their peers can be emotionally difficult for affected individuals and may lead to psychological and behavioral problems.
According to NORD（National Organization for Rare Disorders）website, CPP occurs in 1 out of 5,000 to 10,000 children. It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female to male ratio of around 20 : 1; clinical research is beginning to identify rare genetic causes for some of these cases. For instance, activating mutations of the kisspeptin gene (KISS1) and its receptor (KISS1R), which are known for their stimulatory effect on the hypothalamus ultimately leading to increased gonadotropin secretion, have been identified as precipitating precocious puberty.
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 followed by prostate cancer is planned for the treatment of central precocious puberty (CPP) in children.
Foresee has submitted a phase 3 IND application to the US FDA in July 2022 and may proceed with FP-001 42 mg phase 3 clinical trial in patients with central precocious puberty from August 19, 2022. The clinical trial is being initiated currently. For detailed study design, please visit：
https://clinicaltrials.gov/ct2/show/NCT05493709?term=Foresee+Pharmaceuticals&draw=2&rank=6 (Identifier: NCT05493709)。