Choroid Plexus Neoplasms

The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned. There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. TAIPEI, April 1, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the 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 with a minor amended protocol. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of Leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). 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. "We are pleased to receive the positive recommendation from the DSMB to continue our clinical trial. Ensuring the safety of the children participating in our trial is paramount and we continue to be dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial. The top-line results from this trial are anticipated in 2025.", said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development at Foresee Pharmaceuticals. "Foresee's Leuprolide 42 mg formulation (FP-001) dosed subcutaneously every 6 months, has the potential to become the only ready-to-use Leuprolide 6-month long-acting injection on the market, providing benefit to stakeholders in the CPP community. This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children in need," said Dr. Ben Chien, Foresee's Chairman and CEO. "We look forward to establishing commercial partnership soon for the potential future commercialization of FP-001, in CPP indication." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated too early, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the 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. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, and Taiwan and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are being prepared for CAMCEVI® 21 mg. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the Casppian phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma and COPD. FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and a Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.

Multicenter, multinational Phase 3 Casppian study will evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). 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. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. TAIPEI, Oct. 13, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces that the first patient has been dosed in the Casppian Phase 3 registration study. Continue Reading "The Casppian Phase 3 study is an open-label, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin- Dependent) precocious puberty (CPP). The study duration is 48 weeks. The study's Primary endpoint is the percentage of patients with serum LH concentration < 4 mIU/mL 30 minutes following a GnRH agonist stimulation test at Week 24. Leuprolide (FP-001) 42 mg will be considered effective for the treatment of children with CPP if ≥ 80% of patients exhibit LH suppression < 4 mIU/mL at Week 24. The Casppian study will also test key secondary endpoints like the changes in bone ages, growth rate, and physical signs of puberty assessed by Tanner stages from baseline to the end of the study at 48 weeks, which the FDA has accepted," said Bassem Elmankabadi, M.D., Senior Vice President Clinical Development at Foresee Pharmaceuticals. "GnRH agonists, including leuprolide, are the standard of care for CPP patients. Foresee's FP-001, 42 mg subcutaneously every 6 months, has the potential to become the only six-month, ready-to-use leuprolide, providing benefit to multiple stakeholders in the CPP community." said Dr. Ben Chien, Foresee's Chairman, and CEO. "It is exciting to be expanding the therapeutic and commercial potential of FP-001 with the initiation of the Casppian study, and we look forward to establishing a commercial partnership for the potential future commercialization of FP-001, specifically in CPP." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated prematurely, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the 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. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU and Taiwan and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. The U.S. regulatory submission is anticipated in 2024. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the Casppian phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and a Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.

TAIPEI, July 25, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced today that the company has been selected for a late-breaking oral presentation on the positive primary outcomes of its aderamastat (FP-025) Phase 2 proof-of-concept allergic asthma study at the European Respiratory Society (ERS) International Congress 2023 taking place in Milan, Italy from September 9-13, 2023. The oral presentation entitled: "Effect of MMP-12 inhibitor, aderamastat (FP-025), on allergen-induced late response in asthmatic subjects" is the result of a collaboration with clinical experts in the area of asthma and pulmonology in the Netherlands, and focuses on the primary results from the assessment of the efficacy of multiple oral doses of aderamastat in HDM-allergic asthma patients. Oral Presentation Session: Pathways and mechanisms governing the pathogenesis of asthma and chronic obstructive pulmonary disease Monday September 11, 2023 Time: 9:30 am CET Location: Allianz MiCo, Milan Room: Brown 1+2 () "We are very excited to have the opportunity to present promising data related to the previously announced aderamastat topline Phase 2 proof-of-concept study. The data strongly support the role of MMP-12 in key inflammatory pathways that contribute to asthma and other lung diseases," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "With this Phase 2 study, our objective was to demonstrate that the inhibition of MMP-12 in humans was in line with the MMP-12 single-nucleotide polymorphism (SNP) data, human expression data, and animal pharmacology models. We could not be more confident with the role and importance of MMP-12 in immune-fibrotic diseases, particularly in the lung," added Dr. Lee. "With this recent positive aderamastat Phase 2 study, we are excited to shine a light on a novel therapeutic mechanism and are working diligently to build a broad first-in-class/best-in-class franchise leveraging aderamastat, our additional MMP-12 inhibitors, including FP-020, across several therapeutic areas," said Dr. Ben Chien, Chairman and CEO at Foresee. The presentation will be available on the Foresee website after the conference. About Aderamastat and MMP-12 Aderamastat is a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. Aderamastat showed sustained anti-inflammatory effects and attenuated allergen-induced histopathology in a mouse model of house dust-mite (HDM). Importantly, a Phase 2 allergen challenge asthma proof-of-concept study has been successfully completed. The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and becoming increasingly recognized as a key marker of inflammatory exacerbations and fibrosis. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) long-acting injectable technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, and EU and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. The U.S. regulatory submission is anticipated in 2024. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients. The study has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 Fanconi Anemia study is currently being initiated, and a P2 study in pulmonary hypertension group 3 patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.