TAIPEI, Feb. 10, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") announced today the acceptance of an abstract for presentation at the prestigious American Society of Clinical Oncology, Genitourinary (ASCO-GU) Cancers Symposium conference, which will be held at the Moscone Convention Center West in San Francisco, CA, from February 13 to 15, 2025.
The abstract is titled: "Global, Phase 3, Open-Label, Single-Arm Studies to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) and FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients with Advanced Prostate Cancer (KATANA studies).", and highlights our commitment to improve advanced prostate cancer treatment. Building on the success of CAMCEVI® and our SIF-LAI technology, the KATANA studies will help evaluate the efficacy and safety of FP-014 11.25 mg every 3 months and 22.5 mg, every 6-months injections which have the potential to provide significant benefits for patients with advanced prostate cancer, with its unique and differentiated profile offer substantial benefits for an opportunity to become the only available ready-to-use triptorelin long-acting injectable ("LAI").
Poster Board Number: M3
Abstract Number: TPS284
Session Title: Trials in Progress Poster Session A: Prostate Cancer
Date and Time: Thursday, February 13, 2025, from 11:25 AM-12:45 PM PT
Location: Level 1, West Hall
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"This prestigious event brings together leading urology, oncology, and cancer research experts to discuss the latest advancements and findings related to prostate cancer," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "The accepted abstract presents our differentiated FP-014 Phase 3 clinical program and highlights our broad efforts in developing new treatment modalities and differentiated treatments for prostate cancer patients, contributing to the ongoing dialogue surrounding prostate cancer care and research," added Dr. Lee.
"This acceptance demonstrates the success of Foresee's pioneering SIF-LAI technology across several product types and indications, further highlighting the broad potential of this technology in developing best-in-class ready-to-use LAI's," said Dr. Yuhua Li, Chief Technology Officer at Foresee.
"It represents an important opportunity for our work to be recognized globally," said Dr. Ben Chien, Foresee's Chairman and CEO. "We are excited to initiate our studies later this year, as we see a remarkable opportunity to capture a significant share of the triptorelin market around the world in view of FP-014's best-in-class profile."
The abstract will become available on the Foresee website after the conference.
About
FP-014 (triptorelin)
FP-014 (triptorelin) is a ready-to-use, subcutaneous, long-acting injectable dosage form administered every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance.
Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of premenopausal breast cancer, precocious puberty, endometriosis, uterine fibroids, etc.
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 (LAI) 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, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Triptorelin (FP-014), aiming for the treatment of advanced prostate cancer, is ready to enter Phase 3 clinical studies, with respective trials planned for the 3-month and 6-month ready-to-use LAI formulations. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space.
SOURCE Foresee Pharmaceuticals Co., Ltd.
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