Navigation Links
Foresee Pharmaceuticals Announces Top-Line Results from Phase 3 Registration Study in Advanced Prostate Cancer
Date:1/26/2017

TAIPEI, Taiwan, Jan. 26, 2017 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), announced on Jan 16 the top-line result of FP-001 LMIS (Leuprolide Mesylate Injectable Suspension) 50mg phase 3 clinical trial, an open-label, single-arm study in subjects with Advanced Prostate Carcinoma. The primary efficacy end point was achieved in 97.0% of subjects. 

The primary efficacy end point is the percentage of subjects with suppression of serum testosterone (=50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The targeted efficacy was that the lower limit of the 2-sided 95% confidence interval (CI) for suppression is to be >90%. 

In this study, 137 subjects were enrolled and received a minimum of one dose of the study drug (ITT population), and 124 subjects completed the study without major protocol violations that would affect the primary efficacy endpoint (per-protocol population (PP)). The 95% CI from Kaplan-Meier estimates was (92.2%, 98.9%), and the 95% repeated-confidence interval was (92.5%, 99.4%). By day 28, mean testosterone concentration was suppressed below castrate levels to 17.6 ng/dL, and the suppression rate was 98.5% (135 out of 137 subjects achieved medical castration). No mean increase in testosterone was observed after the second injection. Four subjects did not achieve successful suppression of testosterone by the primary efficacy end point analysis, two of which failed to achieve castration level on day 28 and the other two had transient testosterone escapes. 

The most common adverse events reported in this study include "hot flushing" (48.9%), followed by "hypertension" (14.6%), "injection site pain" (7.3%), "fatigue" (6.6%), etc., most in mild or moderate intensity. Overall, treatment with LMIS 50 mg injection every 6 months was safe and well tolerated. These safety data are similar to those of marketed LH-RH agonists in the same patient population.

"We are excited about the successful top-line results of FP-001 LMIS, a program in which we have invested many years of internal R&D efforts." said Dr. Ben Chien, Chairman and CEO of Foresee, "Our Stabilized Injectable Formulation platform technology overcomes the technical barriers that our competitors have had over the years in generating a stable, premixed, prefilled version of leuprolide depot for injection. FP-001 offers prostate cancer patients a comfortable and convenient solution and facilitates the preparation and drug administration process for the healthcare specialists. Based on its differentiated profile, we are confident that FP-001 LMIS will successfully penetrate the fast growing global prostate cancer market of US$7.5B via key strategic collaborations such as a commercial partnership in the US and out-licensing in other key territories such as Europe, Japan, China, and emerging markets."

"In our first-in-class NCE pipelines, FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, is currently completing a Phase 1 study in Asthma/COPD, aiming to fulfill the huge unmet medical needs of US$36B estimated in 2019." said Dr. Ben Chien.   

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-top-line-results-from-phase-3-registration-study-in-advanced-prostate-cancer-300397962.html


'/>"/>
SOURCE Foresee Pharmaceuticals Co., Ltd.
Copyright©2017 PR Newswire.
All rights reserved


Related medicine technology :

1. C to C Collaborations Foreseen at the Global Economic Summit 2013
2. InDex Pharmaceuticals Will Participate in the European Crohns and Colitis Organisation (ECCO) Congress
3. Parallel Trade in Pharmaceuticals: Attendee list Released Ahead of 11th Annual Industry Summit
4. Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2016 Financial Results on February 15, 2017
5. Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating Defibrotide for the Potential Prevention of VOD in High Risk Patients
6. SHAREHOLDER ALERT: Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Anthera Pharmaceuticals, Inc. (ANTH)
7. Immune Pharmaceuticals Satellite Symposium at the International Symposium on Acute Leukemias XVI
8. Dr. Carsten Brunn to Lead Bayers Pharmaceuticals Business in the Americas Region
9. Research and Markets - Global Multiple Myeloma Drugs Market 2017-2021 with Amgen, Celgene, Johnson & Johnson, Novartis & Takeda Pharmaceuticals Dominating
10. Rigel Pharmaceuticals, Inc. Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
11. Cumberland Pharmaceuticals Announces Kenneth J. Krogulski To Join Its Board Of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/5/2017)... The Cincinnati location of ... (NYSE: DPLO), has been awarded a Top Workplaces 2017 ... Results are based on an employee survey administered by WorkplaceDynamics, ... improvement. The survey measures several aspects of workplace culture, including ... ...
(Date:6/3/2017)... June 3, 2017  Eli Lilly and Company ... results from the Phase 3 MONARCH 2 study ... 6 inhibitor, in combination with fulvestrant, significantly improved ... alone in women with hormone-receptor-positive (HR+), human epidermal ... who have relapsed or progressed after endocrine therapy ...
(Date:6/1/2017)... BELL, Pa. , June 1, 2017 ... (PRN) and Veterinarian Recommended Solutions (VRS), and KD Pharma ... investment in Nutriceutical Holdings by KD Pharma Group. KD ... Holdings with the option to acquire the entire company. ... partner in KD. They are committed to growing the ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Dr. ... New York, has recently begun offering three new minimally invasive procedures to patients ... procedures and reducing downtime, Dr. Rubinstein is excited to bring microneedling, microneedling facials, ...
(Date:6/23/2017)... ... June 23, 2017 , ... Goodcents Deli Fresh Subs today announced the opening ... 4210 SW 21st St. Topeka, Kan. 66604 (near 21st and Gage). It is owned ... owns three other locations in the Topeka and Bonner Springs, Kan. area. , ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... Breast Cancer Conference from Sept. 18 to 20. , The two-day conference is ... subtype with the goal of improving patients’ lives and eliminating racial breast cancer-related ...
(Date:6/23/2017)... ... June 23, 2017 , ... PureLife Dental is pleased to announce ... for CDA members. As part of the amalgam separator endorsement, all CDA members may ... than $400 off the retail value. This partnership between PureLife and CDA is especially ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ulster University, Magee Campus ... from 9 am to 3 pm to present to graduate students exciting new and ... an original curriculum project led by The Health Improvement Service of the Western Health ...
Breaking Medicine News(10 mins):