SYDNEY, June 28 (Bernama-GLOBE NEWSWIRE) -- George Clinical and EPS Corporation (EPS), a global CRO based in Japan are collaborating on a rare Japanese academia-led global study seeking to advance treatments for unmet needs in Asian populations. 

In 2019 George Clinical and EPS formed a strategic partnership to help expand their operations across the Asia-Pacific region. Together the organizations have partnered on over 20 studies, mainly in oncology, kidney, metabolic and cardiovascular diseases therapeutic areas. In this reciprocal strategic partnership, both companies come together to provide a seamless operating capability for clinical trials across the Asia-Pacific region and globally.

Since September 2019, EPS and George Clinical have been involved in a major study for the National Cancer Center Hospital, Japan (NCCH) on the clinical usefulness of a combination therapy in patients of any menopausal status with advanced or metastatic HR+/HER2- breast cancer. A major objective of NCCH for conducting this study (Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib +- Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer - PATHWAY) is to investigate a potential new treatment. The NCCH run PATHWAY trial is a clinical research collaboration with Pfizer Inc., a research funder and a study drug provider.  The study is especially important, as Japanese investigator/academia-led global clinical trials have rarely been conducted due to language barriers, personnel shortage or limited research budget.

In 2016, among all the Clinical Research Core Hospitals in Japan, NCCH was selected by AMED (Japan Agency for Medical Research and Development) as one of the Global Clinical Trials Core Centers, focused on the reinforcement of facilitating international clinical trials in Japan between 2016-2018. This study is their first global investigator-initiated registration-directed trial (IIRDT) -- an important step toward the pursuit of the development of treatments and new drugs for the Asian population.

EPS is managing the PATHWAY study conducted in Japan, South Korea, Singapore and Taiwan. George Clinical is entirely responsible for study execution in Singapore and Taiwan with specific duties including full study conduct, regulatory, safety reporting and site monitoring. George Clinical's strong expertise in regulatory, site knowledge and oncology expertise in the Asia Pacific region add value to the EPS strengths in Japan.

This PATHWAY study exemplifies the value of the strategic partnership of two highly experienced CROs who combine their services to ensure that a sponsor's study is conducted in the most efficient and effective manner to help bring new and advanced treatments to underserved populations. Both George Clinical and EPS have a proven track record of meeting a sponsor's needs with proactive solutions to challenges and on the ground knowledge of sites, local key opinion leaders and cultural nuances. This is especially valuable regarding the specific regulatory requirements in different locations with local language and cultural expertise.

This Phase III trial has met its primary endpoint of demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib plus tamoxifen compared with placebo plus tamoxifen in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. NCCH believes the results of this PATHWAY study have a high impact for premenopausal breast cancer patients, for which a large percentage of patients exist in Asia Pacific with fewer treatment options. Detailed efficacy and safety results were recently presented at the 2023 ASCO Annual Meeting.

Based on the experience and network gained from this trial, NCCH continues to expand the research network through the Asia Clinical Trials Network for Cancers Project (ATLAS project) with the mission to create a multinational cancer clinical trial network and a sound structure for conducting international collaborative trials on a permanent basis in the Asian region.

About George Clinical
George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With over 20 years of experience and more than 450 people managing over 39 geographical locations throughout the Asia-Pacific region, USA, and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.   

 About EPS Corporation
Since its establishment in 1991 as a pioneering CRO, EPS Group has been a Healthcare Solution Provider to pharmaceutical companies, medical device manufacturers, hospitals and clinics, and academia with various solutions from development to marketing, sales, consultation covering Asia and new values created in big data & AI, regenerative medicine, etc.  The strength of EPS lies in the fact that it has the greatest presence in Japan. In Asia, the company has multiple overseas offices and has focused particularly on solidifying its sites in the respective Asian countries, providing clinical development support services as well as SMO services.

Contact:            eps-gr-contact@eps.co.jp
Website:           https://www.epsi-global.com/index.html and https://www.eps.co.jp/en/
LinkedIn:           https://www.linkedin.com/company/eps.corp/


Matthew Reabold
George Clinical
760-645-0496
mreabold@georgeclinical.com 

SOURCE : George Clinical

--BERNAMA