Green Cross Wellbeing Announces BfArM Authorisation to Initiate Phase 2 Study of BST204 for Cancer Cachexia
20 Dec, 2017
Company on Track to Initiate Study in First Quarter of 2018
Seongnam, South Korea, 20 December 2017 - Green Cross Wellbeing Corporation, a South Korean specialty pharmaceutical company, announced today that German regulatory authority, the Federal Institute for Drugs and Medical Devices (BfArM) has approved the company’s Clinical Trial Application (CTA) to advance BST204, a novel treatment for cancer cachexia, into a Phase 2 clinical trial in patient with cancer induced muscle loss, also known as cancer cachexia. Green Cross Wellbeing expects to initiate this study prior to the end of the first quarter 2018.
Cancer cachexia occurs in about 50 percent of cancer patients and may lead to loss of protein stores, severe weakness and fatigue, immobility, and an ability to tolerate and respond to cancer treatments. There are no drugs currently approved for the treatment of this condition.
BST204 is a botanical new drug candidate derived from ginseng, Panax ginseng CA Meyer. Ginseng is known to increase appetite, facilitate physical function and boost immune function. BST204 increased physical activity and decreased bone marrow toxicity in xenografted mice treated with chemotherapy such as 5-FU, cisplatin and doxorubicin.
In this Phase 2 trial, Green Cross Wellbeing plans to enrol approximately 150 patients with solid tumour malignancies, including colorectal cancer and lung cancer at multiple sites in Germany. The trial will assess the safety and efficacy of BST204, with goal of proof of concept (POC) in cancer cachexia patients with increased muscle strength and lean body mass.
“Cancer cachexia is directly responsible for at least 20 percent of all cancer deaths. Our ultimate goal is to make a meaningful difference in the lives of patients with this devastating condition,” said Young-hyo Yoo, Ph.D., Chief Executive Officer of Green Cross Wellbeing. “BST204 represents a promising new approach to fill an important unmet medical need.”
About Green Cross Wellbeing Corporation
Green Cross Wellbeing Corporation, a subsidiary of Green Cross Corporation (KRX: 006280), is a specialty pharmaceutical company based in South Korea. Green Cross Wellbeing has licensed, developed and marketed nutrition therapeutic products to improve patients’ lives.
This release includes forward-looking statements, which express the current beliefs and expectations of Green Cross Wellbeing’s management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.