Green Cross receives BfArM approval for Phase ll trial of BST204

22nd December 2017 (Last Updated December 22nd, 2017 00:00)

South Korea-based company Green Cross Wellbeing has received approval from German regulatory authority Federal Institute for Drugs and Medical Devices (BfArM) to begin a Phase ll clinical trial of BST204 to treat patients with cancer-induced muscle loss, known as cancer cachexia.

South Korea-based company Green Cross Wellbeing has received approval from German regulatory authority Federal Institute for Drugs and Medical Devices (BfArM) to begin a Phase ll clinical trial of BST204 to treat patients with cancer-induced muscle loss, known as cancer cachexia.

The approval was granted to a clinical trial application (CTA) submitted by Green Cross Wellbeing to BfArM.

The trial is scheduled to begin by the end of the first quarter of next year, and expects to enrol around 150 patients with solid tumour malignancies, including colorectal and lung cancers at various sites in Germany.

It will evaluate the safety and efficacy of BST204 along with the goal of proof-of-concept (POC) in cancer cachexia patients with increased muscle strength and lean body mass.

Green Cross Wellbeing CEO Young-hyo Yoo said: “Cancer cachexia is directly responsible for at least 20% of all cancer deaths.

"BST204 represents a promising new approach to fill an important unmet medical need."

“Our ultimate goal is to make a meaningful difference in the lives of patients with this devastating condition. BST204 represents a promising new approach to fill an important unmet medical need.”

In addition, cancer cachexia is estimated to occur in around 50% of cancer patients and could cause the loss of protein stores, severe weakness and fatigue, immobility, as well as the tolerance and response to cancer treatments.

No drugs are currently approved for use in the treatment of the disease.

Green Cross’ BST204 drug candidate has been derived from ginseng, Panax ginseng CA Meyer.

Ginseng previously demonstrated its ability to increase appetite, facilitate physical function and boost immune function.

BST204 was also found to increase physical activity and reduce bone marrow toxicity in xenografted mice treated with chemotherapy, including 5-FU, cisplatin, and doxorubicin.