Pharmaceutical Business review

FDA approves Marshall Edward ME-143 IND

The preclinical study results demonstrated that ME-143 showed anti-tumor activity against tumor cell lines, including breast, colorectal and ovarian.

Additionally, ME-143 has also shown an ability to enhance the cytotoxic effects of chemotherapy in pre-clinical studies.

The company intends to start a Phase 1 trial of intravenous ME-143 by September 2011.

Marshall Edwards president and CEO Daniel Gold said they are excited to get back into the clinic and are working diligently to initiate a Phase I trial of ME-143 as soon as possible.