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news.The US Food and Drug Administration (FDA) has approved Marshall Edwards' investigational new drug (IND) application of ME-143.
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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.