Marshall Edwards, Inc. an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced the publication of results from a pre-clinical study of NV-128 showing activity in chemotherapy-resistant ovarian cancer stem cells. NV-128 is the prodrug of the Company’s investigational compound and lead mitochondrial inhibitor drug candidate, NV-344.

The publication, entitled “Targeting the mitochondria activates two independent cell death pathways in the ovarian cancer stem cells,” is available on the Molecular Cancer Therapeutics website and scheduled to print in the August issue of the journal. An abstract can be found at www.marshalledwardsinc.com/our-programs/scientific-publications.

“A major obstacle in the successful treatment of ovarian cancer is disease recurrence due in part to the outgrowth of chemotherapy-resistant ovarian cancer stem cells,” said senior author Gil Mor, MD, Department of Obstetrics, Gynaecology, and Reproductive Sciences, Yale University School of Medicine. “This study shows that NV-128 can specifically target the mitochondria in patient-derived ovarian cancer stem cells to induce cell death in an otherwise chemo-resistant cell population. We believe these encouraging data provide sufficient proof of concept to warrant further study in ovarian cancer patients.”

Previous studies conducted at Yale University showed that NV-128 is able to inhibit tumour growth in an ovarian cancer animal model without inducing significant toxicity, suggesting a sufficient therapeutic window that may allow compounds of this class to be safely administered to patients. Once administered, NV-128 is demethylated in vivo to NV-344, its active metabolite, which has been shown to be significantly more potent than NV-128 in pre-clinical research studies. Marshall Edwards plans to complete the required pre-clinical studies of NV-344 to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) by the first quarter of 2012.

“This study exemplifies the importance of our ongoing collaboration with Dr Mor and his associates at Yale University as well as our continuing commitment to enhancing our pipeline of novel drug candidates,” said Daniel P Gold, PhD, president and chief executive officer of Marshall Edwards. “We are excited about the progress we are making with both of our lead candidates, NV-143 and NV-344, and look forward to reporting on their clinical development in the months ahead.”