July 27, 2011
, Inc.(Nasdaq: MSHL), 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
"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
, M.D., Department of Obstetrics, Gynecology, and Reproductive Sciences,
Yale University School of Medicine
. "This study shows that NV-128 can specifically target the mitochondriain 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
showed that NV-128 is able to inhibit tumor 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
to NV-344, its active metabolite, which has been shown to be significantly more potent than NV-128 in pre-clinical research studies.
plans to complete the required pre-clinical studies of NV-344 to submit an Investigational New Drug (IND) application to the U.S. 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
as well as our continuing commitment to enhancing our pipeline of novel drug candidates," said
Daniel P. Gold
, Ph.D., President and Chief Executive Officer of
. "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."
About Marshall Edwards
, Inc. (Nasdaq: MSHL) is a
-based oncology company focused on the clinical development of novel anti-cancer therapeutics. The Company's lead programs focus on two families of small molecules that result in the inhibition of tumor cell metabolism. The first and most advanced is a NADH oxidase inhibitor program that includes lead drug candidate NV-143. The second is a mitochondrial inhibitor program that includes lead candidate NV-344. The Company expects to initiate a Phase I clinical trial of intravenous NV-143 in
, followed by randomized Phase II trials in combination with chemotherapy. For more information, please visit
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.