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Marshall Edwards Licenses the Investigational Anti-Cancer Compound NV-128 From Novogen Limited
Wednesday, August 05, 2009 8:05 AM


NEW CANAAN, CT and SYDNEY, AUSTRALIA -- (Marketwire) -- 08/05/09 -- Novogen Limited (ASX: NRT) (NASDAQ: NVGN) and Marshall Edwards, Inc. (NASDAQ: MSHL) have concluded a license agreement for Marshall Edwards to develop and commercialize the oncology compound NV-128.

NV-128 is a cancer compound which has been shown in pre-clinical studies to promote cancer cell death in multi-drug resistant cancer cells by inducing caspase-independent DNA degradation and cancer cell death via the AKT-mTOR pathway.

The terms of the license consist of a single upfront payment to Novogen of US$1.5million, a series of payments for reaching the milestones of US Investigational New Drug (IND) approval, entering human testing at phases II and III and receipt of a New Drug Application for marketing and a royalty on sales of five per cent. Marshall Edwards will fund the ongoing clinical programs and is responsible for the commercial development of the drug.

Marshall Edwards is also the licensee of the Novogen developed investigational anti-cancer drugs phenoxodiol and triphendiol that are currently in clinical development. The Company has concluded recruitment in the phase III Ovature trial for phenoxodiol in chemotherapy resistant ovarian cancer, and has received approval from the US FDA to trial triphendiol in clinical studies in the US for pancreatic cancer and cholangiocarcinoma. Triphendiol also has orphan drug status from the FDA for these indications and late stage melanoma.

The Chairman of Marshall Edwards, Professor Bryan Williams, said the in-licensing of the mTOR inhibitor NV-128 is an exciting extension to the MSHL portfolio. Each of the drugs in the company portfolio has the benefit of preclinical activity against hard to treat cancers and an expected safety profile that makes their potential as effective anti-cancer agents highly promising.

"NV-128 has a different mode of action to our current drug candidates and its advantages over other mTOR inhibitors auger well for an exciting and valuable addition to the pharmaceutical armamentarium of new cancer treatments."

About NV-128

NV-128 does not rely on the traditional approach of caspase-mediated apoptosis, a death mechanism which is not effective in cancer cells that have become resistant to chemotherapy. Rather, NV-128 uncouples a signal transduction cascade which has a key role in driving protein translation and uncontrolled cancer cell proliferation. Further, NV-128 induces mitochondrial depolarization via the novel mTOR pathway. In cancer cells, mTOR signals enhance tumor growth and may be associated with resistance to conventional therapies. Inhibition of the mTOR pathway appears to shut down many of these survival pathways, including proteins that protect the mitochondria of cancer cells.



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