Intravenous Phenoxodiol-cisplatin combination well tolerated in platinum resistant ovarian cancer

Mar 21 2011

Marshall Edwards, Inc.(Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from a Phase II clinical trial of intravenous Phenoxodiol in combination with cisplatin in women with platinum-resistant ovarian cancer. The publication is now available on the International Journal of Gynecological Cancer website and scheduled to print in the May issue of the journal.

The study, conducted at Yale-New Haven Hospital, showed that the combination of intravenous Phenoxodiol, a novel NADH oxidase inhibitor, with cisplatin, a platinum-based chemotherapy, was well tolerated and resulted in an overall response rate of 19% (3 out of 16) among ovarian cancer patients previously resistant to platinum. Response rate in this study was defined as the percentage of patients whose tumor demonstrated a radiologically confirmed reduction or disappearance after treatment. An abstract can be found at www.marshalledwardsinc.com/our-programs/scientific-publications that describes more information on the trial results.

"These results suggest that the combination of intravenous Phenoxodiol with cisplatin has a good safety profile and may be capable of reversing resistance to platinum-based chemotherapy," said lead author Michael G. Kelly, MD, a gynecologic oncologist at Tufts Medical Center and former fellow at Yale University School of Medicine." This study provides early clinical proof-of-concept for the combination of NADH oxidase inhibitors with standard-of-care chemotherapy and lays the groundwork for the development of more potent next-generation compounds."

To date, Phenoxodiol, an investigational drug, has been introduced into more than 400 patients in multiple clinical trials via oral or intravenous routes and has been well tolerated. Marshall Edwards has identified a next-generation compound called NV-143 that in laboratory studies has demonstrated significantly more activity than Phenoxodiol against a broad range of tumor cell lines. In addition to being more active as a single agent, NV-143 appears to be superior in its ability to synergize with platinum-based chemotherapy in pre-clinical studies. As a result, the Company plans to initiate a Phase I clinical trial of intravenous NV-143 later this year, followed immediately thereafter by randomized Phase II trials in combination with chemotherapy.

"These published results combined with data from previous studies reinforce our conclusion that intravenous administration is the optimal route of delivery for this class of drugs and give us added confidence moving forward as we develop our next-generation compound NV-143 for the clinic," said Robert D. Mass, MD, Acting Chief Medical Officer of Marshall Edwards.