Novogen says Yale study supports phenoxodiol in managing gynecological cancer

By Ted A. Knutson

Washington, Nov. 17 - Novogen Ltd. said a Yale University of Medicine study indicates continuing confidence that the experimental drug phenoxodiol has the potential to change management options for early stage cancer of the cervix and vagina.

Researchers from Yale presented the report at the International Conference on Molecular Targets and Cancer Therapeutics sponsored by the American Association of Cancer Researchers, the National Cancer Institute, and the European Organization for Research and Treatment of Cancer. The researchers giving the presentation were Drs. Masoud Azodi, Peter Schwartz, Michael Kelly, Thomas Rutherford and Gil Mor.

"We are confident that these results indicate that phenoxodiol demonstrates a promising new opportunity in the management of this serious cancer experienced by many women," Mor said in a company news release.

The study has so far recruited 16 women with squamous cell carcinoma of the cervix, vagina or vulva.

Phenoxodiol was administered eight-hourly for 21 to 28 days between their first diagnosis and surgical resection, the current first line strategy to manage this disease.

To date 14 patients have been evaluated, of whom six received 50 mg phenoxodiol per dose and eight received 200 mg per dose.

The tumor responses were assessed for change in size by the Recist method.

For those patients receiving the 50 mg dose, five of six patients had stable disease at the time of surgical resection whereas in the 200 mg dose group all eight patients had stable disease at the time of resection.

Analysis of the resected tumor specimens indicated that the drug was concentrated in tumor tissues in levels which were greater than the levels in the blood of these patients and further that the drug was converted to a more active form by deconjugation within the tumor. The researchers observed that cervical cancer tissue may contain the necessary deconjugating enzymes (glucuronidase, sulfatase) that convert the conjugated form of the drug (the principal form of the drug in the blood) to the bio-active free form, and that the free form of phenoxodiol then accumulates in the tumor tissue. This suggests phenoxodiol is uniquely suited to treatment of this type of cancer.

No toxicity was observed in any patients even in the 200 mg dose stratum, indicating the high safety profile of the drug, according to the research.

"The 28-day period of treatment in this study is a relatively short time to expect to see a change in tumor progression in these patients," Kelly said in the news release. "These data with cervical cancer provide evidence that orally administered phenoxodiol has a significant anti-tumor effect, particularly in the case of squamous cell carcinomas, which are relatively insensitive to standard anti-cancer drugs."

Phenoxodiol targets the plasma membrane sphingomyelin pathway, inhibiting the production of the pro-survival secondary messenger, sphingosine-1-phosphate (S-1-P), and in turn preventing the phosphorylation of the Akt signalling cascade and the formation of anti-apoptotic proteins.

Marshall Edwards, Inc. has licensed rights to bring phenoxodiol to market globally from its parent company, Novogen, a North Ryde, Australia-based biotech company.

The announcement was made in a 6-K filing with the Securities & Exchange Commission.

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