Novogen reports phenoxodiol improves survival in gynecological cancer cases

New York, Oct. 24 - Novogen Ltd. said two clinical studies found its experimental drug phenoxodiol extended life for women with late-stage ovarian cancer and in women with early stage cancer of the cervix and vagina.

"A response with improved survival in this type of patients demonstrates the uniqueness of this new drug when combined with standard drug therapies," said Mor, a researcher at Yale University's School of Medicine, in a news release.

"We are confident that these results indicate that phenoxodiol demonstrates a promising new opportunity in the management of these serious cancers experienced by many women."

Mor presented data from the two clinical studies at the International Menopause Society Meeting in Buenos Aires on Saturday.

The ovarian cancer study involved 43 patients whose cancer had failed to respond to all available therapies and were regarded as being resistant or refractory to the standard first-line therapies of a platinum (cisplatin or carboplatin) and/or a taxane (paclitaxel). A primary purpose of the study was to test the ability of phenoxodiol to reverse drug resistance to cisplatin or paclitaxel, thereby restoring the ability of the cancers to respond to these potent anti-cancer drugs.

Mor's interim data showed survival was "substantially extended" after combining phenoxodiol with either paclitaxel or cisplatin. The median survival with phenoxodiol plus cisplatin was 62 weeks and with phenoxodiol plus paclitaxel 48 weeks. At 75 weeks 35% of patients being treated with phenoxodiol plus paclitaxel were still alive, and at 72 weeks 35% of patients taking phenoxodiol plus cisplatin were still alive. This compares with median survival reported for patients on standard therapy of only 28 to 40 weeks, Novogen said.

In the second trial, women with cervical cancer were treated with phenoxodiol alone as a first-line therapy for recently diagnosed squamous cell carcinomas of the cervix, vagina or vulva. These cancers typically show very poor response to chemotherapy and normally are managed with surgery and radiotherapy.

In Mor's preliminary data for 13 patients randomized to two oral dose levels of 50 and 200 mg phenoxodiol given as a monotherapy, 29% showed regression or stabilization of tumors over a four-week period of treatment.

There were no phenoxodiol-related adverse events or side effects reported in either study.

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 phenoxodiol to market globally from its parent company Novogen. (ASX: Novogen - Nasdaq: NVGN). Novogen is a North Ryde, New South Wales, Australia, company developing therapeutics in oncology, cardiovascular disease and inflammatory diseases based on its phenolic drug technology.

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