Novogen Limited through its associated company Marshall Edwards Inc has commissioned a phase II clinical study of its novel anti- cancer drug, phenoxodiol, on skin cancer patients.
The trial is being conducted at Royal North Shore Hospital, Sydney, Australia, under the supervision of dermatologist, Professor Alan Cooper and medical oncologist, Dr. Helen Wheeler.
The objective of the study is to test the anti-tumor effectiveness and the safety of low doses of phenoxodiol administered orally to patients with Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, the two most common forms of skin cancer. Other Squamous Cell tumors include cancer of the cervix, mouth and lung.
Phenoxodiol is an Australian-developed anti-cancer drug that belongs to a new generation of drugs known as signal transduction inhibitors. These drugs work by inducing programmed cell death in cancer cells (apoptosis), with little or no effect on normal cells.
Professor Cooper said his interest in conducting a clinical trial on phenoxodiol stemmed from a pilot study that suggested the drug might be able to target many different types of human cancers.
The Royal North Shore study followed the presentation of data on phenoxodiol by Yale University researchers last week at the Society for Gynecologic Investigation, Washington D.C., as well as the publication of data on phenoxodiol in the proceedings of the American Association for Cancer Research annual meeting.
The Yale report demonstrated how the drug worked and noted that disease regression or stabilization had been realized in some ovarian cancer patients.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials. After the results of these trials are submitted in a new drug application to the FDA, the FDA must approve the drug as safe and effective before marketing can take place.