See, what did I tell you all - Novogen appears to have just about cured cancer - at least in Australia: <sigh>
Novogen takes major step in curing ovarian cancer
10/02/04 By: Andrew Nelson
Novogen Limited?s (NRT) American subsidiary, Marshall Edwards today announced that researchers from Yale University School of Medicine reported preliminary results of a dose-finding study in women with recurrent ovarian cancer using phenoxodiol. The substance is an investigational anti-cancer drug being developed by Marshall Edwards.
This early clinical testing supports the ability of phenoxodiol to act as both an anti-cancer agent in its own right and a chemo-sensitizing agent that restores responsiveness of ovarian cancer cells to standard chemotherapies. Phenoxodiol is an investigational drug and has not yet been approved for marketing in the US.
The data presented reflects the outcome from the first 20 of 40 measurable subjects at the first two doses tested. The purpose of the study was to evaluate the effect of certain doses of phenoxodiol on disease progression and tumor response in women with recurrent disease that has become unresponsive to standard chemotherapy.
According to the Yale researchers, of the 20 subjects who started the drug course, 13 were able to finish a three -month cycle and five of the 20 subjects (25%) were considered to have had disease stabilization.
All patients ultimately showed disease progression, but no toxicity was attributed to phenoxodiol at the two dosing levels reported at this time. Complete data from this study is not yet available according to the Yale researchers, and will be presented at a later date.
Although pre-clinical trials have indicated that phenoxodiol may well have the ability to stop ovarian cancer development in animals in its own right, the current tests are exploring the drugs use as a chemo-sensitizer for late-stage ovarian cancer.
The treatment aims to restore the sensitivity of the cancer cells to the cytotoxic action of standard chemotherapeutic drugs, in the expectation that that form of usage would deliver a greater anti-tumor effect in such advanced cases of cancer.
Principal investigator, Thomas Rutherford, M.D., associate professor of gynecology and reproductive sciences said that patients received phenoxodiol twice a week, which is how we believe it will be used in combinational therapy.
"We didn?t expect to see a major anti-tumor effect when used at this dose, so it is encouraging to see an apparent 25% stability rate in such unresponsive cancers."
"These results give us confidence in the potential use of phenoxodiol for the treatment of ovarian cancer," he said.
Pre-clinical studies in cells and in animals showed that phenoxodiol was able to induce in chemo?resistant ovarian cancer cells susceptibility to being killed by extremely low doses of standard drugs such as cisplatin and paclitaxel.
In an interim analysis of the entire study of 40 patients, where the Yale researchers focused on paclitaxel challenged patients, the researchers observed that eight of nine patients who were treated with paclitaxel following completion of the phenoxodiol trial showed a marked reduction in markers for ovarian cancer. Four of these patients had previously been defined as paclitaxel resistant.
Gil Mor MD, PhD, associate professor and a co-investigator in the study said that this is a preliminary finding only, but one that we find highly encouraging because it supports in humans what we saw in the laboratory; that phenoxodiol is a powerful chemo-sensitizer.
"Our experience is that few patients respond to follow-up therapy with taxanes once they have developed chemo-resistance, so to see this result is very encouraging," said Dr Mor.
Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc., said, we will be commencing a formal combinational study in ovarian cancer patients within the next couple of months.
"That will be the first time that we will have had the opportunity to use the drug the way that we believe it should be used."
"The current study has been useful in demonstrating the benefit of low doses of phenoxodiol, and we will be using the same low dose that has shown such promise in the current study," concluded Dr Kelly.
Novogen informed that ovarian cancer, the deadliest of the gynecologic cancers, currently kills 50% of the women diagnosed with it within five years. This is mostly due to the fact that the cancer ultimately develops resistance to standard anti-cancer therapies such as cisplatin and paclitaxel.
Marshall Edwards have licensed rights to bring phenoxodiol to market globally from its Australian parent company, Novogen Limited. Novogen develop a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases based on its phenolic drug technology platform.
Novogen was up 8c to $7.00 on yesterdays trades.
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