STAMFORD, Conn., April 7 /PRNewswire-FirstCall/ -- Pharmaceutical company,
Novogen Limited, (Nasdaq: NVGN) 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.
"We have sufficient positive anecdotal evidence of anti-tumor activity for
phenoxodiol on skin cancers to warrant a formal investigation of this drug,"
Professor Cooper said. "Especially encouraging is phenoxodiol's apparent
absence of toxicity in treating patients whose general health and well being
is already severely compromised."
Professor Cooper said a total of 30 patients would be recruited with each
patient taking phenoxodiol for up to 12 weeks.
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.
Novogen is a world leader in the research and development of drugs derived
from its phenolic technology platform. The company manages its international
research and development programs utilising the expertise and clinical
research capabilities of universities and hospitals in the U.S., Australia and
other key international locations. The oncology compound phenoxodiol is being
developed by the Company's listed subsidiary Marshall Edwards Inc.
(LSE-AIM: MSH).
More information on phenoxodiol and on the Company can be found at
http://www.marshalledwardsinc.com and http://www.novogen.com.
Statements herein that are not descriptions of historical facts are
forward-looking and subject to risk and uncertainties. Actual results could
differ materially from those currently anticipated due to a number of factors,
including those set forth in the Company's Securities and Exchange Commission
filings under "Risk Factors," including risks relating to the early stage of
products under development; uncertainties relating to clinical trials;
dependence on third parties; future capital needs; and risks relating to the
commercialization, if any, of the Company's proposed products (such as
marketing, safety, regulatory, patent, product liability, supply, competition
and other risks).
CONTACT: Warren Lancaster of Novogen Limited, +1-203-327-1188, ext. 15;
or David Sheon, +1-202-518-6321, for Novogen Limited.
SOURCE Novogen Limited
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Related links:
http://www.novogen.com
http://www.marshalledwardsinc.com
CONTACT:
Warren Lancaster of Novogen Limited,
+1-203-327-1188, ext. 15; or David Sheon, +1-202-518-6321, for
Novogen Limited
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