WASHINGTON, June 17 /PRNewswire-FirstCall/
-- Marshall Edwards Inc. (LSE-AIM: MSH), subsidiary of Novogen Limited (Nasdaq:
NVGN
- News), announced today
that an Investigational New Drug application (IND) has been cleared by the
U.S. Food and Drug Administration (FDA) for the start of a phase II clinical
trial of phenoxodiol, administered orally, to women with squamous cell carcinoma
(SCC) of the cervix, vagina and vulva.
Marshall Edwards
Inc. is commissioning researchers from the Yale University School of Medicine
to commence a human trial for the treatment of these cancers using phenoxodiol
in oral dose form.
Cancers of
the cervix, vagina and vulva are mostly of the type known as squamous cell
carcinoma (SCC) and are recognized for their poor response to standard chemotherapy.
Surgery remains the treatment of choice for these cancers in women, and treatment
in advanced cases is associated with low survival rates. The need for an effective
and well-tolerated chemotherapy is urgent.
SCC is a common
type of cancer found in the skin and mucous membranes of the body. In addition
to its involvement in skin cancer, it also is the most common cancer of the
mouth, tongue, throat, and the reproductive organs. The potential for phenoxodiol
in the treatment of SCC arose from an observation that patients being treated
with phenoxodiol for other forms of cancer, who coincidentally had SCC of
the skin, had experienced significant tumor regression. This prompted the
establishment of a phase II study for the treatment of cutaneous SCC (in
progress at a major teaching hospital in Sydney) and suggested the possibility
that other forms of SCC might be suitable targets for phenoxodiol.
Phenoxodiol
is an 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.
Under an earlier
IND approval obtained in 2001 from the FDA, the researchers at Yale, who
are to conduct the oral phenoxodiol human trial, are already conducting a
phase II study of phenoxodiol in intravenous dose form for the treatment of
advanced stage ovarian cancer and have reported promising results with no
drug-related side effects.
Executive
Chairman of Marshall Edwards Inc., Dr. Graham Kelly said, "The Yale University
experience with the use of phenoxodiol in reproductive cancers in women makes
it well placed to pursue phenoxodiol in treatment of SCC. The Yale team had
previously identified that phenoxodiol represents a breakthrough in anti-cancer
therapeutics by targeting death receptors in cancer cells, with no effect
on these receptors in normal cells."
"Inactivation
of these receptors has been identified as a major reason why ovarian cancers
can survive and resist chemotherapy. Phenoxodiol works by reactivating these
receptors, thereby allowing the body's immune system to kill the cancer cells,"
Dr. Kelly said.
"It is interesting
that inactivation of the death receptor mechanism has been identified as a
major reason for the resistance of SCC to chemotherapy. This could account
for the apparent high sensitivity of this tumor type to phenoxodiol," Dr.
Kelly added.
The Yale team
had previously reported that phenoxodiol produces dramatic reductions in
the size of human ovarian cancer tumors in animals. Clinical studies at Yale
have further demonstrated that disease stabilization had been realized in
ovarian cancer patients.
"In the Yale
laboratories, we could not find another compound as promising as phenoxodiol
for ovarian cancer," said Professor Thomas Rutherford MD of the Department
of Obstetrics and Gynecology at Yale University School of Medicine. "In some
of the women in the ovarian cancer trial, disease stabilization has been realized.
We look forward to seeing how the compound will work in SCC patients."
In other studies,
phenoxodiol currently is being evaluated in Phase II trials in patients with
prostate cancer, ovarian cancer, and cutaneous squamous cell carcinoma.
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.
The oncology
compound phenoxodiol is being developed by Marshall Edwards Inc., the listed
subsidiary of Novogen Limited. 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 utilizing the
expertise and clinical research capabilities of universities and hospitals
in the U.S., Australia and other key international locations.
More information
on phenoxodiol and on the Company can be found at www.marshalledwardsInc.com and
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:
Prof. Alan Husband, Group Information Vice President Research, of Marshall
Edwards Inc., +011-61-2-8877-6196, or David Sheon, USA, +1-202-518-6384, for
Marshall Edwards Inc.