Preliminary Results of Multi-Center Trial Indicate That 33 Percent of Late- Stage Refractory Ovarian Cancer Patients Experience
May 10 2005 - 10:07AM
PR Newswire (US)
Preliminary Results of Multi-Center Trial Indicate That 33 Percent
of Late- Stage Refractory Ovarian Cancer Patients Experience
Complete or Partial Responses on Combination Therapy That Includes
Phenoxodiol STAMFORD, Conn., May 10 /PRNewswire-FirstCall/ --
Marshall Edwards, Inc., today released preliminary results from a
Phase IIa trial in patients with ovarian cancer that has
demonstrated resistance to the standard first-line chemotherapies
of cisplatin and/or paclitaxel. In this trial, the investigational
drug phenoxodiol is being administered in conjunction with
cisplatin or paclitaxel in an attempt to reverse the acquired
resistance of the tumors to those two drugs. Phenoxodiol has not
been approved for marketing. The multi-center trial is being
conducted at the Yale - New Haven Hospital, New Haven, Conn., and
at the Royal Women's Hospital, Melbourne, Australia. Enrollment in
the current trial was limited to patients who demonstrated a high
level of chemo-resistance to either platinums (cisplatin or
carboplatin) or taxanes (paclitaxel, docetaxel). Patients were
either refractory, which is defined as disease progression while on
chemotherapy, or resistant, which is defined as having disease
progression within 6 months of receiving such chemotherapy. In
addition, patients were enrolled within an average 7 months of
completion of the last course of treatment with platinums or
taxanes, when chemo-resistance remains high. Twenty (20) subjects
received a combination of phenoxodiol + cisplatin and 20 patients
received phenoxodiol + paclitaxel. Eighty (80) percent of subjects
on combination therapy had either complete response (11 percent),
partial response (22 percent), or stabilized disease (44 percent),
providing an overall disease control rate of 77 percent. The
phenoxodiol and cisplatin or paclitaxel combinations were well
tolerated, with no unexpected toxicities encountered Dr. Graham
Kelly, Executive Chairman of Marshall Edwards, Inc., said, "The
generally-accepted clinical experience with the type of
chemo-resistant tumor that we have included in this study is that
they show very limited response to re-challenge with platinums and
taxanes. Objective tumor responses such as the complete and partial
responses that we have seen are very unusual, and these preliminary
results support the chemo-sensitizing potential of phenoxodiol."
"What gives us particular confidence to go forward into a
registration trial is the level of stringency that we have used in
our study. Most of the patients in our trial previously had shown
disease recurrence during chemotherapy, with the rest showing
disease recurrence within 6 months of therapy. Importantly, we also
took those patients within a relatively short time after disease
recurrence, meaning that we have selected a group of patients with
tumors that we can be confident would normally have a very low
level of sensitivity to platinums and taxanes," Dr Kelly added. The
current study has two parts. The first part, reported here,
involves enrolling subjects with the commonly-accepted definitions
of resistant or refractory disease. The second part, for which
subjects are currently being enrolled, involves taking the same
type of subjects as in the first part, but re-challenging them with
either carboplatin (10 subjects) or paclitaxel (10 subjects) and
then introducing phenoxodiol into their chemotherapy schedule only
when they show disease progression during therapy. The Company
believes this level of stringency marks the highest level of
challenge in chemo- sensitization yet tested. About the OVATURE
Study The OVATURE (OVArian TUmor REsponse) study is a Phase IIb/III
registration study that is proceeding in Australia and the U.K., as
a result of the evidence of the chemo-sensitizing effect of
phenoxodiol seen in the first part of the Phase IIa study, as well
as the results of the highly stringent second part of the study. In
the OVATURE study, patients with platinum-resistant ovarian,
fallopian tube or primary peritoneal cancer will be re-challenged
with weekly carboplatin and have phenoxodiol introduced into their
chemotherapy treatment schedule once they have shown disease
progression on weekly carboplatin. The study is being run at 5
sites in Australia, 4 in the UK, and the Company also intends to
seek approval to conduct the study at 8 sites in the United States.
For information on the OVATURE study, visit
http://www.marshalledwardsinc.com/. About Phenoxodiol Phenoxodiol
is an investigational drug and, as such, is not marketed in the
United States or other countries. Phenoxodiol targets the plasma
membrane sphingomyelin pathway, inhibiting the production of the
pro-survival secondary messenger, sphingosine-1- phosphate (S-1-P).
Resistance to carboplatin is associated with increased S- 1-P
levels, and the selective inhibition of production of S-1-P by
phenoxodiol is believed to account for the ability of phenoxodiol
to restore the sensitivity of tumor cells to carboplatin.
Phenoxodiol is highly selective, with no detectable effect on the
sphingomyelin pathway of non-tumor cells, this accounting for the
fact that phenoxodiol has no augmenting effect on the toxic effects
of chemotoxic drugs on normal tissues. About Ovarian Cancer Ovarian
cancer is the most lethal gynecological malignancy, and the fifth
leading cause of cancer related death in women in the United
States. The American Cancer Society estimates that there will be
about 22,220 new cases of ovarian cancer in this country in 2005.
About 16,500 women will die of the disease. One in 68 women will
develop ovarian cancer and one out of 100 women will die from this
disease. This high mortality is due mainly to the inability to
detect early disease, with approximately 80 percent of patients
being diagnosed in advanced-stage disease. However, even in those
patients diagnosed with early-stage disease, the five-year survival
rate ranges from 60 to 90 percent depending on the degree of tumor
differentiation. The standard first-line treatment of ovarian
cancer is a platinum drug (cisplatin or carboplatin) used alone or
coupled with a taxane (such as paclitaxel). In patients with
advanced disease, 80 to 90 percent will respond to first-line
chemotherapy. Of patients who respond to first-line chemotherapy,
less than 10 to 15 percent of these will remain in remission, and
most relapsed cases are chemo-resistant, showing little if any
further sensitivity to platinums or taxanes. Drugs such as
gemcitabine, doxorubicin and topotecan are used commonly in
subsequent lines of chemotherapy, but the development of
chemo-resistance to first-line drugs extends in large measure also
to these other drugs. The failure of some ovarian cancers to
respond to first-line chemotherapy (chemo- insensitivity) and the
development of resistance to multi-drug therapies
(chemo-resistance) represent the major hurdles to effective therapy
of ovarian cancer. Clinicians recognize an urgent need to devise
strategies that will both improve the response rate and degree of
response to chemotoxic drugs in the first instance, and/or will
restore chemo-sensitivity in late-stage ovarian cancer patients who
have become refractory to standard chemotherapies. About Marshall
Edwards, Inc. Marshall Edwards, Inc. (NASDAQ:MSHL) (LSE-AIM: MSH)
has licensed rights to bring phenoxodiol to market globally from
its parent company, Novogen Limited (NASDAQ:NVGN) (ASX:NRT).
Novogen is developing a range of therapeutics across the fields of
oncology, cardiovascular disease and inflammatory diseases based on
its phenolic drug technology platform. More information on the
Novogen group of companies can be found at http://www.novogen.com/.
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials and approved by the FDA as being
safe and effective for the intended use. Statements included in
this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties in clinical trial results; our inability
to maintain or enter into, and the risks resulting from our
dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization,
marketing, sales and distribution of any products; competitive
factors; our inability to protect our patents or proprietary rights
and obtain necessary rights to third arty patents and intellectual
property to operate our business; our inability to operate our
business without infringing the patents and proprietary rights of
others; general economic conditions; the failure of any products to
gain market acceptance; our inability to obtain any additional
required financing; technological changes; government regulation;
changes in industry practice; and one-time events. We do not intend
to update any of these factors or to publicly announce the results
of any revisions to these forward-looking statements. DATASOURCE:
Marshall Edwards, Inc. CONTACT: David Sheon, +1-202-518-6384 (USA),
for Marshall Edwards, Inc.; or Dr. Graham Kelly, Chairman of
Marshall Edwards, Inc., +1-203-247-1322 (USA) or +0412 307 057
(Australia) Web site: http://www.marshalledwardsinc.com/
http://www.novogen.com/
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