Marshall Edwards, Inc. (NASDAQ: MSHL) -- Preliminary results from a
Phase II clinical trial of oral phenoxodiol in patients with
prostate cancer to be presented by Yale researchers at the ASCO
Genitourinary Cancers Symposium in Orlando, Florida, February
26-28, 2009 became available in abstract form on the ASCO website
today. The research was led by Kevin Kelly, DO, Associate Director,
Solid Tumor Investigation, Yale Cancer Center.
The abstract relates to a poster presentation which will review
data supporting the anti-tumor effects of phenoxodiol as studied in
patients with advanced prostate cancer (Group A) and in patients
with early stage, pre-metastatic disease where prostate specific
antigen (PSA) levels were rising after radical prostatectomy or
radiation therapy (Group B). Twenty five (25) patients have been
treated to date -- 16 in Group A and 9 in Group B. Interim analysis
shows that among Group A patients, 1 remains on therapy without
disease progression for greater than 6 months and 1 patient had a
greater than 50% post-therapy PSA decline, while 5 patients in
Group B (56%) had stable disease for a median time of 3 months.
"Oral phenoxodiol was very well tolerated with no severe adverse
events reported to date. More importantly, we observed some
evidence of clinical activity, especially in the early stage
disease group, in terms of holding disease progression in check,"
said Dr. Kelly. "Further studies evaluating the impact of
phenoxodiol on serum cytokines will be explored at the completion
of the trial."
In another related development concerning the potential for
phenoxodiol as a therapeutic in prostate cancer, a paper was
published today in the British Journal of Cancer reporting that, in
addition to its potential as a single agent therapeutic,
phenoxodiol is able to enhance the activity of cisplatin and
carboplatin against prostate cancer cells in vitro(1). This study,
conducted by Professor Paul de Souza and colleagues of the
Department of Medical Oncology at St. George Hospital in Sydney,
Australia concluded "that phenoxodiol has interesting properties
that make combination therapy with cisplatin or carboplatin
appealing."
About phenoxodiol:
Phenoxodiol is being developed by the US oncology company
Marshall Edwards, Inc. (NASDAQ: MSHL) as a chemosensitizing agent
in combination with platinum drugs for late stage, chemoresistant
ovarian cancer and as a monotherapy for prostate and cervical
cancers. It has a unique mechanism of action, binding to cancer
cells via a surface oxidase, causing major downstream disturbances
in expression of proteins necessary for cancer cell survival and
responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the
pro-survival regulator known as S-1-P (sphingosine-1-phosphate)
that is overexpressed in cancer cells. In response to phenoxodiol,
the S-1-P content in cancer cells is decreased, rendering those
cells more sensitive to chemotherapy. Indeed, in laboratory
studies, it has been demonstrated that cancer cells pre-treated
with phenoxodiol were killed with lower doses of chemotherapy
drugs.
Importantly, phenoxodiol has been shown not to adversely affect
normal cells in animal and laboratory testing. Phenoxodiol has
received Fast Track status from the FDA to facilitate its
development as a therapy for recurrent ovarian and prostrate
cancers. Phenoxodiol is an investigational drug and, as such, is
not commercially available. 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.
Phenoxodiol is the first of a family of compounds in the
Marshall Edwards, Inc. drug pipeline of flavanoid derivatives.
Phase III Phenoxodiol Clinical Trial for Ovarian Cancer
Continues
The OVArian TUmor REsponse (OVATURE) trial is a major
multi-center multinational Phase III clinical trial of orally
administered phenoxodiol in combination with carboplatin in women
with advanced ovarian cancer resistant or refractory to
platinum-based drugs, to determine its safety and effectiveness
when used in combination with carboplatin. More information on the
trial can be found at http://www.OVATUREtrial.com.
The OVATURE trial is recruiting ovarian cancer patients whose
cancer initially responded to chemotherapy, but has since become
resistant or refractory to traditional platinum treatments. The
trial consists of two double blind treatment arms. Patients in one
trial arm are receiving weekly carboplatin and phenoxodiol.
Patients in the other trial arm are also receiving weekly
carboplatin, but a placebo (an inactive control pill) is
substituted for phenoxodiol. Neither patients nor their doctors
know to which trial arm the patients are randomly assigned.
A change from receiving platinum in the traditional dose pattern
(every two to three weeks) to a weekly dosing regimen has been
reported to provide a tumor response in some patients with
recurrent ovarian cancer.(2-4) Thus, in addition to learning more
about the safety and efficacy of phenoxodiol, researchers will
learn more about the efficacy and safety of weekly carboplatin.
The primary outcome of the trial is the assessment of the
relative time it takes for the ovarian cancer to progress. An
analysis of interim results will be possible after patient
recruitment to this study is completed and 95 patients have disease
progression.
Patients are being recruited at hospital sites across the USA,
UK, Europe and Australia. The trial design has been approved by the
US Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA) program, and provides for an interim analysis of
the data, which, if statistically significant, can be used to
support a request for accelerated marketing approval.
About Marshall Edwards, Inc.
Marshall Edwards, Inc. is a specialist oncology company focused
on the clinical development of novel anti-cancer therapeutics.
These derive from a flavonoid technology platform, which has
generated a number of novel compounds characterized by broad
ranging activity against a range of cancer cell types with few side
effects. The combination of anti-tumor cell activity and low
toxicity is believed to be a result of the ability of these
compounds to target an enzyme present in the cell membrane of
cancer cells, thereby inhibiting the production of pro-survival
proteins within the cell. Marshall Edwards has licensed rights from
Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring three oncology
drugs -- phenoxodiol, triphendiol and NV-143 -- to market globally.
Marshall Edwards' lead investigational drug, phenoxodiol, is in a
Phase III multinational multi-centered clinical trial for patients
with recurrent ovarian cancer. More information on the trial can be
found at http://www.OVATUREtrial.com.
Marshall Edwards is majority owned by Novogen, Limited (ASX:
NRT) (NASDAQ: NVGN), an Australian biotechnology company that is
specializing in the development of therapeutics based on a
flavonoid technology platform. More information on phenoxodiol and
on the Novogen group of companies can be found at
www.marshalledwardsinc.com and www.novogen.com.
(1) McPherson, R.A., Galettis, P.T. and de Souza, P.L..
Enhancement of the activity of phenoxodiol by cisplatin in prostate
cancer cells. Br.J.Cancer 2009; 100 (4):649-655.
(2) Piura B and Meirovitz M. Weekly single-agent carboplatin in
heavily pretreated patients with recurrent ovarian, peritoneal and
fallopian tube carcinoma. Eur J Gynaecol Oncol.
2005;26(4):386-90.
(3) Van der Burg ME, van der Gaast A, Vergote I, Burger CW, van
Doorn HC, de Wit R, Stoter G, Verweij J. What is the role of
dose-dense therapy? Int J Gynecol Cancer. 2005 Nov-Dec;15 Suppl
3:233-240.
(4) CaDron I, Leunen K, Amant F, Van Grop T, Neven P, Vergote I.
The Leuven dose-dense paclitaxel/carboplatin regimen in patients
with recurrent ovarian cancer. Gynecol Oncol
2007;106(2):354-61.
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 party 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.
Contacts: Alan Husband + 61 2 9878 0088 (Australia) Email
Contact Warren Lancaster 203 966 2556 Email Contact
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