Clinical Phase I Study Report of Marshall Edwards' Compound Triphendiol to Be Reported in ASCO Proceedings
NEW CANAAN, CT--(Marketwire - May 15, 2008) - An abstract submitted to the Annual Meeting
of the American Society of Clinical Oncology (ASCO), May 30-June 3,
Chicago, Illinois, entitled "Phase Ia Safety and Pharmacokinetic Study of
Oral NV-196 in Patients with Solid Tumours" is now available at
www.asco.org (Abstract# 14615). The abstract reports on a human clinical
study of oral triphendiol which demonstrated a good safety profile and
successful pharmacokinetics. The trial was conducted by Professor Paul
Mainwaring at the Brisbane Mater Adult Hospital in Brisbane, Australia.
NV-196, now known as triphendiol, was granted orphan drug status by the
U.S. Food and Drug Administration (FDA) for pancreatic cancer and
cholangiocarcinoma in January 2008 and for treatment of stage IIb-IV
malignant melanoma in February 2008.
Laboratory testing in vitro and in animals bearing human pancreatic and
bile duct tumors and in mice bearing human melanoma tumors has demonstrated
the activity of triphendiol against these cancer cells. In mice bearing a
human pancreatic cancer tumor, triphendiol administration resulted in a
mean reduction in tumor volume by 62 percent compared with untreated
Professor Alan Husband, Group Director of Research for Marshall Edwards,
says, "The study being presented at ASCO is an important step towards the
clinical development of triphendiol. These data indicate that oral
triphendiol appears to be safe and can be delivered effectively in humans.
"We will now be well placed to apply for an Investigational New Drug (IND)
approval to continue into Phase II studies in the U.S. later this year,"
Professor Husband said.
There is an urgent need for new pancreatic cancer treatments because fewer
than 20 percent of patients are candidates for surgery (pancreatectomy).
Current treatment is limited to chemotherapy with gemcitabine, to which
most patients are resistant or acquire resistance.
Pancreatic cancer is considered an "orphan" cancer because of its
relatively low incidence and high mortality. In the U.S., it is the fourth
leading cause of cancer-related death in men and women with the 5-year
relative survival rate of 5 percent of patients with the disease(1). The
American Cancer Society estimated the number of new cases of pancreatic
cancer in the U.S. in 2008 as 37,680, with 18,770 cases diagnosed in men
and 18,910 in women(1). An estimated 34,290 deaths from pancreatic cancer
are expected in 2008(1).
Pancreatic cancer has a poor prognosis. The disease is difficult to
diagnose in its early stage, and patients usually present with incurable
disease. It has a high mortality rate, and no therapy has been shown to
significantly impact survival.
Melanoma accounts for only 3 percent of all skin cancers; however, it
causes the greatest number of skin cancer-related deaths worldwide(2). It
is responsible for more than 77 percent of skin cancer deaths(2). An
estimated 62,480 (34,950 men and 27,530 women) new cases with malignant
melanoma, were expected to occur only in the US in 2008(1). An estimated
8,420 deaths from melanoma are expected in 2008(1).
Triphendiol (NV-196) is another investigational drug in the Marshall
Edwards, Inc. oncology drug pipeline, currently being developed as an
orally-delivered chemosensitizing agent, intended for use in conjunction
with standard chemotoxic anticancer drugs for the treatment of late stage
pancreatic cancer, cholangiocarcinoma (bile duct cancer), and melanoma.
Triphendiol is broadly cytostatic and cytotoxic against most forms of human
cancer cells in vitro, and has been shown to cause cell cycle arrest (or
stop cells increasing in number) and to induce apoptosis (or initiate
programmed cell death) in various cancer cell lines.
Biological studies suggest a mechanism of cytotoxicity that involves
mitochondrial depolarization and down-regulation of XIAP. It exhibits high
selectivity, little effect on non-tumor cells and no observable toxicity in
animals at therapeutically effective doses. In human studies conducted so
far, no adverse events or side effects have been reported when administered
About Marshall Edwards, Inc. and Novogen Limited
Marshall Edwards, Inc. (NASDAQ: MSHL) is a specialist oncology company
focused on the clinical development of novel anticancer therapeutics. These
derive from a flavonoid technology platform that has generated a number of
novel compounds characterized by broad ranging activity in laboratory
testing against a range of cancer targets with low toxicity. The ability of
these compounds to target an enzyme present on the surface of cancer cells,
and inhibit the production of pro-survival proteins within the cancer cell
suggests that they may possess a unique combination of efficacy and safety.
Marshall Edwards, Inc. has licensed rights from Novogen Limited (ASX: NRT)
(NASDAQ: NVGN) to bring three oncology drugs -- phenoxodiol, triphendiol
(NV-196) and NV-143 -- to market globally. Marshall Edwards, Inc. is
majority owned by Novogen, an Australian biotechnology company that is
specializing in the development of therapeutics based on a flavonoid
Novogen, based in Sydney, Australia, is developing a range of therapeutics
across the fields of oncology, cardiovascular disease and inflammatory
diseases. More information on phenoxodiol and on the Novogen group of
companies can be found at www.marshalledwardsinc.com and www.novogen.com.
Under US 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.
1 American Cancer Society: Cancer Facts and Figures 2008. Atlanta, GA:
American Cancer Society, 2008.
2 Ries LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L,
Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer
Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD,
http://seer.cancer.gov/csr/1975_2004/, based on November 2006 SEER data
submission, posted to the SEER web site, 2007.
Contact Information: For further information:
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TEL 202 470-2880