NEW HAVEN, Conn., July 25, 2014 /PRNewswire/ -- Oncology drug
developer, CanTx Inc., and its parent company, Novogen Ltd. (ASX;
NRT: NASDAQ; NVGN), today announced that they have named two key
contract manufacturing organizations (CMOs) to produce clinical
batches of the experimental anti-cancer drug, Cantrixil™.
CanTx and Novogen expect to file an Investigational New Drug (IND)
application for Cantrixil early next year and to advance this
compound into the clinic by mid- 2015.
Cantrixil, being developed by CanTx Inc, a joint venture company
between Novogen and Yale University,
has been developed specifically to treat cancers wholly or largely
confined to the abdomen. It is comprised of the active drug, Trx-1,
contained within a cyclodextrin carrier and is intended to be
injected into the peritoneal cavity of patients. If shown to be as
safe and as effective in clinical studies as it has in animal
studies, Cantrixil could be the first anti-cancer drug approved as
an intra-peritoneal therapy.
The potential of Cantrixil has emerged from studies at Yale,
where researchers have developed ground-breaking screening tools to
assess new drug candidates in the treatment of ovarian cancer.
"I have tested over a hundred new compounds in this model from
many companies and never achieved any result that would give me
confidence to take any of them into the clinic. Trx-1 was the first
drug to show potent efficacy in the laboratory in killing ovarian
cancer stem cells, the cells responsible for tumor growth and
recurrence," said Professor Gil Mor,
M.D., Director of the Reproductive Science Division at the
Department of Obstetrics Gynecology and Reproductive Science at
Yale. "We decided that the best way to use Trx-1 was to inject it
directly into the abdominal cavity where the ovarian cancer stem
cells occur and are establishing the cancer. That was the concept
behind Cantrixil and I am delighted to say that we found that it
worked in our animal model."
Trx-1 is the first drug shown to have any meaningful anti-cancer
action against ovarian cancer stem cells, and Cantrixil is the
first product shown to block the development of carcinomatosis in a
mouse model developed by Yale to replicate the growth of ovarian
cancer in women.
The companies chose Illinois-based Regis Technologies, Inc, for
its ability to scale-up quickly and with extensive experience in
chiral chemistry. Regis will be producing the active pharmaceutical
ingredient, Trx-1.
Maryland-based Pharmaceutics
International, Inc., will manufacture the finished dosage form of
Trx-1 in cyclodextrin as a sterile injectable formulation that
meets stringent manufacturing, sterility and stability regulations
set down by the U.S. Food and Drug Administration (FDA).
"It is a pleasure to be working with two great CMOs. Both have
proven track records in being able to meet exacting standards and
timelines," Dr. Andrew Heaton,
Novogen Group Vice-President, Drug Discovery and Manufacture, said.
"Both also have a strong history of assisting companies with the
development of formulations, from pre-clinical through to
commercial manufacture. Having relationships with such companies
also meets our long term corporate goal of seeing Cantrixil
progress from an experimental to a commercial product."
Novogen Group CEO, Graham Kelly,
PhD, emphasized the significant nature of these contracts. He said:
"We are developing a product that we expect eventually to be the
first anti-cancer drug approved specifically as an intra-peritoneal
therapy. A number of hospitals currently give standard anti-cancer
drugs intra-peritoneally off-label for the treatment of ovarian
cancer and some other abdominal cancers, but that heightens their
toxicity, meaning that this approach remains cautious. In our
hands, Cantrixil has proven to be well tolerated in animals at
doses delivering a significant anti-cancer effect."
"This is an exciting path that we are now on," Dr. Kelly
continued. "The manufacturing programs currently underway will
furnish us with sufficient drug to complete the IND process and to
undertake Phase 1 studies in patients with late-stage ovarian
cancer in 2015."
Trx-1has been licensed by Novogen to CanTx.
About Cantrixil
Cantrixil is a construct of active
ingredient, Trx-1, in a cyclodextrin carrier. Trx-1 is a
super-benzopyran compound selected for its potent ability to kill
ovarian cancer stem (CD44-positive) cells and their daughter cancer
(CD44-negative) cells. Trx-1 inhibits electron-transfer mechanisms
across cell membranes, resulting in both caspase-dependent and
caspase-independent cell death. Trx-1
is a pan-acting anti-cancer agent with potent activity against a
wide range of human cancer cell types including pancreatic cancer
and colo-rectal cancer. In addition to its utility in the treatment
of ovarian cancer, Cantrixil also is being investigated
pre-clinically for its utility in the treatment of pancreatic
cancer and certain other cancers of the abdominal cavity.
About Novogen Limited
Novogen is a public,
Australian drug-development company whose shares trade on both the
Australian Securities Exchange ('NRT') and NASDAQ ('NVGN'). The
Company has two main drug technology platforms: super-benzopyrans
(SBPs) and anti-tropomyosins (ATMs). SBP compounds have been
created to have a uniform cytotoxic effect against both cancer stem
cell and are being developed in the first instance for the
treatment of ovarian cancer, neural cancers (glioblastoma,
neuroblastoma) and prostate cancer. ATM compounds target the cancer
cell cytoskeleton and are being developed for the treatment of
melanoma and prostate cancer.
Further information is available on the Company's website,
www.novogen.com.
About CanTx, Inc.
CanTx Inc. is a joint venture
between Novogen and Yale
University. Novogen owns 85% of CanTx. Novogen
has licensed Trx-1 to CanTx and that company is focused on the
development of novel therapies that target the cancer stem cells of
tumors that arise within the abdominal cavity. CanTx is based
in New Haven, CT. Further
information is available on the Company's website,
www.can-tx.com.
For Further Information Contact:
Investors
In the USA
Lazar Partners
+1 212-867-1762
Novogen@lazarpartners.com
Media
In the USA
Lazar Partners
+ 1 212-867-1762
Novogen@lazarpartners.com
In Australia
Dr. Douglas Pretsell
Instinctif Partners
+61 (0)3 9657 0706
In ROW
Sue Charles
Instinctif Partners
+44 (0)20 7457 2020
Logo -
http://photos.prnewswire.com/prnh/20131220/NY36990LOGO
SOURCE Novogen Limited