SYDNEY, April 21, 2015
/PRNewswire/ -- US-Australian drug discovery company, Novogen,
today announced that its subsidiary joint venture company with
Yale University, CanTx, Inc, has today
received notification from the U.S. Food and Drug Administration
(FDA) that its chemotherapy candidate drug, Cantrixil, has been
granted Orphan Drug Designation for ovarian cancer.
Orphan Drug Designation is an important development for any
experimental drug and has been instigated in a number of
territories including the U.S, Europe and Australia to encourage the development of
drugs for clinical indications that do not have a high
incidence.
Orphan Drug Designation can provide the following benefits to a
drug developer:
- Financial subsidization for clinical research
- Tax incentives
- Extended patent protection
- Enhanced marketing rights.
Cantrixil was granted Orphan Drug Designation under the U.S.
Orphan drug Act following a review by the FDA of a package of
pre-clinical data submitted by the Company.
Novogen and CanTx CEO, Graham
Kelly, said, "Receiving this designation is one more step in
our objective of bringing Cantrixil to market as a drug that we
hope will provide meaningful clinical benefit to patients with
ovarian cancer and deliver that long-sought breakthrough for
patients with a cancer that has shown only slight improvement in
5-year survival rates over the last 30 years.
"CanTx came out of a belief by Yale
University and some long-term ovarian cancer researchers in
the Yale Medical School that Cantrixil
represented a potential breakthrough in the treatment of ovarian
cancer," Kelly added.
Key Cantrixil pre-clinical data was presented by Yale researchers two days ago at the American
Association of Cancer Research annual conference. That data
represented the final stringent challenge that CanTx and
Yale clinicians had set Cantrixil in
order to justify bringing it into patients. That data related to an
animal model believed to be highly representative of late-stage
chemo-resistant ovarian cancer. Cantrixil in that highly stringent
model delivered a very potent (>95% tumor reduction) anti-tumor
effect.
Cantrixil is on track to enter the clinic in Australia in late-2015/early-2016 in patients
with the condition, malignant ascites, a terminal condition
associated with cancers such as ovarian cancer and for which no
effective long-term therapies exist. The Company sees this as a
logical entry point into the clinic for the Cantrixil as being a
clinical indication without any approved therapies in the U.S. and
Australia, and as a prelude to the
ultimate objective of using Cantrixil much earlier in the cancer
process as a first-line therapy following diagnosis of ovarian
cancer.
"The capital-raise Novogen announced yesterday was intended to
give the Company the financial runway to bring drugs such as
Cantrixil through to the point where we hope to see objective
evidence of clinical efficacy. For Cantrixil, as for all our other
pipeline drugs, this is the next key inflection point for the
Company in its quest to become a major global drug discovery
company. The funds we hope to raise in the current Placement and
Rights Issue offerings are intended to take the Company to that
next key inflection point."
About Ovarian Cancer
Approximately 1 in 70 women will develop ovarian cancer in their
lifetime. In the U.S. this equates each year to approximately
22,000 new cases diagnosed and 15,000 deaths from ovarian cancer;
the figures for Europe are 66,000
and 41,000 respectively. There are different forms of ovarian
cancer with epithelial ovarian cancer accounting for 90% of
cases.
Approximately 15% of women present with disease localized to the
ovaries and with successful surgery, the 5-year survival rate is
>90%.
For women with more advanced disease at the time of diagnosis,
the 5-year survival rate is <30%.
Approximately 85% of advanced cases respond to first-line
therapy (typically paclitaxel and carboplatin), but about 80% of
these will relapse within several years.
About Cantrixil
Cantrixil is a cyclodextrin envelope containing the active
ingredient, TRXE-002. The construct has been designed as an
intra-cavity chemotherapy to be injected directly into the
peritoneal and pleural cavities without causing local irritation or
toxicity. Its purpose is to achieve high drug levels in the
environment in which the cancer is spreading through the migration
of the cancer stem cell. The ultimate primary indication of
Cantrixil to be sought is first-line therapy of early-stage cancers
of the abdominal cavity (e.g. ovarian, uterine, colo-rectal and
gastric carcinomas). Cantrixil will enter the clinic in later-stage
cancers where the abdominal carcinomatosis has resulted in the
terminal condition of malignant ascites.
Cantrixil is owned by CanTx, Inc.
About CanTx, Inc
CanTx is a joint venture company between Novogen and
Yale University. Novogen owns 85% of
the joint venture. Novogen has licensed the drug candidate,
TRXE-002, to CanTx for use in Cantrixil. CanTx is based in
New Haven, CT.
About Novogen
Novogen is a public, Australian-US drug-development company
whose shares trade on both the Australian Securities Exchange
('NRT') and NASDAQ ('NVGN'). The Novogen group includes US-based,
CanTx Inc, a joint venture company with Yale
University. Novogen has two main drug technology platforms:
super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP
compounds have been designed to kill the full heterogeneity of
cells within a tumor, but with particular activity against the
slowly-dividing, less differentiated cancer stem (tumor-initiating)
cell. The ATM compounds target the micro-filament component of the
cancer cell's cytoskeleton and have been designed to combine with
anti-microtubule drugs (taxanes, vinca alkaloids) to produce
comprehensive and fatal destruction of the cancer cell
cytoskeleton. The Company pipeline currently comprises two SBP drug
candidates (TRXE-002, TRXE-009) and one ATM drug candidate
(Anisina).
Corporate
Contact
Dr. Graham
Kelly
Executive Chairman
& CEO
Novogen
Group
Graham.Kelly@novogen.com
+61 (0) 2 9472
4100
|
Media
Enquiries
Cristyn
Humphreys
Chief Operating
Officer
Novogen
Group
Cristyn.Humphreys@novogen.com
+61 (0) 2 9472
4111
|
Forward Looking Statement
This press release contains "forward-looking statements"
within the meaning of section 27A of the Securities Act of 1933 and
section 21E of the Securities Exchange Act of 1934. The
Company has tried to identify such forward-looking statements by
use of such words as "expects," "appear," "intends," "hopes,"
"anticipates," "believes," "could," "should," "would," "may,"
"target," "evidences" and "estimates," and other similar
expressions, but these words are not the exclusive means of
identifying such statements. Such statements include, but are
not limited to any statements relating to the Company's drug
development program, including, but not limited to the initiation,
progress and outcomes of clinical trials of the Company's drug
development program, including, but not limited to, Cantrixil, and
any other statements that are not historical facts. Such
statements involve risks and uncertainties, including, but not
limited to, those risks and uncertainties relating to the
difficulties or delays in financing, development, testing,
regulatory approval, production and marketing of the Company's drug
components, including, but not limited to Cantrixil, the ability of
the Company to procure additional future sources of financing,
unexpected adverse side effects or inadequate therapeutic efficacy
of the Company's drug compounds, including, but not limited to,
Cantrixil, that could slow or prevent products coming to market,
the uncertainty of patent protection for the Company's intellectual
property or trade secrets, including, but not limited to, the
intellectual property relating to Cantrixil, and other risks
detailed from time to time in the filings the Company makes with
Securities and Exchange Commission including its annual reports on
Form 20-F and its reports on Form 6-K. Such statements are
based on management's current expectations, but actual results may
differ materially due to various factions including those risks and
uncertainties mentioned or referred to in this press release.
Accordingly, you should not rely on those forward-looking
statements as a prediction of actual future results.
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SOURCE Novogen Ltd