SYDNEY /PRNewswire/
-- US-Australian drug discovery company, Novogen Limited (ASX: NRT;
NASDAQ: NVGN) (Company),
announced today that its candidate cytotoxic chemotherapy drug,
Anisina, has proved an effective anti-cancer agent in animals, the
result of which it now has been fast-tracked by the Company to come
into the clinic.
Anisina targets
the cytoskeleton of cancer cells. This is the same target of the
most widely used chemotherapy drugs in cancer, the taxanes and
vinca alkaloids. These latter drugs are standard of care for some
of the most common cancers in adults embracing both solid cancers
(breast, ovary, prostate, lung, bladder, testicle) and non-solid
cancers (acute leukaemias, Hodgkin's Disease), as well as in
pediatric cancers (neuroblastoma, Wilm's tumor). Beyond these
approved uses, they are widely used off-label across most forms of
cancers following failure of standard of care drugs.
Despite their
common use, the taxanes and vinca alkaloids come with the
significant disadvantages of (i) being non-selective, resulting in
significant side-effects, (ii) not working in many forms of cancer,
and (iii) readily inducing resistance in cancer cells.
There remains a
significant clinical need to improve on both the efficacy and
safety of these commonly used drugs. Novogen believes that Anisina
has the features to meet that need across a range of cancer
types.
The taxanes and
vinca alkaloids target a structural component of the cytoskeleton
known as the microtubule. De-stabilizing this structure prevents
the cancer cell from dividing and promotes its death.
Anisina is a
first-in-class drug candidate that targets the other main
structural component of a cancer cell known as the
microfilament.
There is a
20-year history of attempts to produce drugs against
microfilaments. The commercial success of the taxanes and vinca
alkaloids in the 1970s validated the cancer cell's cytoskeleton as
a target for anti-cancer drugs, making the destruction of the
microfilaments an obvious alternative drug target. These attempts
failed because of the inability to limit the destructive effect to
cancer cells' microfilaments, with loss of muscle function being a
pronounced toxic side-effect.
The breakthrough
came 10 years ago with the discovery by Professor Peter
Gunning and Dr Justine
Stehn at theUniversity
of New South Wales (Sydney,
Australia) of the role of a structural protein known as
Tmp3.1 in the function of microfilaments. Cancer cells are far more
reliant on Tmp3.1 for the integrity of their microfilaments than
are normal cells. Anisina specifically targets Tmp3.1, destroying
the microfilaments of cancer cells with proportionally much less
effect on normal cells.
Compared to the
taxanes and vinca alkaloids, Anisina offers three potential
advantages, viz. (i) being more selective against cancer
cells, (ii) being able to kill cancer cell types inherently
insensitive to taxanes and vinca alkaloids, and (iii) not being
subject to the same drug-resistance mechanisms that affect the
taxanes and vinca alkaloids.
Ahead of bringing
Anisina into the clinic, Novogen has focused on three
indications -- melanoma, prostate cancer,
neuroblastoma -- with animal studies underway in each
indication in support of IND applications over the next 9
months.
We have
previously announced that Anisina is active in vitro against human
melanoma cells, a cancer that is relatively insensitive to the
taxanes and vinca alkaloids. We also have announced that Anisina
kills human melanoma cells irrespective of their mutational
status.
Today's
announcement concerns the important key step of establishing a
significant anti-tumour effect in vivo. The study reported here is
with melanoma; the neuroblastoma animal studies are being reported
to a scientific conference on July
13; the prostate cancer studies will be reported shortly
after that.
Mice bearing the
human malignant melanoma cell line A-375 (BRAF-mutant) were treated
with Anisina either intravenously (60 mg/kg/twice weekly) or orally
(100 mg/kg/daily). Both dosing regimens delivered a significant
anti-tumor effect with no observed toxicity.
Justine Stehn
PhD, Novogen Anti-Tropomyosin Program Director, said, "This result
clears the way for Anisina to enter the clinic. The potent effect
observed here of the drug on a cancer as difficult to treat as
malignant melanoma, combined with the lack of any obvious toxicity
of the drug, justifies our earlier speculation that destroying a
cancer cell's microfilaments would yield an equivalent therapeutic
benefit to destroying the microtubules, but without the toxicity of
the latter."
"Large-scale
manufacture of the compound now is underway with a target of being
in a first-in-man study in 2Q16," Stehn added.
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 drug technology platforms
yielding drug candidates that are first-in-class with potential
application across a broad range of degenerative diseases. In the
oncology field, the ultimate objective is to see both drug
technologies used in combination as first-line therapy across most
forms of cancer, with the objective of preventing tumor recurrence.
This objective is based on a strategy of achieving comprehensive
destruction of the full hierarchy of cells within a tumor with the
super-benzopyran technology platform killing the tumor-initiating
cells and the anti-tropomyosin technology, combined with vinca
alkaloids, to deliver a potent chemical debulking effect on their
daughter cells.
For more
information, please visit www.novogen.com
Corporate Contact
Dr.
Graham Kelly
Executive
Chairman & CEO
Novogen
Group
[email protected]
+61
(0) 2 9472 4101
Media Enquiries
Kym
Robins
Marketing
and Communications Manager
Novogen
Group
[email protected]
+61
(0) 2 9472 4109
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, Anisina, 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
Anisina, 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, Anisina, 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 Anisina, 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.