SYDNEY, May 14, 2015 /PRNewswire/ -- US-Australian drug
discovery company, Novogen (NRT:ASX; NVGN: NASDAQ), today announced
that it has confirmed that drug candidate, Anisina, is an effective
monotherapy against human melanoma in an animal model.
The Company announced recently that Anisina was a potent
cytotoxic in vitro against human melanoma cells, and in particular
that this effect was unaffected by the mutational status of the
melanoma cells, particularly the common Braf gene status.
The purpose of the pre-clinical study was to provide evidence
that this potent anti-cancer effect could be transferred to the
whole animal. Such evidence is required to justify conducting human
clinical studies in adults with solid cancers such as melanoma. The
Company previously has announced the effectiveness of Anisina as a
monotherapy in mice bearing human neuroblastoma tumors, thereby
justifying taking it into clinical trials in children and juveniles
with solid cancers such as neuroblastoma. Taken together, the two
results confirm the potential clinical benefit of this drug across
both adult and paediatric cancers.
In the current study, highly chemo-resistant human melanoma
cells were grown in athymic mice and the animals treated either
orally or intravenously with Anisina. Both dosage forms were
equally effective.
Novogen Anti-Tropomyosin Program Director, Justine Stehn PhD,
said, "We are pleasantly surprised by the degree of anti-tumor
activity of this drug candidate on its own. We had always seen the
anti-tropomyosin technology as being an adjunct therapy for the
more commonly used anti-mitotic drugs. The rationale behind its
development was to destroy that half of a cancer cell's
cytoskeleton that the anti-mitotic drugs didn't target. We reasoned
that destabilising the entire cytoskeleton would achieve a much
higher level of anti-cancer effect than that coming from targeting
either half alone. And, indeed, that is what we see. Anisina used
in combination with anti-mitotic drug, vincristine, increases the
anti-cancer potency of vincristine 20-fold."
Stehn added, "Despite all the
evidence showing that Anisina has the potential to be just as
effective a stand-alone chemotherapy as the anti-mitotic drugs, we
still intend to see Anisina as a
companion drug for an anti-mitotic drug. The initial patients,
however, will need to be treated with Anisina on its own, and this
study now gives us the green light to proceed into a Phase 1 study
in the first half of 2016."
In preparation for both adult and paediatric clinical studies,
the Company is conducting studies in a variety of both adult and
paediatric solid and non-solid cancer types in order to determine
the optimal drug combination. Data of the effectiveness of Anisina
in combination with vincristine in animals bearing human
neuroblastoma tumors is being presented to a conference in
July 2015.
Graham Kelly, Novogen Group CEO,
said, "Each step in the drug development process continues to build
our confidence in the potential for this exciting first-in-class
drug. The fact that we know its target and how it works; the fact
that it is making the most commonly used drugs in chemotherapy work
20-times better, as well as looking like we can extend the
effectiveness of the combination into tumor types traditionally
unresponsive to anti-mitotic drugs; the fact that, in the case of
melanoma anyway, its effectiveness is unaffected by mutational
status; and the fact that it can be delivered conveniently by the
oral route and in that form was well tolerated by animals with no
observed side-effects: all these factors point to a highly
versatile and promising new drug candidate with potentially broad
application across the cancer spectrum."
About Anisina
Anisina is a small molecule that specifically targets the
tropomyosin isoform, Tpm3.1. Tropomyosins provide a rigid external
scaffold to the central actin core of the microfilament component
of a cell's cytoskeleton. Without this rigidity, the microfilaments
are inactive. There are over 40 different forms (isoforms) of
tropomyosin of which Tpm3.1 is one. Tpm3.1 is present in all cells;
normal cells are able to survive and function without Tpm3.1;
cancer cells are highly dependent on the presence of Tpm3.1 for
their survival and function. Exposure of cancer cells to Anisina
leads to disassembly of their microfilaments, prevention of
mitosis, and cell death. Anisina shows little or no effect on
normal cells at therapeutic doses.
About Anti-mitotic drugs
Anti-mitotic drugs are drugs that block cell division (mitosis).
This a shorthand term to describe a family of drugs that embraces
the taxanes (paclitaxel, docetaxel, Abraxane) and vinca
alkaloids (vincristine, vinblastine, Vineralbine) and which
work by blocking the ability of cells to divide (mitosis). Their
anti-cancer action is based on their inhibition of the protein,
tubulin, which is the principal component of microtubules, which
along with microfilaments, make up a cell's cytoskeleton. The
cytoskeleton (microtubules and microfilaments) is critical to most
cell functions, but particularly cell signalling, receptor
function, and mitosis.
The anti-mitotic drugs remain among the most widely prescribed
anti-cancer drugs after 35 years of use and are standard of care
for breast, prostate, lung, ovarian, colo-rectal, gastric and head
and neck cancer, and many forms of leukaemia.
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 debunking effect on their
daughter cells.
For more information, please visit www.novogen.com.
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, 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.
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SOURCE Novogen Ltd