SYDNEY, June 24, 2015 /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 the University 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
Graham.Kelly@novogen.com
+61 (0) 2 9472
4101
|
Media
Enquiries
Kym Robins
Marketing and
Communications Manager
Novogen
Group
Kym.Robins@novogen.com
+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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/anisina-on-track-to-enter-clinic-in-2016-300103803.html
SOURCE Novogen Ltd