SYDNEY, March 18, 2015 /PRNewswire/ -- Novogen announced
on 18th March, 2015 that one of its oncology pipeline
drug candidates, Anisina (ATM-3507), has achieved a major milestone
in its development, confirming the concept that comprehensive
destruction of a cancer cell's cytoskeleton can deliver a powerful
anti-cancer effect.
Dr Kelly was interviewed by Channel 7 health reporter, Dr
Andrew Rochford about Anisina's
potential. To view the interview click here… or visit
the Novogen website.
The cytoskeleton (cell skeletal structure) is a common and
validated target for anti-cancer therapy. The most commonly used
drugs in chemotherapy target the cytoskeleton by destabilising one
of its two key components, the microtubules. These drugs are known
as 'anti-mitotics' and include the taxanes (paclitaxel, docetaxel)
and the vinca alkaloids (vincristine, vinblastine). Collectively,
these anti-mitotics have dominated chemotherapy for the past 30
years and look set to do so for many years to come.
The rationale behind the development of Anisina was that the
anti-mitotic drugs only do half the job, because they leave the
other major component of the cytoskeleton, the microfilaments,
intact. It was reasoned that this half-complete destruction of the
cytoskeleton by the anti-mitotic drugs accounted for their low rate
of patient response for many tumor types and for the generally
short-term response to therapy. Anisina was developed specifically
to destroy the microfilaments and to work in combination with the
anti-mitotic drugs to deliver comprehensive destruction of the
cancer cell's architecture.
Anisina targets a specific protein known as tropomyosin Tpm3.1
(previously known as Tm5NM1). Tpm3.1 is a protein that provides
structural integrity to the microfilaments of a cell. It is present
in both normal cells and cancer cells, the difference being that
cancer cells have an increased reliance on this form of tropomyosin
to survive.
It has been announced previously that anti-tropomyosin drugs in
combination with anti-mitotic drugs boost the cancer-killing
ability of a drug such as vincristine 20-fold in vitro
against neuroblastoma cancer cells.
The next crucial step was to confirm that this powerful combined
anti-cancer effect was transferable to animals. The study reported
today confirms this.
This proof of concept study was done as part of the Children's
Oncology Drug Alliance (CODA) involving Australian charity, The
Kids' Cancer Project (Sydney), The
University of New South Wales
(Sydney), The Nationwide
Children's Hospital (Columbus,
Ohio), and Novogen. The studies were conducted using cancer
cells derived from children who had developed neuroblastoma.
The full details of these studies will be presented at the
Eighth Annual Cancer Molecular Therapeutics Research Association
(CMTRA) meeting in the USA in July
of this year.
Justine Stehn PhD, Novogen Anti-Tropomyosin Program Director,
said, "This was the crucial step we needed to bring Anisina into
the clinic. We now are proceeding to bring Anisina into the clinic
in 2016 into both adults and children. In adults we will be looking
to use Anisina to potentiate the anti-cancer effect of
anti-mitotics in cancers such as prostate, ovarian, lung, breast,
colorectal and haematological cancers, as well as in cancers such
as melanoma where anti-mitotics currently show little benefit."
"But what particularly excites us from a CODA perspective is the
promise that this technology holds in being able to achieve a
potent anti-cancer effect in children where anti-mitotics currently
are widely used, but being able to use lower dosages of
anti-mitotics that hopefully will lower the risk of leaving
children with side-effects with life-long consequences."
Graham Kelly PhD, Novogen CEO and Executive Chairman said, "From
the outset, the anti-tropomyosin technology platform has held the
promise of delivering a major new chemotherapy, one that we saw
becoming a standard companion drug to the most commonly-used drugs
in chemotherapy. Today's announcement just serves to reinforce that
promise."
"The promise of Anisina is that it is not a drug limited to
working in a proportion of patients with a particular form of
cancer, or one that is reliant on the over-expression of certain
functions such as immune checkpoints or pro-survival mechanisms.
Its promise lies in its ability to make the most widely-used
chemotherapy drugs work better and safer in more forms of cancer
and in more patients. Our objective is to see Anisina become one of
the most widely used drugs in chemotherapy."
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
mainly the taxanes (paclitaxel, docetaxel, Abraxane) and
vinca alkaloids (vincristine, vinblastine, Vineralbine) and
which work by blocking the ability of cells to divide (mitosis).
These remain among the most widely prescribed anti-cancer drugs
after 35 years of use. Anti-mitotic drugs are standard of care for
breast, prostate, lung, ovarian, colo-rectal, gastric and head and
neck cancer, and many forms of leukaemia.
About the cytoskeleton
The cytoskeleton provides the architecture of a cell. It is a
protein structure that gives a cell its shape, ability to move and
to divide and to store and move internal structures. It has two
main components: the microtubules and the microfilaments. The key
component of microtubules is the protein, tubulin, which is the
target of the anti-mitotic drugs, and whose destabilisation leads
to prevention of cell division (mitosis). The key components of the
microfilaments are the proteins, actin and tropomyosin.
About Tpm3.1
Tpm3.1 is a tropomyosin protein. Tropomyosins provide a rigid
external scaffold to microfilaments that have a central actin core.
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.
About Anisina
Anisina is a small molecule specifically designed to block the
ability of Tpm3.1 to dimerize. By fitting into the C-terminus of
the proximal Tpm3.1, it prevents dimerization of the N-terminus of
the distal tropomyosin protein. Interruption of dimerization leads
to the inability of the microfilaments in cancer cells to remain
stable, resulting in their collapse.
About CODA
CODA's mission is to accelerate development of innovative new
therapeutic approaches to the treatment of chlldhood cancers and to
take account of the fact that childhood cancers are different to
adult cancers and that the lifelong consequences of cancer drug
side-effects can be far more devastating in a child than in an
adult.
CODA unites the research and resources of five organisations in
Australia and the US.
The Australian members are:
- The charity, The Kids' Cancer Project
- The originator of the anti-tropomyosin technology,
the University of New South
Wales and its commercial arm, NewSouth
Innovations
- Biotechnology company, Novogen Limited
The US member is:
- Nationwide Children's Hospital, Columbus, Ohio
Novogen is providing access to both its anti-tropomyosin and
super-benzopyran drug technologies. Anisina is being evaluated for
its ability to complement the action of standard chemotherapies in
childhood cancers. TRXE-009 is being evaluated for its ability to
treat brain cancers in children.
Further information on CODA is available at
www.childrensoncologydrugalliance.org
About Novogen Limited
Novogen is a public, drug-development company whose shares trade
on both the Australian Securities Exchange ('NRT') and NASDAQ
('NVGN'). The Novogen Group includes a New Haven CT – based joint venture company,
CanTx Inc., with Yale University.
Novogen has two main drug technology platforms:
super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP
compounds have been created to kill the full range of cells within
a tumor, but particularly the cancer stem cells. The ATM
compounds target the microfilament component of the cancer cell and
when used in conjunction with standard anti-microtubule drugs,
result in comprehensive and fatal destruction of the cancer cell's
cytoskeleton. Ovarian cancer, colorectal cancer, malignant
ascites, prostate cancer, neural cancers (glioblastoma,
neuroblastoma in children) and melanoma are the key clinical
indications being pursued, with the ultimate objective of employing
both technologies as a unified approach to first-line therapy.
Further information is available on our websites
www.novogen.com
For more information please contact:
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,"
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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
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SOURCE Novogen Ltd