SYDNEY, May 27, 2014 /PRNewswire/ -- Novogen Limited
(NASDAQ: NVGN, ASX:NRT), an oncology drug development company,
today announced that it has achieved a key milestone with its
super-benzopyran (SBP) drug program, having identified a number of
SBP compounds with potent anti-cancer activity against human
prostate cancer cells in vitro. As a result, Novogen has
extended its preclinical SBP program to include prostate cancer as
well as ovarian and brain cancers.
Prostate cancer cells are highly resistant to chemotherapy and
the few drugs approved for late-stage, hormone-resistant prostate
cancer offer only modest improvements in survival. There is thus an
urgent need to develop drugs specifically against prostate cancer
that will prolong life to a meaningful degree for these advanced
patients.
In a study conducted by Australian oncologist, Paul de Souza, M.D., Foundation Professor in
Medical Oncology at the University of Western Sydney's (UWS) and who is also
affiliated with the Ingham Institute, a number of SBP compounds
were tested in vitro against five different prostate cancer
cell lines that most closely mimic common clinical situations.
"There is a significant need for more effective treatments for
prostate cancer. It's exciting at long last to be working with new
compounds with such impressive activity against a panel of
clinically-relevant prostate cancer cell lines," Prof, de Souza
said. "With anti-cancer activity down around 50 nanomolar levels,
this group of chemicals appears to be at least as active as
standard cytotoxic drugs such as cisplatin. We now can work to
bring the lead compound into the clinic."
The studies in the laboratory of Professor de Souza are funded
by Novogen and are part of an international research program
initiated and coordinated by Novogen and involving some of the
world's most prestigious universities and hospitals. An ongoing
structural-activity-relationship drug discovery program has
produced a sub-family of SBP compounds with high potency against
prostate cancer cells. A lead candidate compound has been
identified and now will enter its lead optimization phase.
Professor de Souza will be the Lead Investigator in this
program, with the aim of testing the investigational drug as a
monotherapy in Australia in 2015
in men with advanced prostate cancer who have failed standard of
care. At the same time, Novogen will file an investigational new
drug (IND) application with the U.S. Food and Drug Administration
(FDA) seeking permission to conduct a U.S. clinical trial, also in
2015.
Novogen's proprietary SBP drug technology platform targets an
oncogene that appears to be common to all forms of cancer. The
oncogene produces a mutant form of an enzyme that regulates
fundamental biochemical processes within all cells. When inhibited,
the cell quickly dies. This mechanism of action offers the
potential for SBP drugs to avoid the common problems associated
with targeted therapies of the cancer cell being able to develop
alternative signaling pathways or multi-drug resistance mechanisms.
Other studies funded by Novogen at prestigious US universities have
already have identified two SBP structures with particular activity
against ovarian cancer and glioblastoma cells respectively.
Dr David Brown, Novogen Group
Chief Scientific Officer, said today, "The horizon for new and
effective chemotherapeutics for prostate cancer is bleak. This
discovery heralds in an entirely new and exciting area of clinical
development. Other SBP compounds have already shown a potent
ability to kill the full hierarchy of cancer cells within ovarian
cancer and the main form of brain cancer, glioblastoma, and we have
every confidence that what we are seeing in this study is the
potential to do the same thing with prostate cancer."
"The prostate cancer cells used in this study respond poorly
both in the laboratory and in the clinic to standard chemotherapy
drugs, so our ability to kill them at such low drug concentrations
suggests that we have broken through an important barrier."
Dr Graham Kelly, Novogen CEO,
said, "This discovery extends Novogen's clinical focus into an
entirely new area of cancer where patients desperately need new,
better treatment options. We're excited to be moving all three of
these programs forward towards human clinical trials."
About prostate cancer
Prostate cancer is the
second-most common cause of cancer-related death in males in
Western society. The American Cancer Society estimates that in
2014, about 233,000 new cases of prostate cancer will be diagnosed
and about 29,480 men will die of prostate cancer.
In men with late-stage disease where the cancer has metastasized
to the skeleton and is unresponsive to androgen–ablation therapy,
the standard of care includes the use of cytotoxic drugs (docetaxel
or cabazitaxel) in combination with prednisone, a drug
(abiraterone) that inhibits the production of testosterone and its
ability to stimulate androgen receptors in prostate cancer cells,
and a drug (zoledronic) that blocks the ability of prostate cancer
cells to thrive in bone. Collectively, these drugs typically
prolong life in men with late-stage prostate cancer by months, but
not years.
About super-benzopyran drugs
SBPs are a proprietary
family of compounds that inhibit the internal trans-membrane proton
pump mechanisms within cancer cells. The target is a nicotinamide
adenosine dinucleotide hydrogen (NADH) oxidase enzyme complex that
regulates the movement of protons (hydrogen ions) across cellular
membranes in support of a range of cellular functions including ATP
production. The NADH oxidase isoforms targeted are
tumour-associated, splice variants of normal NADH oxidases.
About Novogen
Novogen is a public, Australian
biotechnology company whose shares trade on both the Australian
Securities Exchange ('NRT') and NASDAQ ('NVGN'). The Company
is based in Sydney, Australia, and
with a U.S. office in New Haven,
Connecticut. The Company has two main drug technology
platforms known as super-benzopyrans (SBP) and anti-tropomyosins
(ATM).
SBP drugs have been designed to kill both cancer stem cells and
their daughter cells are being developed for the treatment of
ovarian cancer, glioblastoma (brain cancer) and prostate cancer.
Novogen has entered into a joint venture with Yale University known as CanTx, Inc. with the aim
of developing a novel approach to the treatment of ovarian cancer
with an intra-peritoneal product.
ATM drugs target the cancer cell cytoskeleton and are being
developed for the treatment of melanoma and neuroblastoma.
Novogen is part of CODA, an alliance between a number of parties
including an Australia charity,
The Kinds Cancer Project, and the Nationwide Children's Hospital in
Columbus, Ohio, to develop novel
treatments for childhood cancer.
Further information is available on the Company's website,
www.novogen.com.
For Further Information Contact:
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SOURCE Novogen Limited