BOSTON, June 17, 2014 /PRNewswire/ -- Australian
oncology drug development company Novogen Limited [ASX:NRT;
NASDAQ:NVGN] and CanTx Inc., its joint venture with Yale University, today announced the success of
proof-of-concept pre-clinical studies confirming the potency of
experimental drug, Trx-1, in the treatment of primary ovarian
cancer when delivered into the peritoneal cavity. Based on the
potency seen in animal models to date, and the potential to prevent
recurrence, Novogen and CanTx believe that Intra-Peritoneal Trx-1
could be utilized as a first-line therapy for ovarian cancer.
Trx-1 is being developed for the treatment of ovarian cancer,
particularly for its ability to kill chemo-resistant ovarian cancer
stem cells. Novogen and CanTx plan to file an Investigational New
Drug application (IND) with the FDA in early 2015 and to start a
Phase 1 study by mid-2015.
The data presented today shows that Trx-1 can significantly
retard the growth of highly chemo-resistant, human ovarian cancer
stem cells in an animal model considered to be highly
representative of the human situation.
Gil Mor, M.D. Ph.D., Professor of
Obstetrics, Gynecology and Reproductive Science at Yale School of Medicine presented his group's
research on Trx-1 to date at the Drug Discovery and Therapy 2014
World Congress. The conference is taking place in Boston, June 16 to 19,
2014.
"Ovarian cancer is the most lethal of all the gynecologic
malignancies. These tumors are made up of two distinct kinds of
cells: cancer stem cells that initiate and perpetuate the tumor and
which resist all forms of chemotherapy, and their daughter cells
that, in most patients, respond initially to chemotherapy. Where
there is an initial response to therapy, it is because the
chemo-sensitive daughter cells that make up the bulk of the tumor
have responded. But the parent cancer stem cells then respond by
generating a new generation of daughter cells that now display the
same level of chemo-resistance as the parent cells. This is why
when ovarian cancer recurs it is so difficult, if not impossible,
to treat," Prof. Mor explained.
Prof. Mor and his colleagues at Yale
have identified and cloned the two main subtypes of ovarian cancer
cells representative of ovarian tumor complexity. CD44-/MyD88-
epithelial ovarian cancer (EOC) cells represent the bulk of ovarian
cancer cells: they are rapidly-dividing, short-lived, and can
respond to chemotherapy. CD44+/MyD88+ EOC cells are slow-growing,
very long-lived, exhibit tumor-initiating (stem cell-like)
properties, and are highly chemotherapy-resistant. These latter
cells are the source of tumor recurrence.
Prof. Mor said, "An obvious strategy is to be more successful in
treating primary disease, so that we stop the development of
recurrent disease. We need to be able to kill the ovarian cancer
stem cells before they have the chance to produce a second
generation of highly chemo-resistant daughter cells."
The animal model developed at Yale
involves injecting human CD44+/MyD88+ (cancer stem) cells into the
peritoneal cavity of mice, where they quickly establish highly
aggressive multiple tumors comprising both CD44+/MyD88+ cells and
recurrent CD44-/MyD88- cells, all highly chemo-resistant. This
animal model is representative of the human situation where ovarian
cancer generally is confined to the abdomen and the cells are free
to spread, leading to multiple tumors often involving dozens or
even hundreds of individual tumors. Faced with the challenge of
treating such scattered tumor load, the injection of anti-cancer
drugs directly into peritoneal cavity is an approach clinicians
have long considered.
"This is the first time that we've seen a compound have such a
profound effect on tumor growth and tumor burden in this highly
aggressive ovarian cancer animal model," Mor added. "The current
animal studies were all about proving the concept that an
intraperitoneal administration of Trx-1 was capable of reducing
tumor burden and carcinomatosis, the main cause of patient
mortality. We achieved this objective by preventing the
renewal and survival of human ovarian cancer stem cells," Mor
added. "This is a first important step in our goal of making
progress in the treatment of this insidious disease. We believe
that this now provides the platform for delivering a killer blow by
combining Trx-1 with conventional chemotherapy as a first-line
therapy and successfully removing all the cellular components of
the tumor."
"This is an exciting outcome that shows what can come of
commercial collaboration between industry and academia," said
Graham Kelly, Ph.D., CEO of both
Novogen and CanTx. "This result elevates our hopes for Trx-1 beyond
the usual recovery of patients with late-stage ovarian cancer, to
the exciting prospect of incorporating it into first-line therapy
in combination with conventional chemotherapy."
About Ovarian Cancer
The American Cancer Society estimates that over 22,000 women
will be diagnosed with ovarian cancer during 2013 and 14,230
American women will die from the disease. It ranks fifth in cancer
deaths among women, accounting for more deaths than any other
cancer of the female reproductive system. This cancer mainly
develops in older women. About half of the women who are diagnosed
with ovarian cancer are 63 years or older. It is more common in
white women that in African-American women.
About Novogen Limited
Novogen is a public, Australian drug-development company with
shares traded on both the Australian Securities Exchange ('NRT')
and NASDAQ ('NVGN'). The Company has two main drug technology
platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs).
SBP compounds have been created to have a uniform cytotoxic effect
against both cancer stem cell and are being developed in the first
instance for the treatment of ovarian cancer, glioblastoma and
prostate cancer. ATM compounds target the cancer cell cytoskeleton
and are being developed for the treatment of melanoma and
neuroblastoma.
Further information is available on the Company's website,
www.novogen.com.
About CanTx, Inc.
CanTx Inc. is a joint venture between Novogen and Yale University. Novogen owns 85% of
CanTx. Novogen has provided a license to CanTx to access the
Novogen library of super-benzopyran drugs for the development of an
intra-peritoneal treatment of cancers such as ovarian and
pancreatic cancers that are limited to the abdominal cavity.
CanTx is based in New Haven, CT. Further information is
available on the Company's website, www.can-tx.com.
For Further Information Contact:
Investors
In the USA
David Carey
Lazar Partners
+1 212-867-1762
Novogen@lazarpartners.com
Media
In the USA
Hollister Hovey/Allison Parks
Lazar Partners
+ 1 212-867-1762
Novogen@lazarpartners.com
In Australia
Dr. Douglas Pretsell
Instinctif Partners
+61 (0)3 9657 0706
In ROW
Sue Charles
Instinctif Partners
+44 (0)20 7457 2020
SOURCE Novogen Limited