SYDNEY and SAN DIEGO, May 8, 2015 /PRNewswire/ -- US-Australian drug discovery company, Novogen Limited (ASX:NRT; NASDAQ:NVGN), in conjunction with Australian paediatric cancer researchers, released key pre-clinical data on experimental cancer drug-candidate, TRXE-009, confirming its potential to become an important new therapy against an incurable paediatric brain cancer called DIPG (diffuse intrinsic pontine glioma). The data was presented by David Ziegler MD PhD and Anne Kankean PhD of the University of New South Wales/Children's Cancer Institute at the 3rd Biennial Conference on Pediatric Neuro-Oncology Basic and Translational Research in San Diego, 7-8 May 2015.
DIPG has a very poor prognosis with a median survival of less than one year, a statistic that has not changed in over 50 years. DIPG is amongst the most challenging cancers to treat; the diffuse nature of the cancer means that surgery is not an option, radiation provides only temporary relief, and chemotherapy has yet to provide any clinical benefit.
The latest study looked at the ability of TRXE-009 to kill freshly established patient-derived cell cultures collected from patients with DIPG. The studies indicate that TRXE-009 kills DIPG cells at therapeutically relevant concentrations by inducing a specific type of cell death - caspase-dependent apoptosis. In contrast to its pronounced effect on DIPG cancer cells, normal brain astrocytes are affected only at much higher concentrations of TRXE-009, confirming data seen with other cancer cell types that TRXE-009 has a high therapeutic index and is able to target cancer cells at concentrations that have little effect on normal cells.
Lead Investigator David Ziegler said, "These are preliminary studies but we are very excited about the striking activity we are seeing in these highly resistant tumorspheres. TRXE-009 is one of the most potent compounds we have studied to date in this setting."
Novogen Trilexium Program Manager, Eleanor Ager, PhD said, "These findings add to our other pre-clinical studies suggesting that TRXE-009 has particular activity against brain cancers, including being highly cytotoxic against the main adult brain cancer, glioblastoma multiforme (GBM). The next step in this drug's development is to confirm its ability to cross the blood-brain barrier, a key filtering system that blocks the majority of chemotherapeutic drugs from reaching brain tissue".
TRXE-009 has been designed to cross the blood-brain barrier, but Novogen has further enlisted the combined efforts of several international research groups to identify the optimal means of delivering TRXE-009 to adults and children so that it crosses the blood-brain barrier.
Novogen Group Chief Executive Officer Graham Kelly, PhD said, "DIPG is a devastating disease for affected children and their parents alike. I don't want parents to think that this battle is won, because we have yet to make sure we can deliver this drug candidate at levels that that will make a difference. But what is important is to give parents of children with DIPG hope, and that is what this news hopefully does."
"TRXE-009 is an exciting prospect. It is broadly active against a wide range of cancers in the laboratory, including cancer stem cells, and on the basis of it delivering a potent anti-cancer effect in animals bearing human melanoma, we are bringing into the clinic in 2016 for the treatment of solid cancers. But in addition to a general anti-cancer use, the ultimate objective is to see it tested in adults and children with brain cancers, and people with secondary brain cancer associated with cancers such as melanoma."
About TRXE-009
TRXE-009 is a super-benzopyran compound that demonstrates cytotoxicity against cancer cells, but particularly activity against cancer cells with stem-cell like activity. The molecular target is undefined for this molecule, but is believed to be in common with other members of this family of compounds in blocking trans-membrane electron transfer mechanisms, leading to caspase-induced apoptosis. TRXE-009 is a product of the Company's VAL-ID (Versatile Approach to Library-based Iterative Design) drug discovery process, with a structure-activity relationship driving design based on activity against brain cancer stem cells and the known required chemical criteria to facilitate passage across the blood-brain barrier.
About Trilexium
Trilexium is the name given to a proprietary parenteral formulation of TRXE-009 selected for its ability to maximize systemic drug delivery and effectiveness in pre-clinical rodent models of human cancer.
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 +61 (0) 2 9472 4100 |
Media Enquiries Cristyn Humphreys Chief Operating Officer Novogen Group +61 (0) 2 9472 4111 |
Forward Looking Statement
All statements other than statements of historical fact included in this announcement including, without limitation, statements regarding future plans and objectives of Novogen Limited ("Novogen") are forward-looking statements. When used in this announcement, forward-looking statements can be identified by words such as 'may', 'could', 'should', 'would', 'believes', 'estimates', 'targets', 'expects' or 'intends' and other similar words that involve risks and uncertainties.
Such statements relate to future events and expectations and as such involve known and unknown risks and uncertainties. These risks and uncertainties include, among other things, market conditions, weather risks, economic and political risks.
These statements are based on an assessment of present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this announcement, are expected to take place. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of Novogen, its directors and management, which could cause Novogen's actual results to differ materially from the results expressed or anticipated in these statements.
Novogen cannot and does not give any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this announcement will actually occur and investors are cautioned not to place undue reliance on these forward-looking statements. Actual results, actions, and developments may differ materially from those expressed or implied by those forward-looking statements depending on a variety of factors.
Novogen does not undertake to update or revise forward- looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this announcement, except where required by applicable law and stock exchange listing requirements.
