UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December, 2014
Commission File Number
Novogen
Limited
(Translation of registrants name into English)
16-20 Edgeworth David Ave, Hornsby, NSW 2077, Australia
(Address of principal executive office)
Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F þ Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted
solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ¨
Note: Regulation S-T Rule 101(b)(7) only
permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated,
domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is
not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark if the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission
pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes ¨ No þ
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Novogen Limited (Registrant)
Lionel Mateo
Lionel Mateo
Company Secretary
Date 16 December 2014
NOVOGEN ANNOUNCES BREAKTHROUGH DISCOVERY IN THE TREATMENT OF MELANOMA
16 December 2014, Sydney, Australia: Novogen Limited (ASX:NRT; NASDAQ:NVGN): Australian/US biotechnology company, Novogen Limited,
today announces that it has confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, has been shown in pre-clinical studies also to be highly active against melanoma.
The Company believes this is an important breakthrough discovery for two reasons. The first is that it confirms that TRXE-009 is an important new potential
treatment for melanoma, including for the treatment of secondary brain cancers due to melanoma, for which there currently are no effective therapies. The second is that it offers evidence for the first time of an hypothesized link between brain
cancer and melanoma.
The link has long been considered a possibility because nerve cells and melanocytes (the melanin pigment-bearing cells in skin that
lead to melanoma) have a common origin in the embryo known as the neural crest. This primitive tissue gives rise to the neural cells that go on to form the brain, spinal cord, and peripheral nerves, as well as cells that form the structures of the
skull; melanocytes also come from this embryonic tissue. Up till now, no functional link has been found between brain cells and melanocytes, or between brain cancer and melanoma. TRXE-009 is the first compound to demonstrate the possibility of a
common link, suggesting that is the first drug with the ability to identify cancers arising in cells that have the neural crest as their common origin.
TRXE-009 has been confirmed as a potential new treatment for both adult and paediatric neural cancers. TRXE-009 previously has been announced as a world-first
in having exceptionally high killing activity against adult brain cancer (glioblastoma multiforme) stem cells, and against the paediatric brain cancers - medulloblastoma and DIPG (diffuse interstitial pontine glioma) - all tumors that are highly
resistant to known chemotherapies. That same high potency is now confirmed against melanoma cells, with activity unaffected by the tumors BRAF gene status.
Dr Graham Kelly, Novogen Group CEO, said, This latest finding brings the value of TRXE-009 into true perspective for us. We initially developed the
compound for brain cancer. We saw it as the first chemotherapy with the potential to make a meaningful difference to the survival prospects of patients, both adult and children, with primary brain cancer.
From there we looked at its ability to kill other cancers of neural origin, and discovered that the same potency against brain cancer cells extended to
neuroblastoma cells, a potential deadly cancer in children that arises in peripheral nerve tissue outside of the brain.
With the realisation
that we arguably had the first anti-cancer drug capable of recognising cancers arising in tissues with a common neural crest origin, it was an obvious next step to look at melanoma, with the outcome that we are announcing today, Kelly
explained.
Novogen will be delivering TRXE-009 as a proprietary construct known as Trilexium. Trilexium has been developed to maximise the
bio-availability of the drug to cancer cells in the body. Animal xenograft studies of human cancer have confirmed the efficacy of Trilexium.
Kelly said,
This finding completely changes the outlook for this drug candidate. From a drug that was due to come into the clinic specifically for the treatment of adult and childhood neural cancers, we now are presented with a prospective treatment for
malignant melanoma, including the treatment of secondary brain cancers due to melanoma for which there currently is no effective therapy.
We naturally are keen to bring Trilexium into the clinic as soon as possible. said Kelly. But
our entire focus at the moment in terms of a clinical program is the product candidate, Cantrixil. That is where our efforts are centred and where our current financial resources are committed, with the objective of achieving the key inflection
point of transiting into a clinical-stage company as a firm strategy. Trilexium will enter the clinic only when we have been successful in raising funds specifically ear-marked for this project. Those discussions are current with interested
stakeholders.
About Novogen Limited
Novogen
is a public, Australian 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 main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to
kill the full heterogeneity of cells within a tumor, including the cancer stem cells. The molecular target is a trans-membrane electron-transfer pump mechanism oncogene that is common to all cancer cells. Cells die by respiratory distress and
mitochondrial disintegration.
The ATM compounds target the micro-filament component of the cancer cells cytoskeleton and have been designed to
combine with anti-microtubular drugs (taxanes, vinca alakaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.
The
Company pipeline comprises three SBP drug candidates (TRXE-002, TRXE-009, TRXE-0025) and one ATM drug candidate (Anisina).
About TRXE-009
TRXE-009 is an SBP compound generated by the Companys VAL-ID (Versatile Approach to Library-based Iterative Design) drug discovery process, with
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 a construct of drug
candidate, TRXE-009, in a proprietary oil-based formulation selected for its ability to maximize passage of drug across the cancer cell plasma membrane.
About Melanoma
Malignant melanoma (Stage 4), where the
cancer has spread away from the site of origin, remains a major unmet clinical need with limited effective treatment options. Main sites of metastasis are lungs, liver, brain, bones, and distant lymph nodes and skin. Immunotherapies (ipilumumab,
vemurafenib, vaccines), chemotherapy (dacarbazine, vinblastine), radiotherapy and surgery are used to prolong life in Stage 4 disease, but these modalities provide little benefit where metastases has occurred to the brain.
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
Operations Manager Novogen Group
Cristyn.Humphreys@novogen.com +61 (0) 2 9472
4111 |
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