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 April, 2015
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
If yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b)
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 17 April 2015
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ASX:NRT
NASDAQ:NVGN
Novogen Ltd (Company)
ABN 37 063 259 754
Capital Structure
Ordinary Shares on issue:
276 M
Board of
Directors Dr Graham Kelly
Chairman & Executive Director
Steve Coffey Non Executive Director
John OConnor
Non Executive Director
Prof Peter Gunning Non Executive Director |
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MARKET RELEASE 17 April
2015 NOVOGEN AND FEINSTEIN INSTITUTE JOIN FORCES TO FIND EFFECTIVE
TREATMENTS FOR BRAIN CANCER
TRXE-009 distinguished by ability to kill chemo-resistant adult
and paediatric brain cancer cells
Studies to optimize delivery of TRXE-009 to brain cancer tissue
17 April 2015. Sydney AUSTRALIA: US-Australian drug discovery company, Novogen,
today announced that it had signed a Memorandum of Understanding with the Feinstein Institute for Medical Research (Feinstein Institute) of New York to collaborate with the objective of developing effective treatments for brain
cancers. The collaboration brings together the drug discovery expertise of Novogen and
the preclinical and clinical expertise of the Feinstein Institute in neurosciences and oncology.
At the heart of the collaboration is the Companys super-benzopyran (SBP) drug technology platform, distinguished by its ability to kill the full spectrum
of cells within a tumor including both rapidly- and slowly-dividing cancer cells (tumor-initiating cells).
The three key areas of research will be:
1. the development of lead SBP drug candidate, TRXE-009, as a treatment of both primary
and secondary brain cancer in adults and children, including glioblastoma and medulloblastoma;
2. the potential ability of the SBP technology (based on early evidence) to deliver an
entirely novel approach to chemotherapy by converting cancer stem cells into stem cells displaying normal stem cell behaviour;
3. the development of drug candidates as radio-sensitizers designed to augment the
effectiveness of radiotherapy in treating brain cancers. TRXE-009 (Trilexium) is a
pan-acting (across all forms of cancer) anti-cancer cytotoxic molecule that is on track to enter the clinic in early-2016 for the treatment of solid and non-solid cancers. A particularly high activity against melanoma cells has been announced
previously and malignant melanoma is expected to be a key clinical indication to be pursued. For this purpose, TRXE-009 will be delivered systemically in a way that the Company has confirmed in animal studies delivers the drug in a bio-available
form in the bloodstream that delivers a potent anti-tumor effect on tumors growing outside of the brain. The task now remains to confirm that TRXE-009 can be delivered to brain cancer tissue in adequate amounts.
TRXE-009 has proven to be particularly effective in vitro against adult (glioblastoma) and
paediatric (diffuse intrinsic pontine glioma; medulloblastoma) brain cancer cells, marking it as a unique and highly promising drug candidate for the treatment of these cancers. The collaboration announced today is focused specifically on these
tumors and the need to optimize the delivery of TRXE-009 to cancerous tissue within the brain. |
Novogen CEO Graham Kelly, PhD, said today, We are confident that we have found the drug that can successfully treat
cancers arising in the brain as well as cancers that spread to the brain from elsewhere. The ability of TRXE-009 to kill brain cancer stem-like cells gives us particular confidence that we can finally kill off the root cause of any cancer within the
brain.
The proviso is that we can deliver it across the blood-brain barrier, and that is something that we will not know with any certainty
until we bring TRXE-009 into the clinic. The collaboration with the Feinstein Institute is designed to maximize that likelihood. If we can do that, then we have a good chance of delivering breakthrough treatment options to adults and children with
primary brain cancers and for patients with cancers such as melanoma that involve the brain and elsewhere, added Kelly.
Using models developed in
the laboratory by the Feinstein Institute, the ability of TRXE-009 to treat various forms of human brain cancer will be studied using a variety of new approaches, such as direct microinjection into the brain (convection enhanced delivery) and
intravenous administration with a range of constructs known to facilitate the transport of drugs across the blood-brain barrier, some of which have been developed by Novogen chemists.
This collaboration between the Feinstein Institute and Novogen is critical to supporting the discovery of new treatments for patients who suffer from
life-threatening brain cancer, said John A. Boockvar, MD, who co-directs the Feinstein Institutes Brain Tumor Biotech Center with Marc Symons, PhD.
Patients who suffer from brain cancer dont have optimal therapies to turn to. By offering them new, improved treatments, we will give hope to
patients who face a devastating disease.
About Super-Benzopyrans and TRXE-009
Super-benzopyrans (SBPs) are small molecules based on an expanded benzopyran molecular structure. They display pleiotropic biological properties involving both
pro-survival and pro-death functions based on particular structural properties. TRXE-009 has been selected for its cytotoxicity against cancer cells. The mechanism of action is not fully elucidated and multiple molecular targets are thought to be
involved, including gene transcription factors. Inhibition of ion exchange mechanisms leading to loss of trans-membrane potential is a known target.
About The Feinstein Institute for Medical Research
Headquartered in Manhasset, NY, The Feinstein Institute for Medical Research is home to international scientific leaders in many areas including cancer,
Parkinsons disease, Alzheimers disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, human genetics, pulmonary hypertension, leukemia, neuroimmunology, and medicinal chemistry. The Feinstein Institute, part of the North
Shore-LIJ Health System, ranks in the top 6th percentile of all National Institutes of Health grants awarded to research centers. For more information, visit www.FeinsteinInstitute.org
About brain cancers
Cancers of the brain can be divided
into those that originate within the brain (primary brain cancers) and those that originate outside of the brain (secondary or metastatic brain cancers); lung cancer and melanoma are common causes of secondary brain cancers. The most common type of
primary brain cancer in adults is glioblastoma and in children is medulloblastoma. Treatment options involve surgery, radiotherapy and chemotherapy. Chemotherapy options are limited by two main factors: (1) the poor sensitivity of brain cancer cells
to chemotherapy drugs; and (2) the difficulty of transporting drugs to the brain across the blood-brain barrier. Only 1 in 5 adults diagnosed with malignant brain cancer will survive for at least 5 years. In the US and Australia, survival rates have
improved less than 2% over the past 30 years.
About Novogen Limited
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 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, but with particular activity against the cancer stem (tumor-initiating) cell.
The ATM compounds target the micro-filament component of the cancer cells cytoskeleton and have been designed to combine with anti-microtubule drugs
(taxanes, vinca alkaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.
The Company pipeline comprises two SBP drug
candidates (TRXE-002, TRXE-009) and one ATM drug candidate (Anisina).
Further information is available on our website www.novogen.com
For more information please contact:
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Corporate Contact Dr. Graham Kelly
Executive Chairman & CEO Novogen Group
Graham.Kelly@novogen.com +61 (0) 2 9472 4100 |
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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, target, evidences and estimates, and other similar expressions, but these words are not the exclusive means of
identifying such statements. Such statements include, but are not limited to any statements relating to the Companys drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the
Companys drug development program, including, but not limited to, TRXE-009, 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 Companys drug components, including, but not limited to TRXE-009, the ability of
the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Companys drug compounds, including, but not limited to, TRXE-009, that could slow or prevent
products coming to market, the uncertainty of patent protection for the Companys intellectual property or trade secrets, including, but not limited to, the intellectual property relating to TRXE-009, and other risks detailed
from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on managements current expectations, but actual
results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future
results.
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