Report of Foreign Issuer (6-k)
September 12 2016 - 7:02AM
Edgar (US Regulatory)
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 September, 2016
Commission File Number
Novogen
Limited
(Translation of registrant’s name into English)
Level 5, 20 George Street, 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 registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s 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 registrant’s 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)
Kate Hill
Kate Hill
Interim Company Secretary
Date 12 September 2016
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ASX:NRT
NASDAQ:NVGN
Novogen Ltd
(Company)
ABN 37 063 259 754
Capital Structure
Ordinary Shares on issue:
429 M
Board of Directors
Mr John O’Connor
Chairman
Non-Executive Director
Mr Bryce Carmine
Deputy Chairman
Non-Executive Director
Dr James Garner
Chief Executive Officer
Managing Director
Mr Ian Phillips MNZM
Non-Executive Director
Mr Iain Ross
Non-Executive Director
Mr Steven Coffey
Non-Executive Director
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MARKET RELEASE
12 September 2016
US FDA APPROVES INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR
CANTRIXIL
™
(TRX-E-002-1) IN OVARIAN CANCER
•
Cantrixil (TRX-E-002-1) is Novogen’s lead development candidate, and is being
developed as an intraperitoneal therapy for patients with ovarian cancer
•
Investigational New Drug (IND) application is the key regulatory filing to initiate
clinical trials in the United States
•
First-in-human (FIH) phase I study remains on track for initiation in 4Q 2016, as per
previous guidance
Sydney, 12th September 2016 – Australian oncology-focused
biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1)
had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may therefore proceed as planned.
Dr James Garner, CEO of Novogen, commented “we are grateful to the FDA for their thorough and comprehensive review of our submission, and we are pleased
to have their approval to move forward with the study. The team is already working alongside Quintiles, our contract research organisation, to make the necessary submissions to human research ethics committees at each of the participating sites, and
we continue to anticipate initiation of the phase I study in the fourth quarter of 2016, as previously indicated.”
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[ENDS]
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Media and Investor Relations
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Investor Relations (US)
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Glen Zurcher
E:
glen.zurcher@irdepartment.com.au
T: +61 420 249 299
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Robert Kennedy
E:
robert.kennedy@novogen.com
T: +1 212 519 9832 / +1 646 662 3574
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About the Cantrixil (TRXE-E-002-1) development candidate
Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRX-E-002-1, which has shown
in vitro
and
in vivo
anti-cancer activity in
a range of tumour types. The Company anticipates that, if approved, the drug product would be used as an intra-peritoneal chemotherapy, either alone or in combination with other agents, and in one or more cancers of the abdominal or pelvic cavity
(e.g. ovarian, uterine, colorectal or gastric carcinomas). A first-in-human clinical study is planned to commence in the fourth quarter of 2016.
About
Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an oncology-focused biotechnology company based in Sydney, Australia. Novogen has two
proprietary drug discovery platforms (superbenzopyrans and anti-tropomyosins) with the potential to yield first-in-class agents across a range of oncology indications. The three lead molecules Cantrixil, Anisina, and Trilexium are in preclinical
development, with the most advanced molecule, Cantrixil, slated to enter clinical trials in late 2016. For more information, please visit:
www.novogen.com
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