0001144204-14-037995.txt : 20140624 0001144204-14-037995.hdr.sgml : 20140624 20140617090716 ACCESSION NUMBER: 0001144204-14-037995 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20140617 FILED AS OF DATE: 20140617 DATE AS OF CHANGE: 20140617 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVOGEN LTD CENTRAL INDEX KEY: 0001075880 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29962 FILM NUMBER: 14924292 BUSINESS ADDRESS: STREET 1: LEVEL 1 STREET 2: 16 - 20 EDGEWORTH DAVID AVE CITY: HORNSBY NSW STATE: C3 ZIP: 2077 BUSINESS PHONE: 01161298780088 MAIL ADDRESS: STREET 1: LEVEL 1 STREET 2: 16 - 20 EDGEWORTH DAVID AVE CITY: HORNSBY NSW STATE: C3 ZIP: 2077 6-K 1 v381612_6k.htm FORM 6-K

 

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 June, 2014

Commission File Number _________

 

 

Novogen Limited

 (Translation of registrant’s 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 x         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 x

 

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 June 2014

 

 

 EX-99.1 2 v381612_ex99-1.htm EXHIBIT 99.1

Novogen and CanTx Announce Potency of Intra-Peritoneal Trx-1 Confirmed Against Chemo-Resistant Ovarian Cancer Stem Cells



Companies expect to commence first-in-human studies of Trx-1 in ovarian cancer in 1H15

Yale researchers present the latest in vitro and in vivo results at Drug Discovery and Therapy 2014 World Congress

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