6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]
Published on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington. D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
I5d-16UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of June , 2003
Novogen Limited
(Translation of registrants name into English)
140 Wicks Road, North Ryde, NSW, 2113, 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 v Form 40-F
[Indicate by check mark whether 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
[If Yes is marked, indicate below the file number
assigned to the registrant in connection with Rule 12g3-2
(b):
82- ________________ .1
SIGNATURES
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)
Date 2 June, 2003 By
*Print the name and title under the signature of the
signing officer.Ronald Lea Erratt
Company secretary
GENERAL INSTRUCTIONS
A. Rule as to Use of Form 6-K.
are required to furnish reports pursuant to Rule l3a-16 or
15d-16 under the Securities Exchange Act of 1934.
B. Information and Document Required to be Furnished.
Subject to General Instruction D herein, an issuer furnishing
a report on this form shall furnish whatever information, not
required to be furnished on Form 40-F or previously furnished.
such issuer (i) makes or is required to make public pursuant
to the law of the jurisdiction of its domicile or in which it
is incorporated or organized, or (ii) files or is required to
file with a stock exchange on which its securities are traded
and which was made public by that exchange, or (iii)
distributes or is required to distribute to its security holders.
SEC 1815 (7-91)
The information required to be furnished pursuant to (i)
(ii) or (iii) above is that which is material with respect
to the issuer and its subsidiaries concerning: changes in
business; changes in management or control;
acquisitions or dispositions of assets; bankruptcy or
receivership; changes in registrants certifying
accountants; the financial
condition and results of operations; material legal
proceedings; changes in securities or in the security for
registered securities; defaults upon senior securities;
material increases or decreases in the amount outstanding
of securities or indebtedness; the results of the
submission of matters to a vote of security holders;
transactions with directors, officers or principal
security holders; the granting of options or payment
of other compensation to directors or officers; and
any other information which the registrant deems of
material importance to security holders.
This report is required to be furnished promptly after
the material contained in the report is made public as
described above. The information and documents furnished
in this report shall not be deemed to be filed for
the purposes of Section I8 of the Act or otherwise
subject to the liabilities of that section.
If a report furnished on this form incorporates by
reference any information not previously filed with
the Commission, such information must be attached as
an exhibit and furnished with the form.
C. Preparation and Filing of Report.
This report shall consist of a cover page, the document
or report furnished by the issuer, and a signature page.
Eight complete copies of each report on this form shall
be deposited with the Commission. At least one complete
copy shall be filed with each United States stock exchange
on which any security of the registrant is listed and
registered under Section 12(b) of the Act. At least
one of the copies deposited with the Commission and
one filed with each such exchange shall be manually
signed. Unsigned copies shall be conformed.
D. Translations of Papers and Documents into English.
Reference is made to Rule 12b-l2(d) [17 CFR 240.l2b-12(d)].
Information required to be furnished pursuant to General
Instruction B in the form of press releases and all
communications or materials distributed directly to
security holders of each class of securities to which
any reporting obligation under Section 13(a) or 15(d)
of the Act relates shall be in the English language.
English versions or adequate summaries in the English
language of such materials may be furnished in lieu of
original English translations.
Notwithstanding General Instruction B, no other documents
or reports, including prospectuses or offering circulars
relating to entirely foreign offerings, need be furnished
unless the issuer otherwise has prepared or caused to
be prepared English translations, English versions or
summaries in English thereof. If no such English
translations.
versions or summary have been prepared, it will be s
ufficient to provide a brief description in English of
any such documents or reports. In no event are copies
of original language documents or reports required to
be furnished.
ASX & MEDIA RELEASE 2 JUNE 2003
YALE RESEARCHERS DISCOVER THAT PHENOXODIOL COMBINED WITH SMALL DOSES
OF CHEMOTHERAPY REDUCES OVARIAN CANCER TUMOR MASS BY 75 PERCENT
Novogen Limiteds subsidiary, Marshall Edwards Inc. (LSE-AIM: MSH),
has
just made the following announcement to the London
Stock Exchanges Alternative Investment Market.
(CHICAGO, Ill. June 3, 2003) Researchers from Yale University School
of Medicine today presented data indicating that phenoxodiol, a
synthetic anti-cancer compound manufactured by Novogen Limited, when
added to low levels of standard chemotherapy agents, produces
dramatic reductions in the size of human ovarian cancer tumors in animals.
The data were presented today at the 39th Annual Meeting of the
American Society of Clinical Oncology.
The Yale researchers previously have shown that phenoxodiol was the
most effective drug in the test tube in killing ovarian cancer cells
that were resistant to standard chemotherapeutics.
The new data is an important development in showing that this
potent anti-cancer effect of phenoxodiol is retained in vivo.
In a further development, the Yale researchers also showed that
phenoxodiol had the ability to render ovarian cancer cells more
susceptible to the cytotoxic effects of standard anti-cancer drugs.
Ovarian cancer is a particularly deadly disease, in large part because
of resistance to chemotherapy.
Standard doses of chemotherapy produce unfortunate side effects, many
of which are not well tolerated by patients with ovarian cancer.
Our research indicates that the addition of phenoxodiol may
significantly reduce the amount of chemotherapy necessary to induce
tumor shrinkage and cancer cell death, said Gil Mor, MD PhD.,
Associate Professor, Department of Obstetrics and Gynecology, Yale
University School of Medicine. From this data, it appears that
phenoxodiol restores the ability of a cancer cell to be killed
with low doses of chemotherapy. If that holds true in patients,
this is very good news.
Animals received cisplatin (0.5mg/kg), or phenoxodiol at 10 or
20 mg/kg for eight days alone or in combination with cisplatin
(0.5 mg/kg). While cisplatin alone had no effect on tumor size,
the combination of phenoxodiol (10mg/kg) and cisplatin (0.5mg/kg)
reduced tumor mass by 75 percent.
Phenoxodiol currently is being evaluated as a monotherapy in Phase
II trials in patients with prostate cancer, ovarian cancer, and
squamous cell carcinoma.
Yale Medical School is conducting the Phase II study in ovarian
cancer patients who are resistant to standard chemotherapies.
That study is being conducted under an IND granted by the US FDA
for phenoxodiol as a monotherapy.
These new results confirm our confidence in phenoxodiols ability
to treat cancer as a single agent, said Graham Kelly, PhD.,
Executive Chairman, Marshall Edwards, Inc.
But they also point to a strategy that might increase the potency
of phenoxodiol even more, by combining it with standard anti-cancer
drugs, but at levels that might not be associated with adverse
side-effects.
The action of phenoxodiol is unique among the new generation of
anti-cancer drugs in that it exerts multiple effects on cancer cells,
but no apparent effects on non-cancer cells.
A variety of enzyme systems are switched off including protein
tyrosine kinases, sphingosine kinase and cyclin-dependant kinases.
The primary target is thought to be interruption to the
phosphorylating ability of kinases, making phenoxodiol the first
pan kinase inhibitor to be tested in the clinic.
The outcome of this action is initiation of apoptosis through
up-regulation of death receptor activity.
Phenoxodiol represents the next generation of anti-cancer drugs--
it appears to work on multiple pathways to induce cancer cells to
self destruct while having no meaningful toxicity on healthy cells,
said Steven Knapp, portfolio manager, Simba Management Group.
Phenoxodiol appears to be the first drug to specifically hit a target
that is only present on cancer cells.
FDA's apparent commitment to getting promising cancer drugs to late
stage cancer patients combined with phenoxodiol's safety profile and
early indications of clinical success convinces me that phenoxodiol's
path to the market has been accelerated.
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials. After the results of these trials
are submitted in a new drug application to the FDA, the FDA must
approve the drug as safe and effective before marketing can take
place.
Statements herein that are not descriptions of historical facts
are forward-looking and subject to risk and uncertainties.
Actual results could differ materially from those currently
anticipated due to a number of factors, including those set
forth in the Companys Securities and Exchange Commission
filings under Risk Factors, including risks relating to the
early stage of products under development; uncertainties relating
to clinical trials; dependence on third parties; future capital
needs; and risks relating to the commercialisation, if any, of
the Companys proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition
and other risks).
Novogen (Nasdaq: NVGN) is a world leader in the research and
development of drugs derived from its phenolic technology
platform.The Company manages its international
research and development programs using the expertise
and clinical research capabilities
of universities and hospitals in the U.S., Australia and
other key international locations. The oncology
compound phenoxodiol is
being developed by the Company's listed subsidiary
Marshall Edwards Inc. (LSE-AIM: MSH).
ISSUED FOR : MARSHALL EDWARDS INC
FOR FURTHER PROFESSOR ALAN HUSBAND, VICE
PRESIDENT RESEARCH,
INFORMATION : TEL (02) 9878 0088
http://www.novogen.com
DAVID SHEON TEL +1 202 518 6384