<SEC-DOCUMENT>0001193125-19-137434.txt : 20190506
<SEC-HEADER>0001193125-19-137434.hdr.sgml : 20190506
<ACCEPTANCE-DATETIME>20190506060709
ACCESSION NUMBER:		0001193125-19-137434
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20190506
FILED AS OF DATE:		20190506
DATE AS OF CHANGE:		20190506

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			KAZIA THERAPEUTICS 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:		19797988

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NOVOGEN LTD
		DATE OF NAME CHANGE:	19981228
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d741483d6k.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<HTML><HEAD>
<TITLE>FORM 6-K</TITLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 6-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of May, 2019 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number
<U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Kazia
Therapeutics Limited </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of registrant&#146;s name into English) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive office) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
20-F&nbsp;&nbsp;&#9745;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F&nbsp;&nbsp; &#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>: 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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>:
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&#146;s &#147;home country&#148;), or under the rules of the home country exchange on which the registrant&#146;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&#146;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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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&nbsp;&nbsp;&#9744;&nbsp;&nbsp;&nbsp;&nbsp; No&nbsp;&nbsp;&#9745; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If
&#147;yes&#148; is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b) </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia Therapeutics Limited</B> <B></B>(Registrant) </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Kate Hill </U></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kate Hill </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Company Secretary </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date 6&nbsp;May 2019 </P>
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<IMG SRC="g741483g78r77.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ASX RELEASE </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">6 May 2019 </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA ANNOUNCES SUPERIOR SAFETY AND TOLERABILITY DATA FROM PHASE IIA STUDY OF <FONT STYLE="white-space:nowrap">GDC-0084</FONT> IN <FONT
STYLE="white-space:nowrap">NEWLY-DIAGNOSED</FONT> GLIOBLASTOMA PATIENTS </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>Dose Expansion Cohort to Begin Recruitment
Immediately;</I></B> <B><I> </I></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>Top-line Data Expected in 4Q Calendar 2019</I></B> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 6 May 2019</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to
announce new safety data from its ongoing phase IIa study of GDC-0084 in newly-diagnosed patients with glioblastoma (GBM). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Licensed from Genentech in
October 2016, GDC-0084 is a novel targeted therapy that inhibits the PI3K pathway, which is important in many forms of cancer and is activated in 85-90% of GBM cases. GDC-0084 is administered orally, once daily. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The phase IIa study has determined a maximum tolerated dose (MTD) of 60mg, which is substantially higher than the 45mg dose found during Genentech&#146;s
phase&nbsp;I study in patients with recurrent disease. Dose-limiting toxicities in this phase IIa study included oral mucositis (mouth ulcers) and hyperglycemia (elevated blood sugar), both of which are expected effects of the PI3K inhibitor class
of drugs. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr James Garner, Chief Executive Officer of Kazia Therapeutics commented, &#147;this is an important milestone, and we are very encouraged by
these results. Genentech&#146;s original phase I study examined GDC-0084 in very advanced patients, who are often less able to tolerate therapy. They reached an MTD of 45mg, which is expected to be within the therapeutic range. When we licensed the
drug from Genentech, we recognized the opportunity to refocus around newly-diagnosed patients, who are often in generally better health. The fact that the drug appears better tolerated here than in the previous study validates our strategy for <FONT
STYLE="white-space:nowrap">GDC-0084,</FONT> and bodes well for the clinical efficacy of the drug.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia&#146;s phase IIa study of GDC-0084 is
designed in two parts. The first part, which began dosing in September 2018 and is now complete, is a dose optimization component, designed to determine if newly-diagnosed patients could tolerate a higher dose of
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> than advanced recurrent patients. This part of the trial was expected to enroll between 6 and 18 patients, depending on the safety signal observed. Ultimately, a total of eight patients were required
for this part. The study will now immediately transition into the dose expansion cohort, in which an additional 20 patients will be recruited. It is planned that these patients will receive a dose of 60mg. This second part of the study will be
designed to provide confirmatory efficacy signals, and is expected to report initial data in the fourth quarter of calendar 2019. </P> <P STYLE="margin-top:48pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Board of Directors
</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman"><B>Mr Iain Ross </B>Chairman,<B> </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director<B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman"><B>Mr Bryce Carmine </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director<B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman"><B>Mr Steven Coffey </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director<B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman"><B>Dr James Garner </B>Chief Executive Officer, Managing Director </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In total, seven sites in the United States are currently participating:- </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


<TR>
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<TD WIDTH="47%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Site</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Principal Investigator</B></P></TD></TR>


<TR BGCOLOR="#cceeff" STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Dana Farber Cancer Institute, Boston, MA</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Prof. Patrick Wen</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">MD Anderson Cancer Center, Houston, TX</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Prof. John de Groot</TD></TR>
<TR BGCOLOR="#cceeff" STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">John Theurer Cancer Center, Hackensack, NJ</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Dr. Samuel Goldlust</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Massachusetts General Hospital, Boston, MA</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Dr. Elizabeth Gerstner</TD></TR>
<TR BGCOLOR="#cceeff" STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Stephenson Cancer Center, Oklahoma City, OK</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Asst. Prof. James Battiste</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">University of California Los Angeles, Los Angeles, CA</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Prof. Tim Cloughesy</TD></TR>
<TR BGCOLOR="#cceeff" STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">University of Colorado Cancer Center, Aurora, CO</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Asst. Prof. Denise Damek</TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study is registered on clinicaltrials.gov as NCT03522298. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Garner added, &#147;the total clinical experience with GDC-0084 is now approaching 70 patients. The side effects that we have seen to date have all been
very typical for this type of drug: mouth ulcers, high blood sugar, etc. Critically, we have not seen any of the more serious side effects that have sometimes been observed with other drugs in the class, such as infections, liver toxicity, or
gastrointestinal problems. This is very reassuring as we prepare to take the drug forward into the next phase of development.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">[ENDS]
</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited</B> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia
Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a
range of oncology indications. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to
treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, GDC0084 entered a phase II clinical trial in 2018. Preliminary efficacy data is expected in 4Q 2019. <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> was granted orphan designation for glioblastoma by the US FDA in February 2018. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">TRX-E-002-1 (Cantrixil), is a
third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer.
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> is currently undergoing a phase&nbsp;I clinical trial in Australia and the United States. Initial data was presented
at the AACR annual conference in April 2019 and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
