UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
report (date of earliest event reported): October 3, 2006
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-32353
|
84-1475642
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
(Address
of principal executive offices) (Zip Code)
(646)
214-0700
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other Events.
On
October 3, 2006, the Company issued a press release announcing its presentation
of updated clinical data on ZIO-101, one of the Company’s product candidates.
The Company’s press release dated October 3, 2006 is attached hereto as Exhibit
99.1 and incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated October 3, 2006.
2
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 hereunto
duly authorized.
| ZIOPHARM Oncology, Inc.: | ||
| (Registrant) | ||
| |
|
|
| Date: October 3, 2006 | By: | /s/ Richard E. Bagley |
|
Richard E. Bagley, President, Chief Operating Officer and Chief Financial Officer |
||
3
Exhibit
Index
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release date October 3, 2006
|
4
Exhibit
99.1
ZIOPHARM
Presents ZIO-101 Phase I Solid Tumor Data; Maturing Data Opens Door to Multiple
Approval Pathways
ISTANBUL,
Turkey, Oct 03, 2006 (BUSINESS WIRE) -- ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP)
announced today presentation of updated clinical data on ZIO-101 at the European
Society of Medical Oncology meeting in Istanbul. The safety and dose-ranging
study provides substantial evidence of clinical activity in a variety of solid
tumors. The Company believes that these results warrant an expanded phase II
program in solid tumors in addition to the recently announced phase II trial
program in hematologic cancers.
The
maximum tolerated dose (MTD) of ZIO-101 was 420 mg/me2/d given for 5 consecutive
days every 4 weeks. There were few adverse effects at or below the MTD and
no
clinically-important QTc-prolongation. The MTD dose of ZIO-101 is >50-fold
higher than the FDA-approved daily dose of arsenic trioxide (Trisenox(R)).
ZIOPHARM anticipates beginning phase II studies in both solid and hematological
cancers in the near future.
"The
latest results with ZIO-101 continue to excite," commented Dr. Brian Schwartz,
Chief Medical Officer at ZIOPHARM. "The opportunity to have potential choices
for multiple approval pathways, based on growing evidence of clinical activity
in a number of cancers is especially helpful."
Results
from the ongoing phase I solid tumor trial with ZIO-101, a novel organic
arsenic, are maturing. Of the 29 subjects receiving ZIO-101, 8 benefited. Seven
have stable disease including 3 with colorectal cancer, 2 with renal cell
cancer, one with head and neck cancer and one with a spinal cord tumor. An
eighth with pancreas cancer had a substantial decrease of a liver metastasis.
ZIO-101
is a small molecule licensed from The University of Texas M. D. Anderson Cancer
Center and Texas A&M University. ZIO-101 is also in phase I/II studies in
patients with advanced myeloma. In addition to phase II studies utilizing the
established MTD, the Company plans to explore alternative dosing schedules
in
the near future. The Company anticipates reporting final data from the study
reported here at upcoming medical meetings.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The Company applies new insights from
molecular and cancer biology to understand the efficacy and safety limitations
of approved and developmental cancer therapies and identifies proprietary and
related molecules for better patient treatment. For more information, visit
www.ziopharm.com.
Forward-Looking
Safe Harbor Statement:
This
press release contains forward-looking statements for ZIOPHARM Oncology, Inc.
that involve risks and uncertainties that could cause the Company's actual
results to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are based on
current expectations, forecasts and assumptions that are subject to risks and
uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Among other things, there can be no assurance
that any of the Company's development efforts relating to its product candidates
will be successful, or such product candidates will be successfully
commercialized. Other risks that affect forward-looking information contained
in
this press release include the possibility of being unable to obtain regulatory
approval of the Company's product candidates, the risk that the results of
clinical trials may not support the Company's claims, and risks related to
the
Company's ability to protect its intellectual property and its reliance on
third
parties to develop its product candidates. The Company assumes no obligation
to
update these forward-looking statements, except as required by law.
99-1
ZIOP-G
SOURCE:
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc.
Investors
Suzanne
McKenna, 646-214-0703
or
Media
Tina
Posterli, 917-322-2565
tposterli@rxir.com
99-2