Astex Pharmaceuticals Announces Initiation of SGI-110 Phase 2 Trial in Platinum-Resistant Recurrent Ovarian Cancer Patients
10/2/2012 6:00 AM EST
Astex Pharmaceuticals, Inc.
Press release
Astex Pharmaceuticals Announces Initiation of SGI-110 Phase 2 Trial in
Platinum-Resistant Recurrent Ovarian Cancer Patients
DUBLIN, Calif., 2012-10-02 12:00 CEST (GLOBE NEWSWIRE) -- Astex
Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the
discovery and development of novel small molecule therapeutics, announced that
it has initiated a Phase 2, open label, randomized, multi-center, controlled
clinical trial, evaluating SGI-110 in combination with carboplatin in
platinum-resistant recurrent ovarian cancer patients.
Study SGI-110-02 will have two stages: a safety lead-in stage (Stage A)
followed by a randomized, controlled, open-label stage (Stage B). In Stage A of
the study, patients will receive escalating doses of SGI-110 and carboplatin to
define the Maximum Tolerated Dose (MTD) and preliminary biological and clinical
activity. Once the MTD is defined, and biological activity confirmed, the study
will proceed to Stage B. In Stage B of the study, patients will be randomized
to receive SGI-110 plus carboplatin at the MTD identified in Stage A, or one of
three treatment of choice, standard of care agents, as determined by the
clinical investigator: topotecan, pegylated liposomal doxorubicin, or
paclitaxel. The primary endpoint in Stage B will be a comparison of progression
free survival (PFS) between SGI-110 plus carboplatin, and treatment of choice
study arms. Response rate and overall survival will be among the secondary
endpoints.
Stage A will enroll approximately 20 patients, and Stage B will enroll 96
patients.
The study is based on preclinical work showing that SGI-110 reverses platinum
resistance, and on a clinical study with Dacogen® and carboplatin showing a 35%
response rate and 10.2 months median PFS in heavily pretreated
platinum-resistant ovarian cancer patients (Matei et al, Cancer Res 2012;
72:2197–2205).
"There is a great need for agents to reverse platinum-resistance as platinum is
still the most active agent in ovarian cancer and other tumor types. This proof
of concept study will establish the role of SGI-110 in reversing the epigenetic
based resistance in patients receiving platinum based standard of care
treatment," said Mohammad Azab, MD, chief medical officer. "We are pleased to
commence investigational studies of SGI-110 in ovarian cancer with this first
ever randomized clinical trial of a DNA hypomethylating agent in combination
with platinum in platinum-resistant patients."
About the Study
The primary objective in Stage A of this Phase 2 trial is to determine the
safety and tolerability of combination therapy with SGI-110 and carboplatin and
to determine the MTD for Stage B. The primary objective in Stage B will be to
assess and compare PFS between combination therapy with SGI-110 and carboplatin
and treatment of choice arms. Secondary objectives in Stage A and Stage B
include assessment of methylation of tumor suppressor genes before and after
treatment, objective response rate, clinical benefit rate, duration of
response, CA-125 reduction, and overall survival.
Additional information about the study can be found online at
clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01696032.
About SGI-110
SGI-110 is a small molecule, DNA-hypomethyating agent with demonstrated
activity in restoring silenced tumor suppressor gene expression in cancer cells
by reversal of DNA methylation. A follow-up to the decitabine (Dacogen)
franchise, SGI-110 is also being evaluated in a first-in-human Phase 1-2
clinical trial in patients with intermediate or high-risk myelodysplastic
syndromes (MDS) and acute myeloid leukemia (AML), in collaboration with
multiple cancer centers, including clinical investigators of the Stand Up to
Cancer Epigenetics Dream Team.
SGI-110 is wholly owned by Astex Pharmaceuticals.
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel
small molecule therapeutics with a focus on oncology. The Company is developing
a proprietary pipeline of novel therapies and is creating de-risked products
for partnership with leading pharmaceutical companies. Astex Pharmaceuticals
developed Dacogen® (decitabine) for Injection and receives significant
royalties on global sales.
The Astex Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=12273
For more information about Astex Pharmaceuticals, Inc., please visit
http://www.astx.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of
Section 21A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and is subject to the safe harbor
created thereby. These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may," "should," or
similar expressions. Actual results could differ materially from those
projected in the forward-looking statements as a result of a number of risks
and uncertainties. These forward-looking statements include, but are not
limited to, expectations regarding the advancement of drug candidates in the
clinic; the Company's ability to develop the current and future pipeline into
commercially viable drugs; the expectations regarding our clinical trials
including the timing of clinical proof of concept data from these trials.
Important factors that could cause actual results to differ materially from the
expectations reflected in the forward-looking statements include, but are not
limited to: the outcomes of the on-going clinical trials; risks and
uncertainties related to the research and development of SGI-110. References
made to the discussion of risk factors are detailed in the Company's filings
with the Securities and Exchange Commission including reports on its most
recently filed Form 10-K and Form 10-Q. These forward-looking statements are
made only as of the date hereof, and we disclaim any obligation to update or
revise the information contained in any such forward-looking statements,
whether as a result of new information, future events or otherwise.
CONTACT: Timothy L. Enns
Astex Pharmaceuticals, Inc.
Senior Vice President
Corporate Communications & Marketing
Tel: +1 (925) 560-2810
E-mail:
Susanna Chau
Astex Pharmaceuticals, Inc.
Manager
Investor Relations
Tel: +1 (925) 560-2845
E-mail:
Alan Roemer
The Trout Group
Managing Director
Tel: +1 (646) 378-2945
E-mail:
Kari Watson
MacDougall Biomedical Communications
Senior Vice President
Tel: +1 (781) 235-3060
E-mail: