DGAP-News: Astex Pharmaceuticals Announces Initiation of the Phase 2 Expansion of the SGI-110 Clinical Trial in MDS and AML Patients
(firmenpresse) - Astex Pharmaceuticals, Inc.
22.06.2012 12:00
---------------------------------------------------------------------------
DUBLIN, Calif., 2012-06-22 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 the Phase 2 dose expansion segment of the
clinical trial of SGI-110, a novel hypomethylating agent, in patients with
intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid
leukemia (AML). Treatment-naive MDS and elderly AML (>=65 years) will be
enrolled in the dose expansion.
Enrollment in the Phase 2 segment is currently open, and the first patient has
been dosed. The Phase 2 segment includes expansion of the number of patients to
approximately 90 patients treated on the five day subcutaneous dosing schedule
to better evaluate both efficacy and safety in MDS and AML patients.
'The initiation of SGI-110's Phase 2 expansion of the clinical trial marks an
important milestone for our company as we advance the development of our
second-generation hypomethylating agent,' said James S.J. Manuso, PhD, chairman&chief executive officer.
'We are pleased with the advancement of SGI-110 into the Phase 2 segment of the
clinical trial. The allowance of treatment-naive MDS and elderly AML patients
will be important in evaluating efficacy and safety of SGI-110 in this patient
population and to further characterize the clinical differentiation of the
drug,' said Mohammad Azab, MD, chief medical officer.
Interim Phase 1 clinical data from subcutaneous SGI-110 was previously reported
at the American Association for Cancer Research (AACR) 2012 Annual Meeting in
Chicago, IL. The data showed that SGI-110 has a clear pharmacokinetic
differentiation from Dacogen(r) (decitabine) for Injection given as an IV
infusion. The drug achieved excellent hypomethylation, and major clinical
responses in heavily pre-treated AML patients were observed.
Solid tumor Phase 2 trials of SGI-110 are expected to begin before the end of
2012.
Stand Up To Cancer (SU2C) has provided funding for the Epigenetics Dream Team
that is collaborating on the scientific evaluation of SGI-110.
About the Study
The primary objective in the dose expansion segment will be estimating overall
remission rates. Secondary objectives include estimating the incidence and
severity of dose limiting toxicity (DLT), the PK profile of SGI-110 and
decitabine, rates of hematologic improvement and duration of remission, time to
disease progression, overall survival rate, and incidence of blood and platelet
transfusions.
A copy of the 2012 AACR oral presentation, 'Interim results from a randomized
Phase 1-2 first-in-human-(FIH) study of PK/PD guided escalating doses of
SGI-110, a novel subcutaneous (SQ) second generation hypomethylating agent
(HMA) in relapsed/refractory MDS and AML' is available in the pipeline,
presentations and publications section of the Astex Pharmaceuticals website,
www.astx.com.
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-riskedproducts
for partnership with leading pharmaceutical companies. Astex Pharmaceuticals
developed Dacogen(r) (decitabine) for Injection and receives significant
royalties on global sales.
For more information about Astex Pharmaceuticals, Inc., please visit
http://www.astx.com.
The Astex Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=12273
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: tim.enns(at)astx.com
Alan Roemer
The Trout Group
Managing Director
Tel: +1 (646) 378-2945
E-mail: aroemer(at)troutgroup.com
Susanna Chau
Astex Pharmaceuticals, Inc.
Manager
Investor Relations
Tel: +1 (925) 560-2845
E-mail: susanna.chau(at)astx.com
Melanie Toyne-Sewell (Europe)
Rebecca Skye Dietrich (US)
College Hill
Tel: +44 20 7866 7866
Tel: +1 (857) 241-0795
E-mail: astex(at)collegehill.com
News Source: NASDAQ OMX
22.06.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Astex Pharmaceuticals, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US04624B1035
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Themen in dieser Pressemitteilung:
astex-pharmaceuticals-announces-initiation-of-the-phase-2-expansion-of-the-sgi
110-clinical-trial-in-mds-and-aml-patients
Unternehmensinformation / Kurzprofil:
Datum: 22.06.2012 - 12:00 Uhr
Sprache: Deutsch
News-ID 159045
Anzahl Zeichen: 1454
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 287 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Astex Pharmaceuticals Announces Initiation of the Phase 2 Expansion of the SGI-110 Clinical Trial in MDS and AML Patients"
steht unter der journalistisch-redaktionellen Verantwortung von
Astex Pharmaceuticals, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
