DGAP-News: Astex Pharmaceuticals Announces Oral Presentation of SGI-110 Results From Phase 1/2 MDS and AML Study at ASH
(firmenpresse) - Astex Pharmaceuticals, Inc.
20.11.2012 12:01
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DUBLIN, Calif., 2012-11-20 12:00 CET (GLOBE NEWSWIRE) --
Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated
to the discovery and development of novel small molecule therapeutics,
announced that results from the dose escalation part of a randomized Phase 1/2
first-in-human clinical trial of subcutaneous SGI-110, a novel hypomethylating
agent, in patients with relapsed/refractory intermediate or high-risk
myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML) will be
presented during the American Society of Hematology (ASH) Annual Meeting in
Atlanta, Georgia on Monday, December 10, 2012 at 11:45 am ET. The oral
presentation will be made by Hagop M. Kantarjian, MD, professor and department
chair, department of leukemia, cancer medicine division, The University of
Texas MD Anderson Cancer Center, Houston, TX. The accepted abstract is
available on the ASH website at:
https://ash.confex.com/ash/2012/webprogram/Paper49626.html
The dose escalation part of the study demonstrated that SGI-110 is well
tolerated at doses higher than the biologically effective dose (BED);
subcutaneous (SQ) administration achieved efficient conversion to decitabine
resulting in an improved pharmacokinetic (PK) profile over intravenous (IV)
Dacogen formulation; and clinical responses were observed in this heavily
pretreated population which seem to correlate with the extent of LINE-1
hypomethylation.
'Following the preliminary presentation at AACR, this is the second oral
presentation of clinical data for SGI-110 this year in which the full data set
of the phase 1 part of the trial will be discussed. We are pleased with the
progress of SGI-110 in the treatment of these difficult to treat hematological
malignancies,' said Mohammad Azab, MD, chief medical officer of Astex
Pharmaceuticals.
Additionally, a preclinical data presentation on SGI-110 titled, 'SGI-110, a
novel hypomethylating agent, induces the WNT inhibitor Secreted Frizzled
Related Protein-2 (SFRP2), and down regulates beta-catenin in acute myeloid
leukemia (AML) cells,' will occur in a poster session on Saturday, December 8,
2012 from 5:30 - 7:30 pm ET.
About the Study
The SGI-110 study enrolled 78 patients (64 AML, 14 MDS), in the dose escalation
part of this randomized Phase 1/2 first-in-human trial with 44 patients
receiving drug daily for 5 days (dailyx5 regimen) and 34 patients receiving
drug once weekly for 3 consecutive weeks (weeklyx3 regimen). Median age was 69
years, and 82% had ECOG PS of 0-1. Median number of prior regimens was 3 (range
1-9), 59% of patients had prior hypomethylation agent (HMA) treatment (50% of
AML patients, and 100% of MDS patients). Clinical responses were observed in
this heavily pretreated AML and MDS patients.
The study has progressed to the dose expansion part and is actively accruing
patients.
A copy of the 2012 ASH presentation, 'Results From the Dose Escalation Phase of
a Randomized Phase 1-2 First-in-Human (FIH) Study of SGI-110, a Novel Low
Volume Stable Subcutaneous (SQ) Second Generation Hypomethylating Agent (HMA)
in Patients with Relapsed/Refractory MDS and AML,' will be available following
the conclusion of the oral presentation on the Astex Pharmaceuticals website,
www.astx.com, in the pipeline, presentations and publications section.
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(r) (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: tim.enns(at)astx.com
Susanna Chau
Astex Pharmaceuticals, Inc.
Manager
Investor Relations
Tel: +1 (925) 560-2845
E-mail: susanna.chau(at)astx.com
Alan Roemer
The Trout Group
Managing Director
Tel: +1 (646) 378-2945
E-mail: aroemer(at)troutgroup.com
Kari Watson
MacDougall Biomedical Communications
Senior Vice President
Tel: +1 (781) 235-3060
E-mail: kwatson(at)macbiocom.com
Company Logo
News Source: NASDAQ OMX
20.11.2012 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Astex Pharmaceuticals, Inc.
United States
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ISIN: US04624B1035
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