Astex Pharmaceuticals Announces Subcutaneous SGI-110 Interim Phase 1/2 MDS and AML Data Presentation at AACR
DUBLIN, Calif., April 3, 2012 – Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that interim Phase 1/2 clinical data from subcutaneous SGI-110, a novel hypomethylating agent, demonstrated differentiated PK profile, good tolerability, and preliminary promising complete responses in heavily pretreated acute myelogenous leukemia (AML) patients enrolled in the Phase 1 segment of the trial.? The data was presented at an oral session at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL and was featured in a joint AACR-Stand Up To Cancer (SU2C) media forum.? SU2C has provided funding for the Epigenetics Dream Team that is collaborating on the scientific evaluation of SGI-110.
The randomized Phase 1/2 first-in-human dose escalation study
enrolled 66 patients with previously treated intermediate or
high-risk myelodysplastic syndromes (MDS) or AML as of March 28,
2012.? Of seven evaluable refractory AML patients who had adequate
hypomethylation with no prior resistance to hypomethylating agents
(HMAs), two showed complete response, and one showed partial
response.? Additionally, the pharmacokinetic (PK) data suggests
delivery of decitabine by SGI-110 achieves high decitabine exposure
and longer half-life than decitabine intravenous (IV) infusion.?
The pharmacodynamic (PD) data shows potent dose-dependent
hypomethylation induction in the daily regimen.
"This interim SGI-110 data is very encouraging for refractory AML
patients," said Jean-Pierre Issa, MD, professor of medicine and
director of the Fels Institute for Cancer Research and Molecular
Biology at Temple University.? "With the optimal biologically
effective dose reached, this provides a firm basis to begin the
dose expansion segment of the trial for treatment of elderly AML
and previously untreated MDS."
"This is a great example of collaboration between SU2C and
industry," said Stephen B. Baylin, MD, professor of oncology and
medicine, deputy director of the Sidney Kimmel Comprehensive Cancer
Center at Johns Hopkins; co-leader of the Epigenetics Dream Team of
SU2C.? "The trial used a biologically driven design where dose
escalation was based on biological efficacy of the drug and not
just toxicities as is often the case with cancer drugs.? Achieving
clinical efficacy at the biologically effective doses is a
validation of this innovative design."
About the Study
The primary objective in the dose escalation segment was to
estimate the optimal biologically effective dose (BED) and/or the
maximum tolerated dose (MTD).? 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.? The PD studies
suggest the optimal BED was reached prior to the MTD.
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-risked products for partnership with leading pharmaceutical companies.? Astex Pharmaceuticals developed Dacogen® (decitabine) for Injection and receives significant royalties on global sales.
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.
Contacts:
Timothy L. Enns
Astex Pharmaceuticals, Inc.
Senior Vice President
Corporate Communications & Marketing
Tel:? (925) 560-2810
E-mail:? tim.enns@astx.com
Susanna Chau
Astex Pharmaceuticals, Inc.
Manager
Investor Relations
Tel:? (925) 560-2845
E-mail:? susanna.chau@astx.com
Alan Roemer
The Trout Group
Managing Director
Tel:? (646) 378-2945
E-mail: aroemer@troutgroup.com
Melanie Toyne-Sewell (Europe)
Rebecca Skye Dietrich (US)
College Hill
Tel: +44 20 7866 7866
Tel: (857) 241-0795
E-mail: astex@collegehill.com
Posted: April 2012
