Astex Pharmaceuticals Announces IND Candidate: ASTX727 a Potential
Best-in-Class Oral Hypomethylator
Investigational New Drug (IND) Application and Data Presentations Planned for
the Fourth Quarter
DUBLIN, Calif., July 8, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc.
(Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and
development of novel small molecule therapeutics, announced today its plan to
submit an Investigational New Drug or IND application to the Food and Drug
Administration (FDA) for ASTX727, a novel oral hypomethylating agent (HMA) in
the fourth quarter of this year.
ASTX727 is intended as a fixed dose oral combination product consisting of
decitabine and E7727, a novel cytidine deaminase inhibitor (CDAi) licensed
from Eisai Inc. ASTX727 allows for an efficient oral delivery of decitabine at
low doses.Relevant animal studies revealed that the product can result in
therapeutic exposures of decitabine at low doses.The profile of E7727 is
expected to result in low inter-patient variability across doses of decitabine
with little or no gastrointestinal safety issues. Later this year,
preclinical data on ASTX727 will be submitted for presentation at a scientific
"We are pleased to announce that ASTX727, in the late pre-clinical stage of
development, becomes the third product in our epigenetic franchise that began
with DACOGEN® (decitabine) for Injection.This franchise includes SGI-110,
expected to enter Phase III clinical trials in 2014," commented James S.J.
Manuso, Ph.D., Astex Pharmaceuticals chief executive officer and
chairman."The role of HMAs, in a wide range of therapeutic indications, is
just beginning to be understood. ASTX727, potentially a best-in-class oral
HMA, will be an important addition to our portfolio of medicines in clinical
Cytidine deaminase (CDA) is an enzyme that is responsible for the degradation
of nucleosides, including decitabine and azacitidine.High levels of CDA in
the gastrointestinal tract and liver rapidly degrade these nucleosides and
prohibit or limit their oral bioavailability. E7727 is a proprietary and
patented New Molecular Entity (NME) with a very wide therapeutic margin that
inhibits CDA activity.Decitabine can be delivered orally and efficiently
absorbed in the gut when it is combined with E7727 due to the inhibition of
CDA by E7727.ASTX727 is being developed as a fixed dose oral product that
combines E7727 and decitabine. This oral HMA with the potential to be
best-in-class will enter clinical development in 2014. Astex has a worldwide
license to E7727 from Eisai Inc.
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 and out-licensed DACOGEN® (decitabine) for Injection
and receives significant royalties on global sales.
For more information about Astex Pharmaceuticals, Inc., please visit
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 ASTX727.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
Astex Pharmaceuticals, Inc.
Tel: +1 (925) 560-2845
The Trout Group
Tel: +1 (646) 378-2945
Astex Pharmaceuticals, Inc. logo
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