DGAP-News: Astex Pharmaceuticals Announces Initiation of AT13387 Phase 2 Study in Non-Small Cell Lung Cancer
(firmenpresse) - Astex Pharmaceuticals, Inc.
24.10.2012 12:00
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DUBLIN, Calif., 2012-10-24 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 an open label, randomized, controlled,
multi-center, Phase 2 clinical trial, evaluating HSP90 inhibitor AT13387 in
anaplastic lymphoma kinase positive (ALK +) non-small cell lung cancer patients
or other potentially crizotinib-sensitive NSCLC patients who have been
receiving crizotinib. The trial will evaluate AT13387 as both single agent and
in combination with crizotinib in these patients.
The AT13387 study will consist of three parts. Part A is a lead-in, single arm,
dose escalation segment of the trial in patients with NSCLC who have already
been receiving crizotinib, to establish the Maximum Tolerated Dose (MTD) of the
combination. Once the MTD is defined in Part A, and depending on the patient's
response to crizotinib, Parts B and C will ensue in which patients will be
randomized to continue to receive crizotinib alone, AT13387 alone, or the
combination of AT13387 with crizotinib.
'This is the most comprehensive study designed to date to investigate the
efficacy and safety of an HSP90 inhibitor in patients who are sensitive to an
ALK+ inhibitor,' said Mohammad Azab, MD, chief medical officer. 'The study will
permit us to identify a clear role of HSP90 inhibition by AT13387 both as a
single agent and in combination with an ALK+ inhibitor in the treatment of
NSCLC.'
About the Study
The primary objective of Part A of this trial is to determine the safety and
tolerability of combination therapy with AT13387 and crizotinib and to
determine the MTD for Parts B and C. The primary objective in Part B will be to
compare the efficacy by response rate between continued administration of
single agent crizotinib versus the combination of AT13387 plus crizotinib in
patients who were treated for at least 8 weeks with crizotinib and have not yet
progressed. Lastly, the primary objective of Part C will be to test the
efficacy by response rate of single agent AT13387 and the combination of
AT13387 and crizotinib in patients who progressed on treatment with crizotinib.
Additional information about the study can be found online at
clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01712217
About AT13387
AT13387 is a small molecule inhibitor of HSP90, a heat shock protein believed
to be responsible for supporting the development of cancer in many tumor cells.
HSP90 acts as a 'molecular chaperone,' stabilizing and preventing the breakdown
of key oncogenic proteins. These client proteins, including HER2 (the target
for Herceptin(r) in the treatment of breast cancer), androgen (the target for
Zytiga(r) in prostate cancer), mutant B-raf (the target for Zelboraf(r) in
melanoma), ALK (the target for Xalkori(r) in lung cancer), c-kit (the target for
Gleevec(r) in gastrointestinal tumors) and mutant EGFr (the target for Tarceva(r)
and Iressa(r) in the treatment of non-small cell lung cancers) are associated
with different tumor types.
Although AT13387 is a targeted inhibitor of HSP90, it has the potential to
control the proliferation of multiple solid tumors and hematological
malignancies where uncontrolled cell growth is dependent on the interaction
between HSP90 and its client proteins. These include tumor types that have
become resistant to initial therapy.
Astex Pharmaceuticals has an ongoing Phase 2 study in patients with refractory
gastrointestinal stromal tumors (GIST) and a Phase 2 trial in patients with
castration-resistant prostate cancer (CRPC) who are no longer responding to
treatment with the standard of care therapies, abiraterone acetate and
steroids.
In November 2009, Astex Pharmaceuticals entered into a CRADA with the US
National Cancer Institute (NCI) to support the further clinical development of
AT13387 over the next 5 years. The CRADA will enable a number of single agent
and combination Phase 1/2a and Phase 2 studies.
AT13387, a proprietary compound, 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(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 AT13387. 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.
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
Kari Watson
MacDougall Biomedical Communications
Senior Vice President
Tel: +1 (781) 235-3060
E-mail: kwatson(at)macbiocom.com
News Source: NASDAQ OMX
24.10.2012 Dissemination of a Corporate News, transmitted by DGAP -
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The issuer is solely responsible for thecontent of this announcement.
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Language: English
Company: Astex Pharmaceuticals, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US04624B1035
WKN:
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