SGX Pharmaceuticals, Inc.
(Nasdaq: SGXP) announced today that it has discontinued the Phase II/III
clinical trial of Troxatyl(TM) as a third-line treatment for patients
suffering from acute myelogenous leukemia (AML), based upon the
recommendation of the study's independent data and safety monitoring board
(DSMB). The DSMB found that the study response rates were unlikely to
provide evidence of a treatment benefit as a third-line treatment for
patients with AML. The recommendation to discontinue the clinical trial was
not made due to safety concerns.
"The response rates observed to date in our Phase II/III trial of
Troxatyl are not at a level that we believe would support a New Drug
Application as a third-line treatment for AML and we feel it is appropriate
to follow the recommendation of the DSMB to discontinue this trial," said
Mike Grey, president and chief executive officer of SGX Pharmaceuticals.
"Although we are disappointed with the results of Troxatyl in this very
difficult to treat third-line AML population, Troxatyl has produced
interesting clinical results in other indications and we remain optimistic
for its potential in these other indications. We will now analyze data from
all patients treated thus far in the Phase II/III trial and will be taking
a careful look at the range of opportunities to determine an appropriate
development path for Troxatyl."
Grey added, "We remain enthusiastic about our pipeline and our
proprietary drug discovery platform, FAST(TM). We expect to identify a
development candidate later this year, with a targeted IND filing in the
first half of 2007, in our BCR-ABL inhibitor program in collaboration with
Novartis for the treatment of drug resistant chronic myelogenous leukemia,
which is our most advanced program developed using our FAST drug discovery
platform."
About Third-Line Acute Myelogenous Leukemia and the Phase II/III Trial
The Phase II/III trial was designed to establish the safety and
effectiveness of Troxatyl in patients with relapsed or refractory AML.
Patients targeted in this study are those who are in a second relapse with
duration of second response less than six months, or who were refractory to
two previous courses of induction chemotherapy. A DSMB was instituted prior
to the study's commencement to periodically review safety and efficacy data
and make recommendations about study conduct. The study was designed to
demonstrate a meaningful improvement over the historical data from the M.D.
Anderson Cancer Center database which documented a complete response rate
of 4.7 percent in this patient subgroup. The observed response rates in the
Phase II/III trial to date did not show a meaningful improvement over the
response rates in the M.D. Anderson Cancer Center historical database.
There currently are no approved therapies for treating third-line adult AML
patients and the historical median survival time is approximately two
months.
Webcast of Conference Call
SGX Pharmaceuticals will host a conference call today at 6:30 p.m.
Eastern Daylight Time to discuss the discontinuation of the Troxatyl Phase
II/III trial as a third-line treatment for patients with AML. A live
webcast will be available through the investor relations section of the SGX
website at sgxpharma. Alternatively, investors may participate in
the conference call by dialing 800-573-4842 (domestic), or 617-224-4327
(international), and using the passcode 54018267. A telephone replay will
also be available approximately one hour after completion of the call. To
access the telephone replay, dial 888-286-8010 (domestic), or 617-801-6888
(international), and use the passcode 11186182. The webcast and telephone
replay will be available through September 5, 2006.
About SGX Pharmaceuticals
SGX Pharmaceuticals is a biotechnology company focused on the
discovery, development and commercialization of innovative cancer
therapeutics. SGX's oncology pipeline includes Troxatyl and drug candidates
based on its enabling, proprietary FAST(TM) drug discovery platform,
including a next generation BCR-ABL inhibitor currently being developed in
partnership with Novartis. FAST allows for the rapid identification of
novel, potent and selective small molecule compounds for well validated but
challenging targets. More information on the pipeline and drug discovery
platform can be found at sgxpharma.
Safe Harbor Statement
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include, but are
not limited to, statements related to the therapeutic potential of Troxatyl
in AML and other indications, future plans, activities and expectations
regarding Troxatyl development and the BCR-ABL program, and the
effectiveness and efficiency of the FAST technology to generate novel lead
molecules for therapeutic targets. These statements are only predictions
based on current information and expectations and involve a number of risks
and uncertainties. Actual events or results may differ materially from
those projected in any of such statements due to various factors, including
the risks and uncertainties inherent in drug discovery, development and
commercialization, collaborations with others, and litigation. In
particular, the results of early clinical trials may not be predictive of
future results, and SGX cannot provide any assurances that it will continue
development of Troxatyl for any indication or that any of its product
candidates will have favorable results in future clinical trials or receive
regulatory approval. In addition, results may be affected by risks that the
required regulatory approvals will be received in a timely manner, or at
all, risks related to the implementation of its collaborations, competition
from other biotechnology and pharmaceutical companies, its effectiveness at
managing its financial resources, the level of efforts that its
collaborative partners devote to development and commercialization of its
product candidates, difficulties or delays in or suspension or termination
of its clinical trials, the scope and validity of patent protection for its
product candidates, regulatory developments involving future products and
its ability to obtain additional funding to support its operations. For a
discussion of these and other factors, please refer to the risk factors
described in the Company's annual report on Form 10-K for the year ended
December 31, 2005, the Company's quarterly report on Form 10-Q for the
quarter ended June 30, 2006 as well as other subsequent filings with the
Securities and Exchange Commission. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All forward-looking
statements are qualified in their entirety by this cautionary statement and
SGX undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof.
SGX Pharmaceuticals, Inc.
sgxpharma