Company to Host Conference Call on Wednesday, October 21 at 8:00
AM ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 20, 2015--
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the
Company has decided to terminate the Phase 3 GALAXY-2 trial of
ganetespib and docetaxel in the second-line treatment of patients with
advanced non-small cell lung adenocarcinoma. Based on the review of a
pre-planned interim analysis, the study’s Independent Data Monitoring
Committee (IDMC) concluded that the addition of ganetespib to docetaxel
is unlikely to demonstrate a statistically significant improvement in
the primary endpoint of overall survival compared to docetaxel alone.
The IDMC noted that the combination of ganetespib and docetaxel was
generally well tolerated in the study, with an adverse event profile
consistent with previous studies combining these agents.
GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta
continues to support enrollment in four additional large, randomized,
multi-center investigator-sponsored studies, including: the GANNET53
trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial
of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia
(AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of
ganetespib with standard DA (daunorubicin and Ara-C) in AML and
high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard
chemotherapy in women with newly diagnosed, locally advanced breast
cancer.
“This disappointing outcome underscores the challenges of treating lung
cancer in the second-line setting and determining the precise population
for whom ganetespib may be most effective,” said Chen Schor, President
and Chief Executive Officer of Synta. “We thank the patients, caregivers
and investigators who participated in GALAXY-2.”
Mr. Schor continued: “Despite the outcome of this trial, and pending
discussions with the relevant investigators, we will continue to support
ongoing investigator-sponsored studies while we determine the
appropriate path forward for ganetespib. We also look forward to
advancing candidates from our HDC platform into the clinic. With the
significant cash reserves we have in hand, our pipeline, our scientific
internal leadership and network of advisors, we expect to undertake a
comprehensive review of our strategy going forward.”
Upon formal acceptance of the IDMC’s recommendation, Synta will
communicate with regulatory authorities, and will notify study
investigators that treatment with ganetespib should be discontinued in
the GALAXY-2 trial.
Conference call
Synta will host a conference call at 8:00 AM ET on Wednesday, October
21st to discuss the outcome of the GALAXY-2 trial. The conference call
will be webcast live and can be accessed by logging on to the
“Investors” section of the Synta Pharmaceuticals website, www.syntapharma.com,
prior to the event.
The conference call can also be accessed by dialing (877) 715-8365
(U.S.) or (440) 996-5675 (International). For those unable to join the
live call, a replay will be available from 11:00 a.m. ET on October 21
through 11:59 p.m. ET on October 28. To access the replay, please dial
(855) 859-2056 (U.S.) or (404) 537-3406 (International) and refer to
conference ID 65923441.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is an innovative, agile biopharmaceutical
company focused on research, development and commercialization of novel
oncology medicines that have the potential to change the lives of cancer
patients. Synta’s lead oncology drug candidate, ganetespib, a novel heat
shock protein 90 (Hsp90) inhibitor, is currently being evaluated in
several investigator sponsored clinical trials including clinical trials
in acute myeloid leukemia (AML), ovarian cancer, breast cancer, and
other tumor types. Building on its extensive expertise in the science of
Hsp90, Synta also has a novel proprietary Hsp90 inhibitor Drug Conjugate
(HDC) small molecule drug development program. IND enabling studies have
commenced for the first clinical candidate from the HDC program,
STA-12-8666, and preclinical evaluation of additional HDC candidates is
ongoing. For more information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about Synta
Pharmaceuticals Corp. Such forward-looking statements can be identified
by the use of forward-looking terminology such as "will", "would",
"should", "expects", "anticipates", "intends", "plans", "believes",
"may", "estimates", "predicts", "projects", or similar expressions
intended to identify forward-looking statements. Such statements,
including statements relating to the continuation of the ongoing
investigator-sponsored studies of ganetespib and the advancement of
candidates from our HDC platform toward the clinic, reflect Synta’s
current views with respect to future events and are based on assumptions
and subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
forward-looking statements, including those described in "Risk Factors"
of our Form 10-K for the year ended December 31, 2014 as filed with the
Securities and Exchange Commission. Synta undertakes no obligation to
publicly update forward-looking statements, whether because of new
information, future events or otherwise, except as required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151020006900/en/
Source: Synta Pharmaceuticals Corp.
Investors:
Synta Pharmaceuticals Corp.
Daniel Cole,
781-541-7250
[email protected]
or
Argot
Partners
Andrea Rabney or Susie Kim, 212-600-1902
[email protected]
or
Media:
Argot
Partners
Eliza Schleifstein, 917-763-8106
[email protected]
