First Patient Enrolled in Phase 2 Portion of
GANNET53 Study of Ganetespib in Ovarian Cancer
Phase 2 GALAXY-1 Trial of Ganetespib in
NSCLC Published in Annals of Oncology
Synta Pharmaceuticals Corp. (NASDAQ:SNTA) today announced
updates to its clinical program for Ganetespib, a next-generation
inhibitor of the chaperone protein Hsp90. Ganetespib is currently
being studied in several large, randomized studies, including the
Phase 3 GALAXY-2 trial in non-small cell lung cancer, as well as a
number of other investigator-sponsored studies in various
malignancies, including acute myeloid leukemia, breast cancer and
ovarian cancer.
The Company announced today that the first patient has been
enrolled in the Phase 2 portion of the GANNET53 study, a
randomized, pan-European study evaluating the combination of
ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients
with metastatic, predominantly p53 mutant, platinum-resistant
ovarian cancer. Enrollment in the Phase 2 portion follows the
successful completion of Phase 1, the results of which were
recently presented at the 2015 American Society of Clinical
Oncology Annual Meeting in Chicago. The Phase 1 data demonstrated
that the combination of ganetespib 150 mg/m² with paclitaxel 80
mg/m² once weekly for 3 out of 4 weeks was generally well
tolerated, with no dose limiting toxicities, and was therefore
chosen for the randomized phase 2 trial. GANNET53 is sponsored by
Innsbruck Medical University in Austria and funded by the European
Commission.
“The Phase 1 portion of GANNET53 has established the feasibility
and tolerability of combining ganetespib and paclitaxel, and we
eagerly look forward to the enrollment of, and results from the
randomized Phase 2 portion of this trial.” said Professor Nicole
Concin of the Innsbruck Medical University in Austria and the
GANNET53 trial Principal Investigator. “We are very excited about a
recent scientific insight into the relationship of p53
gain-of-function mutations which are the molecular hallmark of
aggressive, high-grade serous ovarian carcinoma, and Hsp90
inhibition leading to tumor cell death in vitro and significant
tumor control and prolonged survival in a novel p53 mutant mouse
model. This unique mechanism of action and encouraging preclinical
data support our choice of the ganetespib combination in an effort
to optimize treatment for women with platinum-resistant ovarian
cancer.”
The Company also announced today that results from the Phase 2
GALAXY-1 trial, a global, randomized, multi-center study designed
to identify the patients with advanced non-small cell lung cancer
(NSCLC) most likely to benefit from second-line treatment with
ganetespib in combination with docetaxel versus docetaxel alone,
have been published in the journal Annals of Oncology. As
previously announced, a pre-specified stratification factor
analysis demonstrated that patients diagnosed with advanced
non-small cell lung adenocarcinoma more than six months prior to
study entry derived the most benefit from combination treatment,
leading to the selection of this population for the ongoing Phase 3
GALAXY-2 trial. Based on current projections and statistical
assumptions, the first interim overall survival (OS) analysis of
GALAXY-2 is on track to occur in the second half of 2015, and the
second interim and final OS analyses will be conducted in 2016. The
GALAXY-1 publication is available online here.
“We are pleased to see the GALAXY-1 findings published in the
Annals of Oncology and look forward to understanding how outcomes
from this trial translate to the ongoing, pivotal Phase 3 GALAXY-2
trial,” said Dr. Suresh Ramalingam, M.D., Professor, Hematology
& Medical Oncology, and Director, Division of Medical Oncology,
of the Winship Cancer Institute of Emory University, and a
principal investigator of the GALAXY program. “Ganetespib’s unique
mechanism of action has the potential to play an important role in
the evolving treatment landscape in lung cancer. I look forward to
the outcome of GALAXY-2.”
“We remain highly encouraged by the progress of the ganetespib
program across a broad spectrum of malignancies and grateful to our
collaborating investigators for their strong, ongoing support for
what is today the most advanced, next generation inhibitor of
Hsp90,” said Chen Schor, President and Chief Executive Officer of
Synta. “We look forward to several transformative milestones on the
horizon, both for ganetespib and our lead HDC candidate,
STA-12-8666.”
About Ganetespib
Ganetespib, an investigational drug candidate, is a selective
inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone
which controls the folding and activation of a number of client
proteins that drive tumor development and progression. Many solid
and hematologic tumors are dependent on Hsp90 client proteins
including proteins involved in “oncogene addiction” (ALK, HER2,
mutant BRAF and EGFR, androgen receptor, estrogen receptor, and
JAK2); proteins involved in resistance to chemotherapy and
radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1, survivin, and
WEE1); proteins involved in angiogenesis (HIF-1alpha, VEGFR, PDGFR,
and VEGF); and proteins involved in metastasis (MET, RAF, AKT,
MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of
Hsp90 by ganetespib results in the inactivation, destabilization,
and eventual degradation of these cancer-promoting proteins.
Ganetespib is being evaluated in trials in lung cancer, breast
cancer, and other tumor types. The most common adverse event seen
to date has been transient, mild or moderate diarrhea, which has
been manageable with standard supportive care. Information on these
trials can be found at www.clinicaltrials.gov. Ganetespib has
received Fast Track designation from FDA for second-line treatment
of non-small cell lung adenocarcinoma in combination with
docetaxel.
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 clinical
trials including the pivotal GALAXY-2 Phase 3 trial in non-small
cell lung cancer. 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
relationship between p53 mutations and Hsp90 inhibition, the
potential role of ganetespib in the evolving lung cancer treatment
landscape, upcoming transformative milestones for ganetespib and
STA-12-8666 and the anticipated timing for the interim and final
analyses from the GALAXY-2 trial, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150602006185/en/
Investors:Synta Pharmaceuticals Corp.Daniel Cole,
781-541-7250dcole@syntapharma.comorArgot PartnersAndrea Rabney,
212-600-1494andrea@argotpartners.comorMedia:Argot
PartnersEliza Schleifstein, 917-763-8106eliza@argotpartners.com
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