Study sponsored by Innsbruck Medical University in Austria and funded
by the European Commission
LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 9, 2014--
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the launch of
GANNET53, a pan-European randomized trial evaluating the combination of
ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients with
metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer.
Centers in Austria, Belgium, France, and Germany will participate in the
clinical trial, which is expected to begin enrollment in mid-2014.
Ganetespib, Synta’s lead anti-cancer drug candidate, inhibits the heat
shock protein 90 (Hsp90) chaperone protein and is being studied in over
25 clinical trials, including an ongoing Phase 3 trial in advanced
non-small cell lung cancer.
Approximately 70% of advanced ovarian cancers are characterized as Type
II tumors, which exhibit mutations in the p53 tumor suppressor gene and
are associated with particularly aggressive, rapid disease progression.
Preclinical models have shown that mutant p53 is critical to the growth
and proliferation of these cancers. Many mutations render p53 unable to
fold appropriately, leaving the protein highly dependent on Hsp90 for
stability. Inhibition of Hsp90 destroys the complex between Hsp90 and
mutant p53, leading to the degradation of the protein and cancer cell
death. This anti-cancer activity is substantially stronger in cells with
mutant p53 than in cells with non-mutated p53, suggesting potential as a
predictive biomarker for Hsp90 inhibitors such as ganetespib.
Hsp90 inhibition has also been shown to sensitize mutant p53 cancer
cells to treatment with chemotherapies, as has been seen in preclinical
studies evaluating ganetespib in other tumor types, supporting the
planned trial design evaluating the combination of ganetespib and
paclitaxel vs. paclitaxel alone.
“There is a pressing need for more effective, innovative treatment
strategies to improve survival in this group of epithelial ovarian
cancer patients,” said Professor Nicole Concin of the Innsbruck Medical
University in Austria and the GANNET53 trial Principal Investigator.
“The GANNET53 trial aims to achieve this goal by using ganetespib to
target mutant p53, which may be a central driver of ovarian cancer
aggressiveness and metastatic ability. This approach is supported by the
preclinical findings as well as encouraging clinical results for
ganetespib, including durable objective tumor responses observed with
ganetespib monotherapy in cancers with genetic profiles driven by strong
Hsp90 clients, as well as the favorable activity and safety profile
observed for the combination of ganetespib and taxanes.”
“The selection of ganetespib for the GANNET53 program and the European
Commission support are exciting steps in advancing both the science and
clinical potential of ganetespib,” said Safi R. Bahcall, Ph.D.,
President and CEO of Synta. “The identification and evaluation of the
connection between p53 mutation status and the potential role for Hsp90
inhibition, may have important implications not only for patients with
ovarian cancer, but in other tumor types for which p53 mutation is known
to be important, such as triple-negative breast cancer.”
Additional information on the ovarian cancer scientific findings and the
GANNET53 program are available at www.gannet53.eu
and at www.clinicaltrials.gov.
Additional information on the combination of ganetespib and taxanes is
available at www.syntapharma.com.
Synta has established over 100 academic, preclinical collaborations
investigating the science and potential applications of ganetespib. Over
two dozen clinical trials sponsored by investigators, cooperative
groups, or patient foundations are ongoing or planned for 2014.
About Ovarian Cancer
Each year, approximately 230,000 new cases of ovarian cancer are
diagnosed worldwide. Ovarian cancer is the most deadly of the
gynecologic cancers, causing approximately 140,000 deaths worldwide each
year, including 41,900 deaths in Europe and 14,000 deaths in the US. The
serous ovarian cancer subtype, a particularly aggressive form driven by
mutations of p53 (an Hsp90 client protein), makes up 75 to 80% of
diagnoses, with approximately 70% of these cases diagnosed in stage III
or IV. Platinum-based chemotherapy remains the mainstay of therapy and
results in a 5-year survival rate of only 30% and 10% for stages III and
IV, respectively.
About GANNET53
GANNET53 (Ganetespib in metastatic, p53 mutant, platinum-resistant
ovarian cancer) is a Seventh Framework Programme for Research (FP7)
project sponsored by the Innsbruck Medical University and funded by the
European Commission. This pan-European, multi-center trial is designed
to determine the efficacy of ganetespib and paclitaxel compared to
paclitaxel alone in patients with metastatic, Type II,
platinum-resistant ovarian cancer, which is characterized by mutations
in the p53 gene. The GANNET53 trial is the result of a preclinical
research collaboration between members of the European consortium
conducting the study and Synta. For additional information, please visit www.gannet53.eu.
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, PDFGR, 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 a biopharmaceutical company focused on
discovering, developing, and commercializing small molecule drugs to
extend and enhance the lives of patients with severe medical conditions,
including cancer and chronic inflammatory diseases. Synta has a unique
chemical compound library, an integrated discovery engine, and a diverse
pipeline of clinical- and preclinical-stage drug candidates with
distinct mechanisms of action and novel chemical structures. All Synta
drug candidates were invented by Synta scientists using our compound
library and discovery capabilities. 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 enrollment of the GANNET53 trial,
reflect our 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, 2012 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.
Source: Synta Pharmaceuticals Corp.
Investors:
Synta Pharmaceuticals Corp.
Mindy Kohl,
781-541-7213
mkohl@syntapharma.com
or
Argot
Partners
Andrea Rabney, 212-600-1494
andrea@argotpartners.com
or
Media:
Argot
Partners
Eliza Schleifstein, 917-763-8106
eliza@argotpartners.com
