LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 5, 2014--
Synta Pharmaceuticals Corp. (NASDAQ:SNTA) today announced that the
Company has been invited by the U.S. Food and Drug Administration (FDA)
to participate in a meeting of the Oncologic Drugs Advisory Committee’s
(ODAC) Pediatric Subcommittee on December 11, 2014. The purpose of the
meeting is to inform the FDA as to whether there is sufficient interest
in the pediatric investigator community to warrant the FDA issuing a
Pediatric Written Request to Synta. If the FDA issues a Pediatric
Written Request and Synta fulfills its requirements, an additional six
months of exclusivity will be granted to ganetespib. At the
meeting, the subcommittee will review the SARC 023 study, investigating
ganetespib in patients with malignant peripheral nerve sheath tumors
(MPNSTs) and other sarcomas. Ganetespib is a next-generation inhibitor
of the chaperone protein Hsp90, which is critical for the activation and
stability of numerous proteins that control malignant tumor growth.
Ganetespib has been studied in over 1,200 adult patients to date.
SARC 023, sponsored by the Sarcoma Alliance for Research through
Collaboration (SARC), is an open label Phase 1/2 trial of ganetespib in
combination with the mTOR inhibitor sirolimus in patients with
refractory sarcoma, including MPNST. The Principal and Co-Principal
Investigators are AeRang Kim, MD, PhD, of the Children’s National
Medical Center and Brigitte Widemann, MD, Section Head, National Cancer
Institute Pediatric Oncology Branch. The Pediatric Subcommittee of ODAC
will review the design of SARC 023, as well as pre-clinical data
demonstrating the scientific rationale for studying this combination in
a clinical trial.
The Phase 1 portion of the study, which is currently ongoing, is
designed to assess the safety, tolerability, and maximum
tolerated/recommended dose of the combination in patients ≥ 18 years of
age (to be amended to ≥ 16 years of age) with refractory sarcomas or
unresectable or metastatic sporadic or neurofibromatosis type-1
associated MPNST. Upon determination of the recommended dosing, the
primary objective of the phase 2 portion will be to determine the
clinical benefit rate (CR, PR, or stable disease ≥ 4 months using WHO
criteria) of the combination in patients with refractory MPNST.
Secondary objectives include determination of the pharmacokinetic
profile of these agents in combination and pharmacodynamic markers in
tumor tissue and peripheral blood mononuclear cells, patient reported
pain outcomes, and volumetric MRI analysis of tumor measurement. For
additional information, click here.
“Outcomes for unresectable, recurrent, or metastatic MPNST are very
poor, underscoring an urgent need for new therapeutic options,” said Dr.
Vojo Vukovic, Chief Medical Officer, Synta. “Drugs that target Hsp90 and
mTOR have shown synergistic activity in MPNST animal models. If the
combination proves safe and effective in patients, it may provide an
important new therapeutic strategy for this disease. We look forward to
discussing the current clinical experience with ganetespib as well as
the ongoing SARC 023 study with the FDA and Pediatric Subcommittee.”
Background material for this meeting will be available on the FDA
website 1-2 days prior to the meeting.
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 its 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", “continues”, "projects", or similar
expressions intended to identify forward-looking statements. Such
statements, including statements relating to the potential outcomes of
the ODAC Pediatric Subcommittee meeting on December 11, 2014 and
potential of ganetespib to treat MPNSTs and other indications, 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, 2013 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.
Daniel Cole,
781-541-7250
dcole@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