Clinical trials are a fundamental step in the development of new therapies for
treating virtually every medical condition. At Synta Pharmaceuticals, our
clinical research is focused on innovative therapeutic options that can extend
or enhance the lives of patients in the areas of cancer and inflammatory
diseases. All of the drug candidates currently in development at Synta are
derived from our proprietary chemical compound library and reflect our
commitment to truly original research.
Synta places a high priority on sharing information and results regarding our
ongoing and completed clinical studies with the medical community. We have
registered all of our active, company-sponsored clinical trials on the National
Institutes of Health Web site
www.clinicaltrials.gov. This information is available here on our site,
as well.
No Synta drug candidates have been approved by the FDA or any other regulatory
body for the treatment of diseases.
Elesclomol
Elesclomol is a novel, injectable, investigational drug candidate that triggers
apoptosis (programmed cell death) in cancer cells. Cancer cells operate at high
levels of reactive oxygen species, or oxidative stress. Elesclomol is believed
to act by increasing the level of oxidative stress in cancer cells even
further, beyond sustainable levels, inducing apoptosis. This mechanism of
action, called oxidative stress induction, represents a novel way of
selectively targeting and killing cancer cells.
SYMMETRYSM Elesclomol Trial in Metastatic Melanoma – Phase 3
The SYMMETRY trial enrolled 651 patients with Stage IV metastatic melanoma, who
had not received prior chemotherapy. Patients were randomized (1:1) to
elesclomol (213 mg/m2) plus paclitaxel (80 mg/m2) or paclitaxel alone (80
mg/m2). The control arm treatment, the combination arm treatment and the
primary endpoint – progression free survival (PFS) – were the same as in the
prior Phase 2b trial.
In February 2009 Synta Pharmaceuticals announced that it had suspended the
SYMMETRY trial and other ongoing studies with elesclomol based on an analysis
by the independent Data Monitoring Committee that identified possible safety
concerns. Preliminary results from the trial were presented at ASCO in May
2009. Further analyses of results from the trial are ongoing and are expected
to be presented later in 2009 or early 2010.
For more information on the SYMMETRY trial, please see
www.clinicaltrials.gov, study number NCT00522834.
Elesclomol Trial in Metastatic, Hormone Refractory Prostate Cancer – Phase 1/2
This open-label Phase 1/2 study of elesclomol in combination with docetaxel in
patients with advanced metastatic, hormone refractory prostate cancer is
designed to identify the maximum tolerated dose of elesclomol in combination
with docetaxel based on a once-a-week, one-hour intravenous dosing schedule.
This study uses a new, water soluble (sodium salt) formulation, allowing
flexible administration, either as monotherapy or in combination with other
anti-cancer agents. This trial is on hold pending further analysis of the
results of the SYMMETRY trial.
Elesclomol Monotherapy Trial in Solid Tumors – Phase 1
This open-label, Phase 1 dose-escalation study of elesclomol in patients with
advanced metastatic or unresectable solid tumors is designed to identify the
maximum tolerated dose of elesclomol sodium based on a weekly infusion dosing
schedule. This study uses a new, water soluble (sodium salt) formulation,
allowing flexible administration, either as monotherapy or in combination with
other anti-cancer agents. This trial is on hold pending further analysis of the
results of the SYMMETRY trial.
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STA - 9090
STA-9090 is a novel, synthetic, injectable, small molecule Hsp90 inhibitor
(inhibits heat shock protein 90 (Hsp90), a chaperone that regulates numerous
proteins that drive proliferation in cancer cells, in particular kinases) with
a novel chemical structure that is unrelated to the Hsp90 inhibitor
geldanamycin or its family of related compounds, such as 17-AAG.
STA-9090 Trial in Solid Tumors Twice-a-week Dosing– Phase 1
In November 2007, the first patient was dosed in this open-label Phase 1 study
in patients with solid tumors designed to identify the maximum tolerated dose
of STA-9090 based on a twice-a-week intravenous dosing schedule. In addition to
an evaluation of safety and tolerability, patients will be assessed for
response rate based on the RECIST criteria.
STA-9090 Trial in Solid Tumors Once-a-week Dosing– Phase 1
In January 2008, the first patient was dosed in this open-label Phase 1 study in
patients with solid tumors designed to identify the maximum tolerated dose of
STA-9090 based on a once-a-week, one-hour intravenous dosing schedule. In
addition to an evaluation of safety and tolerability, patients will be assessed
for tumor response based on the RECIST criteria.
STA-9090 Trial in Hematologic Malignancies Twice-a-week Dosing– Phase 1/2
In March 2009, the first patient was dosed in this open-label Phase 1/2 study in
patients with hematologic malignancies designed to identify the recommended
dose of STA-9090 for further study in a hematologic population, based on a
twice-weekly intravenous dosing schedule, and to characterize its safety and
efficacy profile in this patient population.
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Apilimod
Apilimod is a novel, orally administered, small molecule that inhibits the
production of the cytokines interleukin-12 (IL-12), and interleukin-23 (IL-23),
down-regulating the inflammation pathways that drive certain autoimmune and
inflammatory diseases.
Apilimod Trial in Rheumatoid Arthritis – Phase 2a
In May 2006, the first patient was dosed in this randomized, placebo-controlled
study of apilimod mesylate in combination with methotrexate. This
biomarker-based study assessed the efficacy of the drug by examining its effect
on synovial tissue in patients with rheumatoid arthritis. The study has
completed initial enrollment of 22 patients and the preliminary results showed
encouraging biomarker and clinical signals suggesting activity of apilimod in
this indication. An additional cohort of patients is currently being enrolled
in this trial to explore a higher dose of apilimod.
Contact Information:
Synta Pharmaceuticals
45 Hartwell Avenue
Phone 781-541-7125
Fax 781-274-1270
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