Synta Pharma Home



CLINICAL TRIALS

Elesclomol | STA-9090 |  Apilimod

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.

[Top of page]

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.

[Top of page]

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

[Top of page]

ABOUT |  PIPELINE | CLINICAL TRIALS |  TECHNOLOGY |  INVESTORS  |  CAREERS

Copyright © 2009Synta Pharmaceuticals Corp. All rights reserved. Terms of Use