LEXINGTON, Mass.--(BUSINESS WIRE)--
Elesclomol is an investigational first-in-class oxidative stress inducer that triggers apoptosis (programmed cell death) in cancer cells. Elesclomol is currently being studied in combination with paclitaxel in an on-going Phase 3 clinical trial (SYMMETRYSM) in metastatic melanoma. Synta also recently initiated a Phase 1/2 clinical trial of elesclomol in combination with docetaxel in hormone refractory metastatic prostate cancer with trials in other indications planned for 2009. Elesclomol is not yet approved for any indication in any market.
Under the terms of the collaborative agreement with GSK, Synta is
eligible for a total of
$145 millionin melanoma-related operational and regulatory milestones, including: o $25 millionfor milestones achieved and announced previously; o $10 millionfor milestones achieved and announced today; o $10 millionfor additional milestones expected prior to completion of enrollment; o $25 millionupon meeting the primary endpoint or agreement to file for regulatory approval; and o $75 millionin potential milestone payments for melanoma regulatory filings and approvals.
$440 millionin milestone payments for clinical and regulatory progress in other cancer indications, including; o $5 millionin milestones announced today.
In addition to the above pre-commercial milestone payments, Synta is
As previously announced, Synta expects to complete enrollment in the Phase 3 SYMMETRY trial in January or February of 2009 and conduct the primary endpoint analysis for progression- free survival shortly thereafter.
Synta and GSK are working closely together to further the clinical development of elesclomol as well as prepare for the manufacture and commercial launch of elesclomol.
Elesclomol is an investigational first-in-class oxidative stress inducer that triggers apoptosis (programmed cell death) in cancer cells. Cancer cells operate at high levels of reactive oxygen species, or oxidative stress. Elesclomol acts 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.
In a double-blind, randomized, controlled Phase 2b clinical trial in 81 patients with stage IV metastatic melanoma, elesclomol in combination with paclitaxel met the primary endpoint, doubling the median time patients survived without their disease progressing, compared to paclitaxel alone (p = 0.035). The most common adverse events in the elesclomol plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and anemia.
A pivotal Phase 3 clinical trial of elesclomol in combination with paclitaxel in patients with stage IV metastatic melanoma (the SYMMETRYSM trial) is ongoing; Phase 2 trials in other indications, and in combination with other agents, are planned. Elesclomol has received Fast Track and Orphan Drug designation from the FDA for metastatic melanoma, and the Phase 3 SYMMETRY trial has completed a Special Protocol Assessment process with the FDA. Information about the SYMMETRY trial can be found at www.symmetrymelanomastudy.com, or www.clinicaltrials.gov, (NCI identifier # NCT00522834).
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