OncoGenex’s Spruce Clinical Trial Evaluating OGX-427 Is Open for Enrollment

OncoGenex Pharmaceuticals, Inc, has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase 2 trial evaluating OGX-427, a heat shock protein 27 (HSP27) inhibitor, in patients with previously untreated, advanced, nonsquamous non–small-cell lung cancer (NSCLC).

Spruce will randomize approximately 155 patients with nonsquamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy, or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective of the trial is progression-free survival, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on HSP27 levels.

“There continues to be an urgent need for a majority of patients with lung cancer who lack specific biomarkers and will receive nontargeted treatments like chemotherapy,” stated David Spigel, MD, Director of the Lung Cancer Research Program at the Sarah Cannon Research Institute (SCRI), in Nashville, TN, and the primary investigator on the trial. “We hope that opening this trial will lead to us better understanding the role of Hsp27 in non-small cell lung cancer, and the ability of OGX-427 to work with chemotherapies in order to delay or prevent treatment resistance and improve survival outcomes for these patients.”

Spruce is sponsored by SCRI and will be conducted at approximately 20 sites within the SCRI network in the United States. Visit http://clini caltrials.gov/show/NCT01829113 for more information. Spruce is one of 6 phase 2 clinical trials in the ORCA Program evaluating OGX-427 in the treatment of advanced cancers, and the first of 2 randomized phase 2 trials of OGX-427 in NSCLC to open. OncoGenex also recently announced plans to initiate the Cedar clinical trial, an investigator-sponsored, randomized, open-label phase 2 trial evaluating OGX-427 in patients with previously untreated, ad­-vanced, squamous cell lung cancer. Cedar is being conducted in partnership with the UK National Cancer Research Network and the UK Experimental Cancer Medicine Centre Network and is expected to begin enrollment later this year.—Source: OncoGenex, August 1, 2013

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