OncoGenex Pharmaceuticals, Inc. (OGXI) recently announced the commencement of a phase II trial, Spruce, on its oncology candidate OGX-427.
We note that OncoGenex is evaluating OGX-427 for the treatment of previously untreated advanced non-squamous non-small cell lung cancer (:NSCLC).
The investigator-sponsored, randomized, double-blind, placebo-controlled phase II study, Spruce, will randomize 155 patients suffering from non-squamous NSCLC to receive carboplatin and Alimta plus either OGX-427 or placebo.
The primary endpoint of the trial is progression-free survival (PFS).
We note that apart from Spruce, OGX-427 will be evaluated under another phase II trial for NSCLC – Cedar. The trials are part of the ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program, which is evaluating OGX-427 for the treatment of advanced cancers.
In the Cedar study, patients will be randomized to receive OGX-427 plus Gemzar and carboplatin or Gemzar and carboplatin alone. This study, which is scheduled to commence later this year, will be conducted in patients with previously untreated, advanced, squamous cell lung cancer.
Apart from OGX-427, OncoGenex is developing custirsen in collaboration with Teva Pharmaceutical Industries Ltd. (TEVA).
Custirsen, a phase III candidate, is being developed for the treatment of metastatic castrate-resistant prostate cancer in men. Custirsen is also being evaluated for NSCLC.
The successful development and commercialization of both these candidates will be a major positive for OncoGenex. OncoGenex currently has no approved drug in its portfolio. We expect investor focus to remain on both Spruce and Cedar along with updates on custirsen.
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