OncoGenex Pharmaceuticals, Inc. OGXI today highlighted key
clinical development activities for its two product candidates, custirsen and
OGX-427, and announced its fourth quarter and year end 2012 financial results.
Custirsen Clinical Development Highlights
o The Company announced completion of patient enrollment of more than 1,000
men in the primary registration Phase 3 SYNERGY study in the fourth
quarter of 2012. The SYNERGY study is designed to evaluate a survival
benefit for custirsen, in combination with first-line docetaxel
chemotherapy, in men with metastatic castrate-resistant prostate cancer
(CRPC). The expected timing of results is based on a pre-specified number
of death events that is projected to occur in the fourth quarter of 2013,
with data results expected to be announced in the first half of 2014.
o Patient enrollment began in the third quarter of 2012 in the Phase 3
AFFINITY study, evaluating a survival benefit for custirsen in combination
with Jevtana® (cabazitaxel) as second-line chemotherapy. AFFINITY aims to
enroll approximately 630 men with CRPC and is being conducted at sites
throughout North America, Europe and Australia.
o Patient enrollment began in the third quarter of 2012 in the Phase 3
ENSPIRIT trial, a randomized Phase 3 study in approximately 1,100 patients
with advanced or metastatic non-small cell lung cancer (NSCLC). ENSPIRIT
will evaluate the potential survival benefit of combining custirsen with
docetaxel as second-line chemotherapy. Custirsen has also recently
received Fast Track designation from the FDA for the second-line treatment
of advanced NSCLC when combined with docetaxel in patients with disease
progression following treatment with a first-line, platinum-based
chemotherapy doublet regimen.
OGX-427 Clinical Development Highlights
o In December 2012, the Company announced the initiation of the Pacific
trial, an investigator-sponsored, randomized Phase 2 study evaluating
OGX-427 in approximately 80 men with CRPC who are experiencing a rising
prostate-specific antigen (PSA) while receiving Zytiga® (abiraterone
acetate). The study is currently enrolling at sites in the United States
and Canada.
o The company-sponsored, randomized Phase 2 clinical trial of OGX-427 in
combination with gemcitabine and cisplatin in patients with metastatic
bladder cancer, Borealis-1, continues to enroll patients throughout the
United States, Canada and Europe. The study aims to enroll approximately
180 patients and is expected to complete patient accrual in the second
half of 2013.
o The Company also recently announced plans for the initiation of an
investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in
patients with advanced or metastatic bladder cancer who have disease
progression following initial platinum-based chemotherapy. The trial,
Borealis-2, will seek to enroll approximately 200 patients to receive
either OGX-427 plus docetaxel treatment or docetaxel treatment alone and
is expected to begin in the first half of 2013.
o Pacific, Borealis-1 and Borealis-2 are part of the "ORCA" (On-going
studies evaluating treatment Resistance in CAncer) program that
encompasses clinical studies of OGX-427 across multiple cancer
indications. Plans to initiate additional studies as part of the ORCA
program will be announced in the coming months.
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