Posting here has become so frustrating (Yahoo's infernal spam filter swallowed several previous attempts.) In any event, following is Adam Feuerstein's synopsis on 011. AF is a biotech journalist (not an analyst.) Although he is sometimes accused of bashing, I've found most of his articles to be substantive rather than subjective. I've taken a 50% position in OGXI, and intend to buy the rest (double down) if 011 disappoints. Of course, I'd be very happy with what I have if OGXI were to surprise to the upside based on 011 news. FWIW, AF on 011:
OGX-011 is designed to inhibit a protein known as clusterin that plays a role in cell survival. By knocking out clusterin in tumors, OGX-011 makes cancer cells more vulnerable to chemotherapy and other tumor-killing drugs.
OGX-011 is being developed in prostate cancer as an add-on to Taxotere, the chemotherapy drug considered standard of care for patients with advanced disease. In a phase II study enrolling 82 patients and presented in 2009, the median overall survival for the men treated with OGX-011 plus Taxotere was 23.8 months compared to 16.9 months for men treated with Taxotere alone -- an improvement in survival of 6.9 months favoring OGX-011. Expressed another way, treatment with OGX-011 reduced the risk of death by 39% compared to treatment with Taxotere alone.
While this result was not statistically significant, the strong trend favoring a survival benefit for OGX-011 was compelling because the data came from a randomized, controlled trial.
Doubts cast upon the reliability of the phase II data centered mainly around the fact that OGX-011's survival benefit came despite the drug having little or no measurable effect on tumor progression compared to Taxotere alone. Fifty-eight percent of men treated in the OGX-011 arm reported a PSA response compared to 54% of men in the Taxotere-alone arm. PSA is a commonly used biomarker for prostate tumor growth. Progression-free survival was 7.3 months for the OGX-011-treated men compared to 6.1 months for the men treated with Taxotere alone. The median number of treatment cycles administered was also greater in the OGX-011 arm (nine cycles) compared to seven cycles for men in the Taxotere arm of the study.