Replies to post #69415 on Biotech Values

[DewDiligence]

Re: OGX-011

Agree with your post on all counts except your contention that the ISIS PR does not specify the hazard ratio. From the PR (#msg-33921631):

>>
Results currently indicate that patients in the OGX-011 arm have a death rate approximately 40% lower than patients in the control arm.
<<

An approximately 40% lower death rate means the HR is ~0.60 based on the events observed to date.

[mcbio]

Iwfal: RE OGIX Phase II trial results

I assume by "events" you are referring to patient deaths. Wouldn't the company still be able to report a p-value even if there were few deaths/events? Just wondering if there's any chance that they didn't because the p-value may have been greater than .05 at this point (i.e. not stat sig).

Also, is it a valid concern to wonder if these results only pertain to a few deaths/events? If I understand what you're saying, the strong survival advantage so far may be due to just a few deaths/events so when more do occur the advantage of OGX-011 over the control arm may diminish.

Finally, do you have any thoughts on OGIX as an investment at this level ($25 million market cap)?

[jb_118]

OGXI Update

[Here's the update PR announcing the ASCO abstract. They explicitly stated the HR=.60 in this analysis. As iwfal surmised, the p-value was >0.05 (p=0.07 for this interim analysis), which isn't disclosed here but is in the abstract, which I'll post.]

-- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced the release of two abstracts to be presented during oral presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. Abstracts are now available to the public online on the OncoGenex Web site at www.oncogenex.com in addition to the ASCO Web site, www.abstract.asco.org.

Highlights from the OGX-011 Abstract

At the time data was submitted to ASCO and as previously disclosed in December 2008, the preliminary median overall survival in patients with advanced prostate cancer who were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 27.5 months compared to 16.9 months for patients treated with docetaxel alone. The hazard ratio (HR), a measure used to determine the difference in survival between treatment groups, was 0.60, representing a 40% reduction in the rate of death for patients treated with OGX-011. New data disclosed today include a prospectively defined multivariate analysis evaluating variables predictive of overall survival. The analysis defined only three variables predictive of overall survival: performance status, presence of visceral metastasis and assignment to the OGX-011 treatment arm. Based on the multivariate analysis, patients treated with OGX-011 had a rate of death 46% lower than patients treated with docetaxel alone (HR=0.54; p=0.04).

The abstract represents survival data as of November 2008. Final survival data as of April 2009 for this trial will be presented during an oral presentation at ASCO. [ They made a relatively big deal about this in the last quarterly conference call...namely that the oral presentation at ASCO would have additional data, and they'd have a conference call after ASCO to discuss the data. ]