An update on Phase 3 ENSPIRIT Trial - Report on OncoGenex Pharmaceuticals

Aug 04, 2015, 09:20 ET from

NEW YORK, August 4, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL:  

Highlights from our OGXI Report include:

  • Plan to continue Phase 3 ENSPIRIT trial - On July 13, 2015, the biopharmaceutical company, OncoGenex Pharmaceuticals, Inc. (OncoGenex) announced that the Company is continuing its Phase 3 ENSPIRIT trial as planned in accordance with the recommendations of an Independent Data Monitoring Committee (IDMC). Phase 3 ENSPIRIT trial is designed to evaluate custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The Company took this decision, to continue the trail, following the completion of the second and final planned interim futility analysis. As reported in the release, OncoGenex filed an amendment with the US Food and Drug Administration (USFDA) amending the statistical design and analysis plan that included a more rigorous and expedient evaluation of the potential survival benefit associated with custirsen in NSCLC. The Company informed that initial results from the Phase 3 ENSPIRIT trial, based on the current enrollment, are likely to be available in the second half of 2016.
  • The Phase 3 ENSPIRIT Trial: a brief description - The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial conducted on 700 patients who have progressed after initial chemotherapy treatment, with a hypothesized hazard ratio (HR) of 0.75 and a critical HR of 0.84. The objective of the trial is to examine if the combination of custirsen with docetaxel has the potential to improve the survival outcomes, as against the independent dosage of docetaxel in these patients. Docetaxel is a standard second-line NSCLC chemotherapy, OncoGenex informed. Having plans to enroll patients in around 50 global sites, the biopharmaceutical major filed an amendment with the USFDA and regulatory agencies in all countries where it is the sponsor. Informing about the experimental drug - custirsen, the Company stated that custirsen is designed to block the production of the protein clusterin, which possibly plays an important role in cancer cell survival and treatment resistance.
  • Recent findings from the trial - As per the release, recent findings from a retrospective analysis of data from the Phase 3 SYNERGY trial showcased benefit when custirsen therapy was used in combination with first-line docetaxel chemotherapy. The treatment was given to men with metastatic castrate-resistant prostate cancer (CRPC) who had a poor prognosis. Over 40% of men in the trial had at least 2 of the 5 common risk factors for poor prognosis, as per the analysis. It was reported that when custirsen was used together with first-line docetaxel as against docetaxel alone, 27% lower risk of death was found in the analysis. Subject to finalizing the pending protocol amendment, timing for the final analysis of the poor prognosis subpopulation in the Phase 3 AFFINITY trial is expected to occur by the end of 2015. Moreover, the final analysis for the intent-to-treat population is likely to occur in the second half of 2016.

To find out how this influences our rating on OncoGenex Pharmaceuticals, Inc., read the full report in its entirety here:

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