Final data from the failed, Phase III, AFFINITY trial of curstirsen + cabazitaxel + prednisone

In August we had reported on an announcement by OncoGenex Pharmaceuticals that, in the Phase III AFFINITY trial, the combination of custirsen + cabazitaxel (Jevtana) + prednisone had no significant impact on overall survival of men with metastatic, castration-resistant prostate cancer (mCRPC) who had already received first-line chemotherapy by comparison with cabazitaxel + prednisone alone. … READ MORE …

Custirsen shows no benefit in combination with cabazitaxel in mCRPC

Early this morning, OncoGenex announced the result of final analysis of data from the Phase III AFFINITY trial of custirsen + cabazitaxel + prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) who had progressed after docetaxel chemotherapy. … READ MORE …

Custirsen does NOT significantly extend survival in men with mCRPC

OncoGenex and Teva stated earlier today that the addition of custirsen (OGX-011) to docetaxel + prednisone did not demonstrate any significant effect on the overall survival of men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

OncoGenex gets addditional “fast track” designation for custirsen

According to a media release from OncoGenex, the U.S. Food & Drug Administration has granted a “fast track” designation to the evaluation of data from the so-called AFFINITY trial of custiren + carbazitaxel + prednisone as a second-line treatment for men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Results of Phase III trial of custirsen (OGX-011) in mCRPC coming soon

According to a media release issued early this morning by OncoGenex Pharmaceuticals, the Phase III SYNERGY trial of custirsen (originally known as OGX-011) has reached its pre-specified endpoint in terms of the number of events required for final analysis of the trial data. … READ MORE …

Sometimes there is no useful information in that corporate media release

According to a media release issued by OncoGenex Pharmaceuticals earlier today, the Phase III SYNERGY trial of docetaxel + prednisone + custirsen vs. docetaxel + prednisone + a placebo will be “continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC).” … READ MORE …

OncoGenex completes enrollment of patients to Phase III trial of custirsen in mCRPC

Well, it’s taken a little over 2 years, but OncoGenex has completed enrollment of patients into the randomized, double-blind, Phase III SYNERGY trial, which is designed to assess whether the addition of custirsen (OGX-011) to docetaxel-based chemotherapy can extend the survival of men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

OncoGenex starts enrollment in new Phase III trial of custirsen

According to a media release from OncoGenex Pharmaceuticals earlier today, the company has started to enroll patients in a second, randomized, Phase III clinical trial of custirsen (OGX-011), this time in combination with second-line chemotherapy. … READ MORE …

OncoGeneX/Teva halt SATURN trial, start new Phase III study with OGX-011

According to a media release from the companies issued yesterday, OncoGeneX and Teva have stopped enrolling patients into the SATURN trial, which was designed to see if OGX-011 (custirsen) could ameliorate bone pain … READ MORE …

Oncogenex makes SATURN trial of custirsen (OGX-011) more accessible

The Phase III SATURN clinical trial of OGX-011 in treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) after initial chemotherapy with docetaxel + prednisone required men to be randomized to either docetaxel + prednisone + OGX-011 or to docetaxel + prednisone + a placebo. … READ MORE …

Data published from Phase II trial of OGX-011 (custirsen)

Back in 2009 we reported the results of a randomized Phase II trial of docetaxel + OGX-011 vs. docetaxel + placebo as they were initially presented at the annual meeting of the American Society of Clinical Oncology in Chicago (ASCO). … READ MORE …

OncoGenex starts first Phase III trial of custirsen sodium (OGX-011) in mCRPC

OncoGenex has initiated the first of two Phase III trials of custirsen sodium (OGX-011) in the treatment of men with metastatic castrate-resistant prostate cancer (mCPRC). … READ MORE …