Cancer has been an elusive target for Isis Pharmaceuticals ISIS and their antisense drug candidates over the years, resulting in some spectacular failures in the past. In addition to the impending phase 3 prostate cancer data from partners OncoGenex $OGXI and Teva Pharmaceuticals $TEVA, Isis also has a growing roster of early stage cancer assets, a number of which now are included in a preferred partner option arrangement with AstraZeneca $AZN.
Conference call excerpts (edited for accuracy) c/o SeekingAlpha.
ISIS-ARRx blocks both normal and mutant forms of AR (androgen receptor), which has been a challenge for small molecules...Our next step, if you complete the necessary pre-clinical studies to support clinical development and then advance ISIS-ARRx into clinical trials in prostate cancer. And just as we are doing with our Stat3 program, we in AstraZeneca plan to conduct a broad Phase 2 Program for ISIS-ARRx that evaluates the drug in a variety of clinical settings including patients who developed resistance to current anti-androgen therapies in combination with these therapies and in combination with chemotherapy.
The Phase 1 study was completed in 15 patients with advanced cancers. Three of the 15 patients had diffuse large B-cell lymphoma and two of these three patients experienced durable, partial responses as a consequence of ISIS-STAT3 treatment.
Consequently, together with AZ we have designed the development program to explore the effects of ISIS-STAT3Rx in a number of different cancers. This includes an ongoing Phase 2 study in patients with advanced lymphoma [data expected in 2013] and a recently initiated Phase 2 study evaluating the safety and efficacy of ISIS-STAT3Rx in patients with liver cancer. The endpoints for these studies include measurements of anti-tumor activity, STAT3 protein levels and tumor biopsies and STAT3 related biomarkers. We believe these studies will provide the information we and AstraZeneca need to establish in the next stage of our development strategy for ISIS-STAT3Rx
Of course our cancer pipeline is broader than the two drugs that we’ve been discussing today, so over the next year there will be a number of important clinical results. Teva and OncoGenex should complete the first of three Phase 3 studies with OGX-011 in patients with castrate resistant prostate cancer early next year.
OncoGenex plans to complete a phase 2 study of OGX-427 in patients with prostate cancer. This year, we plan to report data from our Phase 2 studies of eIF4E drug this year.
no questions from the audience...
ISIS-ARRx blocks both normal and mutant forms of AR (androgen receptor), which has been a challenge for small molecules...Our next step, if you complete the necessary pre-clinical studies to support clinical development and then advance ISIS-ARRx into clinical trials in prostate cancer. And just as we are doing with our Stat3 program, we in AstraZeneca plan to conduct a broad Phase 2 Program for ISIS-ARRx that evaluates the drug in a variety of clinical settings including patients who developed resistance to current anti-androgen therapies in combination with these therapies and in combination with chemotherapy.
The Phase 1 study was completed in 15 patients with advanced cancers. Three of the 15 patients had diffuse large B-cell lymphoma and two of these three patients experienced durable, partial responses as a consequence of ISIS-STAT3 treatment.
Consequently, together with AZ we have designed the development program to explore the effects of ISIS-STAT3Rx in a number of different cancers. This includes an ongoing Phase 2 study in patients with advanced lymphoma [data expected in 2013] and a recently initiated Phase 2 study evaluating the safety and efficacy of ISIS-STAT3Rx in patients with liver cancer. The endpoints for these studies include measurements of anti-tumor activity, STAT3 protein levels and tumor biopsies and STAT3 related biomarkers. We believe these studies will provide the information we and AstraZeneca need to establish in the next stage of our development strategy for ISIS-STAT3Rx
Of course our cancer pipeline is broader than the two drugs that we’ve been discussing today, so over the next year there will be a number of important clinical results. Teva and OncoGenex should complete the first of three Phase 3 studies with OGX-011 in patients with castrate resistant prostate cancer early next year.
OncoGenex plans to complete a phase 2 study of OGX-427 in patients with prostate cancer. This year, we plan to report data from our Phase 2 studies of eIF4E drug this year.
no questions from the audience...
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