Regarding HCV Phase 1B,
Here’s a repeat of what I’ve learned in conversations:
1. There will be a PR when enrollment is complete.
2. The enrollment completion PR could include some general comments about the overall direction of the Ph IB results.
3. In Ph 1B there is no requirement of a waiting period between the completion of one cohort and the start of another.
4. It is possible that some top-line Ph IB data could be presented on Oct 30 for those cohorts that have completed the 12-week wait.
Here’s a repeat of what I think:
I think there’s a good chance we will see the Ph 1B completion PR just prior to the CC on or about Sept. 11. There are 13.5 weeks from June 6 (when we know enrollment started) to Sept 8. Assuming 2 weeks of dosing per cohort plus an additional 7-9 days between cohorts, all four cohorts could be completed by Sept 8. We know that enrollment is “proceeding well.” Can anyone provide a good clinical reason why they would wait more than one week between cohorts if they don’t have to?
I think there’s an excellent chance we will hear top-line Ph 1B data on Oct 30 for those cohorts that have completed the 12-week wait because, as SK indicated in CC on July 14, the possibility of an adaptive immune response is the most exciting scientific aspect of the Bavi cancer and viral trials. Repeat dosing in animals, as compared with single dosing, produced much stronger evidence of “something that really takes place several days later that … leads to longer-term effects.”
If repeat dosing in humans is also producing much stronger evidence of an adaptive immune response than the Ph 1A single dosing data, I can’t believe PPHM would miss the opportunity to present this evidence at a gathering of the world’s leading HCV scientists even if the 12-week data is available only for the first two cohorts.
