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Zenith's BET Inhibitor ZEN-3694 is Currently Being Evaluated in Multiple Oncology Clinical Trials

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Message: ZEN-3694 Single Agent Trial Status

The point of the dose escalation was to find the maximum tolerated dose (MTD). Therefore, some adverse events and major side effects are expected at the MTD. They have determined the MTD, and have now decided upon the optimal dose to use for the dose confirmation/expansion cohort. So the issue of safety in a Phase 1 dose escalation trial is mainly involved in finding the highest dose that doesn't cause the side effects of the next highest dose. In my opinion, Zenith is fortunate that several other pan BET inhibitors have been in completed or ongoing clinical trials already. Zenith has stated that they have an on-target safety profile, which I interpret as eliciting the expected side effects observed with other pan BET inhibitors. So I don't see the trial being stopped for safety issues. 

As for efficacy..... those endpoints are secondary in this Phase 1 trial so lack of efficacy likely would not lead to early  trial termination. Zenith has shown some gene expression data suggesting that ZEN-3694 is eliciting target modulation. And there was a poorly captioned MRI image in last month's slides. But other than that we have very little info on efficacy. Since they have only just recently begun the dose confirmation/expansion phase, they may not have enough patients that have been dosed long enough at the recommended Phase 2 dose to make a solid efficacy call. But I bet they have a pretty good idea by now if it is working. Hopefully we hear something soon. 

BearDownAZ 

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