IMUC - ImmunoCellular Therapeutics Ltd - Q2 2013 Earnings Call Transcript

    I'll provides some perspective and what we expect to have in during the balance of the trial and how we plan to utilize the outcome of the trial to determine our next clinical and regulatory strategies.

    We were very pleased with the successful outcome of the interim analysis from the Data Monitoring Committee's recommendation to continue the trial to completion which we announced in early June. The Phase II trial will continue as planned with the next milestones slated to be when 64 events location deaths have occurred.

    After reaching the 32nd event that triggered the interim analysis we did a high level blinded reassessment of the potential timing for reaching the 64th event. We want to emphasize that the timing for reaching 64 events is and continues to be not-precisely predictable.

    However we think reaching this event level we needed the third quarter or fourth quarter this year is likely. Just as we required some time after reaching the 32nd event in order for the data monitoring committee to conduct and complete the data analysis, we also anticipate that the analysis of the safety and efficacy data from the Phase II trial will require some time. Because of that analysis will involve the entire data set based from the trial we estimate it will take three to four months to four months to complete following reaching the 64 event.

    What will happen during that three to four months time frame is, reviewing of the file for every patient in the study, verifying that the 64 events have actually occurred, verifying the database, resolving all open issues or questions, locking the database un-blinding the trial and conducting the predefined statistical analysis.

    Based on this timeline, we estimate that the top line read-out of the final data maybe available for us to announce publicly in the fourth quarter of 2013 or the first quarter of 2014. I want to emphasize that this anticipated timeline is based on our current estimate for when we specifically event and the subsequent data analysis process.

    It's important to remember that all company personnel have remained blinded to the data from the interim analysis and all company personnel plan to remain blinded to the results from this trial until we receive the top-line data read out from the contract research organization.

    No one inside or outside of the company has had or will have any basis on which to predict the outcome of this trial until it is completed in the data are analyzed. Once the data analysis has been completed and communicated to the company we'll be in a position to announce the top-line results publicly and equally important to determine what they will tell us about potential mix clinical and regulatory steps for this program, including the possibility of advancing to a registration phase III program. Here are some inside into how we'll be thinking about the results for the trial and those potential mix steps.

    The phase II trial is randomized and controlled and is designed as an exploratory trial that will build upon our understanding of ICT-107 safety and efficacy profile from the Phase I trial. The Phase I trial was highly suggested of ICT-107's potential positive therapeutic benefit, but it was a small uncontrolled trail conducted to the single investigational center.

    So we expect to learn a lot more about ICT-107 from the Phase II trail, which will inform how we approach talking with the FDA in an Phase II meeting and how we could design a Phase III registration program. From our perspective having an objective basis on which to advance the Phase II to Phase III constitutes a successful outcome for this trial. The Phase II trial's primary endpoint is based on overall survival and secondary endpoints includes progression free survival and other key safety and efficacy parameters. The trial is about 80% powered to show the size benefit of nine months in the treated group compared to the placebo group.

    If we need the primary and secondary endpoints and achieve a fee value of 0.05 or lower as stipulated in the protocol, will that will clearly be a successful outcome. We can also invasion other successful outcomes which could support advancing to our Phase III program. For example, if the data come close but do not statistically significance but demonstrate a benefit in the treatment arm, hypothetical less than nine month but a period that would be clinically meaningful to patients.

    That outcome could also provide the basis for designing and conducting a pivotal phase III trial. Similarly if we saw positive trends based on a sub-group analysis of the population enrolled in the trial, for example based on HLA status, where the number and amount of antigen expression of patient's tumors will that would be extremely valuable information as well which could suggest clinical benefit in these subgroup populations and could also support a - into Phase III.

    Thinking about the outcome of the phase II trail in this way is really no different from what other oncology companies do at the end of the phase II trial, the whole purpose of the phase II trial is to provide data that will lead to the design of a pivotal registrational trial in a target indication and in a target population.

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