Vical's CEO Discusses Q1 2012 Results - Earnings Call Transcript

Vijay Samant



Thank you, Jill. I will begin with an update on our Phase 3 Allovectin program for patients with metastatic melanoma. Allovectin is our lead program. We are excited by our progress to-date in approaching the trial completion. We believe we have designed an excellent trial to highlight the patient benefits of immunotherapy compared with chemotherapy. We believe we have selected the right set of patients to demonstrate the benefits of immunotherapy. We believe our trial execution and data collection are well-managed, and definitely designed a data adjudication process for the primary endpoint, and believe the trial is adequately powered to demonstrate statistical significance on both the primary and secondary endpoints, and finally we expect to release the top-line data from both the endpoints by the end of the year.

As a reminder, we enrolled 390 subjects starting in Jan of 2007, ending in Feb 2010. Our trial allowed up to two years of treatment, so the last patients enrolled could have received treatment until Feb of 2012, as long as they had stable disease or partial responses. Those last patients enrolled completed their final treatments in Feb, and they completed their last post-treatment safety follow-up visits by the end of March, so the treatment stage of the trial is now complete. We are currently finishing the final data audits to verify that all the patient records are complete and correct. We expect to complete the data collection and the audit process for the primary efficacy endpoint response rate by the end of this month. That clears the path for completion of our independent endpoint assessment and adjudication process for our response rate endpoint. This process is two distinct steps, radiology and oncology, and they are conducted sequentially. They are pretty comprehensive steps.

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