DR. OKARMA: Thank you, David. Good morning, everyone. Thank you for dialing in. I will briefly go over the main highlights of the second quarter for our company.
First, at the beginning of April, we announced the initiation of our second Phase I trial of our telomerase inhibitor drug, GRN163L. This trial is in patients with solid tumor malignancies and at the present time is at a single site, the University of Chicago under Dr. Mark Ratain's direction. This trial is a dose escalation cohort design, but it's a bit faster than the CLL trial. We've reduced the infusion duration to only two hours and each cohort has a minimum of one subject before doses can escalate. The primary purpose of this trial is to be–to verify that PK and PD parameters and any dose limiting tox we may see in solid tumors cancers are equivalent to those that we might see in CLL. So this trial obviously complements the ongoing Phase I/II in CLL at North Shore, Long Island Jewish, Cornell and Ohio State that is ongoing.
A few days later, also at the beginning of April, we announced multiple presentations on telomerase at the AACR meetings. I'll only summarize two that I think are the most important. First, a preclinical study, studying our drug, 163L in lung cancer. And this was the first publication of an additional mechanism of action that we have been noticing of–with the drug which has to do with its anti-metastatic effect. The drug, independent of its telomerase inhibition effect or those effects on telomere length, alters cellular adhesion which has in vivo the impact of significantly decreasing metastatic activity of cells. We've noted this phenomenon with a variety of tumor types; this report focused on lung cancer, demonstrating that the 163L effect not only was significant in vitro but also significantly reduced metastatic lung cancer in animals in vivo.
A second presentation was a follow-on study from our investigator at Duke, Johannes Vieweg, on the vaccine, GRNVAC1. This presentation presented data from an alternative manufacturing scheme for the vaccine. This looked at in situ activation of the telomerase mRNA loaded dendritic cells with a material called imiquimod. This topical application saves a few days in manufacturing. The data demonstrated that once again we were able to reproduce the prior, very high and specific immune responses using these in situ activated DCs at one optimized dose of imiquimod. In addition, we demonstrated that we also had significant impact on PSA doubling time, as we had published last year in the Journal of Immunology. So the significance of this report is that it's another alternative to manufacturing and demonstrates the reproduction of our first results in prostate cancer. |
