Viram a subida se hoje? Porquê?
O gajo ontem contou uma boa história sobre o ICT-107
Today we stand at the cusp of achieving a major milestone for ImmunoCellular, with the initiation of our first phase 3 registrational trial. Understanding how we have arrived here is important to understanding the value of ICT-107, and of our Company in general. Almost two years ago, in December of 2013, we announced the first results of the ICT-107 phase 2 trial. We reported that we met the secondary endpoint of improving progression-free survival, but that we missed the primary endpoint of overall survival. In short, the trial failed because it did not meet its primary endpoint, and the market reaction was understandably negative. For the Company, however, the important question was, in light of the failed trial, was the ICT-107 program a failure? In other words, what did the data tell us about how this therapy behaved in patients, and was there a rational base on which to proceed to a phase 3 trial? Based on our extensive data analysis, our answer to the question of whether the program was a failure was, no. Based on the work we have continued to do over the last two years, both inside the Company and with external third parties and regulators, we think ICT-107 has the potential to be the best program underway in newly diagnosed glioblastoma.
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After all, phase 3 is where the number of patients treated is significant and the costs are large. This is rational drug design and development. Our phase 3 trial was no different. Sorry, our phase 2 trial was no different. Yet among the active clinical programs in glioblastoma, ours was the only one to use the registrational endpoint of overall survival and in-trial control group for the phase 2. That was critical to our determination of whether there was an indication of treatment effect.
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As a result, the phase 2 trial provided the wealth of information we needed to proceed with phase 3, and to determine how to optimize the design of the trial. From this standpoint, the results were extremely valuable, even if the trial technically failed. The phase 2 results support the presence of a treatment benefit in comparison to the in-trial placebo arm. This was especially pronounced in the major subgroup population, the HLA-A2-positive patients, who represent about half of all glioblastoma patients in the United States. This is the patient population we will enroll in the phase 3 program.
