We are encouraged by the study’s IDMC findings, and as a result are now more aggressively expanding the study in the US and Western Europe. Our goal, now that the first IDMC interim safety review is behind us, is to further accelerate the patient recruitment by increasing the number of centers from the current 36 centers to, at least, the originally planned 50 centers. We are currently negotiating to bring on highly regarded US hospitals as well as European centers in multiple countries. We will keep you up-to-date on important developments occurring during the trial. We understand the desire of our shareholders to know as much as possible about our study’s progress, but ask you to understand that a lot of information cannot be shared publicly since it might bias the study results, which ultimately could lead to major problems in the Phase III trial and impede the possible approval of Multikine for commercial use by regulatory agencies.
Other company activities: Our L.E.A.P.S. collaborative study with the National Institutes for Allergy and Infectious Diseases (NIAID) on pandemic flu is also progressing well. The testing conducted by NIAID with our L.E.A.P.S. compounds has shown significant promise in animal models of the disease and has been submitted for publication. We believe that the data will potentially be very relevant when the next strain of drug resistant flu makes an appearance.
We are well into the final, and pivotal, study with Multikine designed to definitively prove that it will increase overall survival in a disease with a clear unmet medical need, where the last drug approval was about 50 years ago and where no other drug is in late stage development. Our goal is to replicate the promising results from our Phase II studies and so far that is what we are seeing. From here on we have a clear path to potentially enormous success. Few people ever get the chance to be part of something as significant as this. We thank you for your support during this Phase III clinical trial.
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