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Veloxis Announced Enrollment Completion for Phase III 3002 LCP-Tacro Pivotal Clinical Trial


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-Enrollment of >540 Patients Completed Sooner than Expected-


Report is Available for Download at: www.lifesciadvisors.com/clients/veloxis

Last Thursday morning, Veloxis Pharmaceuticals (OMX: VELO) issued a press release announcing that patient enrollment has been completed for the Phase III 3002 Clinical Trial. This study is evaluating LCP-Tacro and its ability to prevent graft rejection in de novo kidney transplant patients. The first of two Phase III studies, 3001 in stable kidney transplant patients, already reported positive results.

As we previously discussed in our fourth quarter and year-end earnings note, the completed Phase III 3001 Study met all primary and secondary endpoints (http://lifesciadvisors.com/news/veloxis-announced-year-end-results/). We consider the once-daily dosing of LCP-Tacro to give it a considerable marketing advantage over twice-daily Prograf, but perhaps one of the more interesting findings from the study was that LCP-Tacro actually demonstrated a numerical trend towards lower rejection rates as determined by central blinded pathology readings (LCP-Tacro BPAR rate 0.6%, n=1; Prograf 3.1%, n=5; p=0.214).

Phase III 3002 LCP-Tacro Study Completed Enrollment Earlier than Expected. Veloxis completed enrollment of over 540 patients at 90 clinical sites around the world into the pivotal Phase III 3002 Study of LCP-Tacro in de novo kidney patients. We report that the enrollment objective for this study was completed earlier than the previously reported date of April 12. The goal of this study is similar to 3001, but it is being conducted in the de novo kidney transplant population, which means that these patients have not received prior Prograf therapy or any other drugs to prevent transplant rejection. This is opposed to the successful 3001 Study, which was a crossover study, meaning that patients first received Prograf, then were switched to LCP-Tacro.

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