Myrexis Reports Azixa Phase 2 Study Results at 2011 American Society of Clinical Oncology Annual Meeting

Myrexis MYRX today announced presentation of Phase 2 clinical study results from its lead product candidate Azixa (verubulin) at the 2011 American Society of Clinical Oncology Annual Meeting, June 3-7, 2011, in Chicago, IL. The Phase 2 results are from the Company's open-label Azixa monotherapy study in patients with recurrent glioblastoma multiforme who had failed prior standard of care chemotherapy, but who are naïve to Avastin®(bevacizumab). "Glioblastoma patients who relapse following standard first-line therapy are limited in terms of treatment options," stated Adrian N. Hobden, Ph.D., President and CEO of Myrexis. "We are encouraged by the anti-tumor activity exhibited by single-agent Azixa. These results, together with those from previous studies of Azixa in patients with GBM, provide further rationale for the ongoing Phase 2b comparative arm study of Azixa in newly diagnosed GBM patients." There were 31 patients with recurrent GBM enrolled in this arm of the Phase 2 Azixa monotherapy study who had failed temozolomide and were naïve to treatment with Avastin. Two patients (6.5%) achieved partial response as assessed by Macdonald criteria. Another patient (3.2%) with two tumor lesions at baseline responded with no detectable disease after cycle 13 of Azixa treatment and continues to receive Azixa. A further five patients (16.1%) achieved stable disease. The median duration of stable disease was four months and the median duration of partial response was six months. The median progression-free duration was 1.8 months (range 0.04-13.1) and the median overall survival was 9.9 months (range 1.1-17.2). The most common adverse events were fatigue (26%), nausea (10%), and constipation (10%). In November 2010, Myrexis reported results from the Avastin-experienced cohort of this Phase 2 study at the annual meeting of the Society for NeuroOncology (SNO), demonstrating that Azixa monotherapy was well-tolerated and exhibited anti-tumor activity comparable to commonly prescribed third-line GBM agents. One patient from this cohort achieved a partial response, as assessed by standard criteria, with 80% tumor reduction over twelve months of Azixa treatment. Four additional patients experienced stable disease. In December 2010, Myrexis initiated a two-arm Phase 2b trial of Azixa in patients newly diagnosed with GBM. Patients are randomized to receive either Azixa in combination with standard of care therapy, which includes radiation treatment and temozolomide, or the standard of care therapy alone. This study is expected to enroll up to 120 newly diagnosed GBM patients. The Company also presented a second poster highlighting preclinical findings from its potential best-in-class cancer metabolism inhibitor (CMI) program. MPC-9528, which is currently in IND-enabling studies and MPI-0487316, representing a structurally distinct lead class of CMI compounds, both demonstrated flexible dosing and dramatic tumor regression across multiple tumor types. MPC-9528 is an orally bioavailable small molecule inhibitor of the enzyme Nicotinamide phosphoribosyltranferase (Nampt). Nampt inhibition results in tumor cell death following depletion of a critical metabolic coenzyme, nicotinamide adenine dinucleotide (NAD).