Nov 20 2010
Myrexis, Inc. (Nasdaq:MYRX), a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced a poster presentation of its lead product candidate Azixa™ (verubulin, MPC-6827) at the 2010 Society for Neuro-Oncology Scientific Meeting and Education Day in Montreal, Canada.
Dr. Sean Grimm of the Northwestern University Brain Tumor Institute was the lead author on a poster titled, "Phase 2 study of Azixa (MPC-6827) for the treatment of glioblastoma after bevacizumab failure," which highlighted updated results from a subset of patients in the ongoing, open-label Phase 2 monotherapy study of Azixa in treatment-experienced patients with recurrent glioblastoma multiforme (GBM).
Azixa monotherapy was well-tolerated and demonstrated anti-tumor activity with a mean overall survival of 105 days in patients who had failed prior Avastin® (bevacizumab) treatment. In this cohort, one patient, in his twelfth month of Azixa treatment and whose treatment is continuing, has seen tumor regression of more than 80%, and four additional patients experienced stable disease.
"The overall prognosis for GBM patients who fail second-line Avastin therapy is extremely poor. We believe that the best approach to improving the prognosis of GBM is to treat patients with Azixa earlier in their disease," said Dr. Adrian Hobden, President and Chief Executive Officer of Myrexis Inc. "Azixa represents a novel therapeutic with high CNS penetration and encouraging signs of activity in GBM patients. We intend to initiate a study of Azixa in combination with temozolomide and radiation therapy in newly diagnosed patients with GBM."
The poster focused on the subset of patients with the poorest prognosis, whose disease progressed following both first- and second-line treatments, including Avastin. Another subset of patients had only failed first-line therapy, which consists of temozolomide and radiation therapy. Data from this second arm will be reported next year. In addition to this ongoing Phase 2 Azixa monotherapy study in treatment-experienced GBM patients with recurrent disease, Myrexis plans to initiate enrollment in a Phase 2b clinical study of Azixa in front-line GBM patients later this year. The planned two-arm, randomized, controlled study will evaluate Azixa in combination with standard of care, which consists of temozolomide plus radiation therapy, compared to standard of care alone.