Myrexis commences Azixa controlled two-arm Phase 2b clinical study in GBM

Dec 23 2010

Myrexis, Inc. (Nasdaq:MYRX), a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced it has initiated a controlled two-arm Phase 2b clinical study of Azixa (verubulin) as a front-line treatment for glioblastoma multiforme (GBM).

In previous Phase 2 studies, Azixa demonstrated potent, durable antitumor responses without any additive toxicity. A 31 year old GBM patient who has completed treatment in one Phase 2a combination study with Azixa and who currently has no signs of the disease commented, "my tumor began to shrink shortly after starting therapy and today the tumor cannot be seen on MRI. I recently returned from a hunting and fishing trip, and it felt great to be back doing the things I love with my family [….] I think the Azixa treatment had a lot to do with where I am today."

The study initiated earlier this week will enroll up to 120 newly diagnosed GBM patients at treatment centers in the United States and India in order to evaluate Azixa combination therapy as a first-line GBM treatment. The trial will compare standard of care with standard of care in combination with Azixa.

"Our previous clinical studies have suggested that treatment with Azixa early in a patient's disease and in combination with chemotherapeutics, may result in improved outcomes. For that reason we have decided to evaluate Azixa as a first-line GBM therapy in combination with the standard of care," stated Dr. Adrian Hobden, Chief Executive Officer of Myrexis. "Our objective in designing the comparative Phase 2b study is to support a pivotal Phase 3 program that will bring us closer to approval and commercialization of Azixa."

Myrexis is currently evaluating Azixa as a second- and third-line GBM treatment in an ongoing Phase 2a single-agent study. The Company recently presented promising preliminary data for the first GBM population of patients who have failed both first-line temozolomide and second-line Avastin treatments, and expects to report data from the second sub-group, which consists of recurrent GBM patients who are naive to Avastin treatment in the first half of 2011.