Azixa™

Description

EP90745 is a series of apoptosis inducer compounds for the treatment of cancer. In December 2003, EpiCept granted an exclusive, worldwide development commercialization agreement for the EP90745 series to Myrexis, Inc. Myrexis (formerly Myriad Pharmaceuticals, Inc.) has taken on the responsibility for the clinical development and commercialization of this series of compounds, which includes Azixa™ (MPC6827). The license agreement calls for Myrexis to pay milestone payments, license fees and research support, as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series.

In August 2006, Myrexis reported positive clinical results for Azixa™, the lead compound in the series, in a total of 66 patients – the first confirmed clinical proof of concept for EpiCept’s proprietary live cell high-throughput caspase-3 screening technology. Myrexis reported that in a Phase I study of Azixa™ in cancer that has metastasized to the brain, the drug achieved its maximum tolerated dose in patients. Myrexis also noted a measured reduction in tumor size in certain patients, suggesting evidence of activity. Azixa™ is now in Phase II clinical development.

In November 2009 Myrexis announced interim results of its trial of Azixa™ in melanoma metastases in which ten of the 22 patients treated achieved stable disease and two patients achieved confirmed partial responses. The median progression-free survival was 2.8 months. Azixa™ has received orphan drug status in the United States for the treatment of glioblastoma.

In June 2010, Myrexis provided an update at the meeting of the American Society of Clinical Oncology (ASCO).  In the glioblastoma trial, six subjects achieved stable disease and two subjects had achieved partial responses.  One subject’s partial response duration was 7.8 months; the additional patient’s response was, at the time of the ASCO report, 16 months in duration and has been classified as almost a complete response.

In November 2010, Myrexis presented a poster with updated results from ongoing open–label Phase II monotherapy study of Azixa™ in treatment-experienced patients with glioblastoma multiforme (GBM) at the Society for Neuro-Oncology Scientific Meeting and Education Day in Montreal Canada.

In December 2010, EpiCept reported that Myrexis had initiated a controlled two-arm Phase IIb study of Azixa™ as a front-line treatment for GBM.  The study will enroll up to 120 newly diagnosed GBM patients in the U.S. and India in order to evaluate Azixa™ combination therapy as a first line GBM treatment.  The trial will compare standard of care in this disease with standard of care in combination with Azixa™.

The dosing of the first patient in a Phase III trial triggers a milestone payment to EpiCept.