Myriad has initiated a third Phase II clinical trial for Azixa in patients with non-small-cell lung cancer that has spread to the brain. The trial is designed to assess Azixa’s safety profile and the extent to which it can improve the overall survival of these patients. Two additional Phase II trials for Azixa are underway in primary brain cancer and melanoma that has spread to the brain.
Myriad is responsible for the worldwide development and commercialization of Azixa and any drug candidate that is developed from the series of compounds licensed by EpiCept to Myriad in 2003. The agreement requires that Myriad make future licensing, research and milestone payments to EpiCept, as well as pay a portion of any sublicensing income and pay a royalty on product sales.
EpiCept will earn a milestone payment upon the dosing of the first patient in a Phase II trial and another milestone upon the dosing of the first patient in a Phase III trial for any use of the drug.
Myriad also reported data from two completed Phase I clinical trials of Azixa in a total of 66 patients, one in patients with refractory solid tumors that may also have had brain metastases and the other in patients with known brain metastases. The trials were designed to explore the safety and pharmacokinetics of Azixa and to find the maximum tolerated dose of the compound.
Myriad reported that in the Phase I studies, Azixa appeared to have a biological effect on patients’ metastases from many different primary tumors, including non-small-cell lung cancer, which is consistent with the mechanism of the drug candidate.
“We are pleased at the clinical advancement Myriad has reported on Azixa, and view it as further evidence of the commercial potential of the compound,” stated Jack Talley, president and chief executive officer. “We believe that the study of Azixa in this new indication affords EpiCept with an expanded opportunity to capitalize on the financial benefits associated with our agreement with Myriad, including milestone payments, sublicensing income and potentially future royalties if Azixa continues to progress successfully.”