EpiCept Corporation reported that Myrexis, Inc. has initiated a controlled two-arm phase II b clinical study of Azixa as a front-line treatment for Glioblastoma Multiforme (GBM). Azixa, a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of it’s ASAP technology platform and licensed to Myrexis.
The study will enroll up to 120 newly-diagnosed GBM patients at treatment centres 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 in this disease with standard of care in combination with Azixa.
“We are pleased that Myrexis is continuing to evaluate Azixa and that they continue to see promise for the compound in a devastating disease for which current therapy is inadequate,” said Jack Talley, president and chief executive officer of EpiCept. “We expect them to continue to move the product candidate forward towards registration in the United States.”
Azixa is currently being evaluated in other phase II trials. In June 2010, Myrexis reported results from two of the phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent Glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO). Updated results from an ongoing, open-label phase II a monotherapy study of Azixa in treatment-experienced patients with Glioblastoma Multiforme (GBM) were presented in November 2010, and data from a sub-group of patients with recurrent GBM who are naïve to Avastin is expected to be reported in the first half of 2011.
As one of the molecules within the EpiCept EP90745 series of apoptosis inducer compounds intended for the treatment of cancer, Azixa was discovered through the Company's Anti-cancer Screening Apoptosis Platform (ASAP). In December 2003, EpiCept granted an exclusive, worldwide development and commercialization agreement for the EP90745 series (which includes Azixa) to Myrexis, which assumed responsibility for the clinical development and commercialization of this series of compounds.
The license agreement requires Myrexis to make milestone payments and pay license fees as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series. The dosing of the first patient in a phase III or equivalent trial intended to be used for registration purposes for Azixa triggers a milestone payment to EpiCept.
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene, approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukaemia (AML) in first remission. In the US, a pivotal trial is scheduled to commence in 2011.
The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumours. The Company's pain portfolio includes EpiCept NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.