Clinical data from two separate Phase 2a combination drug studies of Azixa presented at ASCO 2010

Jun 8 2010

Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) today announced the presentation of clinical data from two separate Phase 2a combination drug studies of Azixa^TM (MPC-6827, verubulin) at the American Society of Clinical Oncology 2010 Annual Meeting in Chicago, IL. Results from studies in both recurrent glioblastoma multiforme (GBM) and stage 4 metastatic melanoma demonstrated that Azixa, in combination with standard treatments, resulted in durable responses with no added toxicity compared with chemotherapy alone. 

"We are very encouraged by the duration and frequency of responses seen in patients treated with Azixa in both GBM and metastatic melanoma," said Dr. Adrian Hobden, President and CEO of Myriad Pharmaceuticals. "Based on the activity of Azixa seen in these studies of very difficult-to-treat diseases and the observation that Azixa administered in combination with standard chemotherapeutic regimens did not result in increased toxicity when compared to chemotherapy alone, we are planning to expand the clinical program for Azixa."

In a poster presentation on Sunday, June 6, entitled "A clinical study investigating MPC-6827 with carboplatin in the treatment of patients with relapsed glioblastoma multiforme", data were presented from the Phase 2a that enrolled 19 patients with GBM and were treated with carboplatin and one of three doses of Azixa. All patients had failed previous treatment with temozolomide. In the GBM study, 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 is, as of today, 16 months in duration and has been classified by his physician as almost a complete response.  The overall response rate was 42% as defined by partial response and stable disease evaluated using MacDonald criteria. The combination of Azixa at all three concentrations with a fixed dose of carboplatin, including the previously determined single agent maximum tolerated dose of Azixa, was safe and well-tolerated. A dose reduction of Azixa was not required when combined with carboplatin in these patients. Additional data collection is ongoing in this study.

In a poster presentation entitled "Final report: MPC-6827 is safely combined with temozolomide for the treatment of patients with metastatic melanoma", Myriad Pharmaceuticals reported final data from the Phase 2a study enrolling 22 patients with Stage 4 metastatic melanoma. In this study, two patients achieved partial response durations of four and 10 months. Nine patients experienced stable disease durations between three and seven months. The response rate (defined as partial response by modified RECIST criteria and stable disease) was 50% and the median progression free survival (PFS) of patients in the metastatic melanoma study was 2.9 months. These PFS data compare favorably to temozolomide and dacarbazine in a randomized Phase 3 study for the treatment of patients with advanced metastatic malignant melanoma (PFS of 1.9 and 1.5 months, respectively; J Clin Oncol 18:158-166, 2000).  The combination of the drugs was shown to be safe and well tolerated at all combinations in this study. A dose reduction of Azixa was not required when combined with temozolomide in these patients.