AstraZeneca, Array begin phase 2 studies of melanoma treatment

By E. Janene Geiss

Philadelphia, June 8 - AstraZeneca and Array BioPharma Inc. announced Thursday the start of a phase 2 study for AZD6244 in malignant melanoma.

AZD6244 is a selective MEK inhibitor that was in-licensed by AstraZeneca from Array in December 2003, according to a company news release.

AstraZeneca said it expects the first patient to be enrolled in this melanoma study before the end of June, which will trigger a $3 million milestone payment to Array upon dosing the first patient.

The trial is a randomized phase 2 study that will compare AZD6244 to temozolomide in the treatment of stage 3 and 4 melanoma.

AstraZeneca said it expects to enroll up to 180 patients at about 40 centers worldwide.

Additional phase 2 studies, in a range of other tumors, are scheduled to start over the next two to three months.

The company said it believes AZD6244 will be the first MEK inhibitor to be evaluated in randomized phase 2 studies.

Initiation of the study is based on the results of the phase 1 study that recently completed recruitment and which included patients with melanoma and a variety of other solid tumors.

The phase 1 study clearly demonstrated that AZD6244 inhibits MEK and associated downstream markers in tumors at doses deemed well-tolerated. The full results of this study will be published later in the year, officials said.

Array said it was responsible for filing the Investigational New Drug application and conducting the phase 1 clinical testing of AZD6244. AstraZeneca said it is responsible for all other aspects of clinical development and commercialization.

As part of the collaboration, AstraZeneca acquired exclusive worldwide rights to AZD6244 and certain second-generation compounds for all oncology indications in December 2003.

Array said it retains the rights to all therapeutic indications outside of oncology for compounds not selected by AstraZeneca as part of the collaboration.

AstraZeneca is a London pharmaceutical and health care services company.

Array is a Boulder, Colo., biopharmaceutical company.

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