Plexxikon today announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival compared to patients treated with dacarbazine, the current standard of care.
Recently, Plexxikon announced its agreement to co-promote PLX4032 in the U.S. with Genentech, and is planning to begin building its commercial organization and sales force this year. PLX4032 is being co-developed with Roche, and now Genentech, a member of the Roche Group, under a 2006 license and collaboration agreement between Plexxikon and Roche. The companies plan to file for marketing approval with the health authorities in the U.S. and in Europe for PLX4032, and for its companion diagnostic, in 2011.
Combination trials with PLX4032, as well as trials in other BRAF-mutated cancers, are also planned.
In other recent news, the U.S. Patent and Trademark Office issued Plexxikon’s U.S. Patent No. 7,863,288, covering composition-of-matter claims for PLX4032 and providing a patent term until 2029. The accelerated development of a personalized medicine such as PLX4032 not only provides patient access to new medicines more quickly, but also maximizes patent life, thereby contributing substantive value to the program. The new U.S. patent further broadens Plexxikon’s intellectual property portfolio.
Source: Plexxikon Inc