Plexxikon Inc. announces that enrollment has been initiated and the
first patient has been dosed in a pivotal Phase 3 trial of PLX4032
(RG7204) in patients with metastatic melanoma. PLX4032 is a novel, oral
and highly targeted drug that is designed to inhibit the BRAF
cancer-causing mutation that occurs in about 50 percent of
melanomas and about eight percent of all solid tumors. The randomized,
controlled, Phase 3 “BRAF Inhibitor in Melanoma” (BRIM3) trial in
previously untreated patients is part of the planned registration
program for PLX4032. The initiation of the Phase 3 trial has triggered a
significant milestone payment to Plexxikon from Roche, its
co-development partner, under their 2006 collaboration agreement.
Plexxikon also is entitled to receive additional payments for further
milestone achievements as well as royalties on sales of PLX4032. A Phase
2 trial (BRIM2) in previously treated melanoma patients was initiated in
September 2009, with enrollment ongoing.
“We are
hopeful that this accelerated development program will enable us to
bring this new personalized medicine to melanoma patients as quickly as
possible. PLX4032 represents the first drug in Plexxikon’s promising
franchise of oncology drug candidates.”
“With some tumor shrinkage in nearly all mutation-positive melanoma
patients, and 70 percent of patients achieving at least 30 percent tumor
shrinkage in our most recent clinical study, PLX4032 has shown
meaningful anti-tumor activity. The Phase 3 trial, with a primary
endpoint of overall survival, will provide an assessment of clinical
benefit of PLX4032 in a randomized, controlled study design, which
should further build our registration program for this drug,” stated K.
Peter Hirth, Ph.D., chief executive officer of Plexxikon. “We are
hopeful that this accelerated development program will enable us to
bring this new personalized medicine to melanoma patients as quickly as
possible. PLX4032 represents the first drug in Plexxikon’s promising
franchise of oncology drug candidates.”