Cancer Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Cancer Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Prostate Cancer
OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011
July 29th, 2008
OncoGenex Technologies Inc. announced that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate cancer, via the Special Protocol Assessment (SPA) process. In the letter responding to the OncoGenex submission, the FDA stated that they agreed with the design and planned analysis proposed by OncoGenex, and that the study design adequately addresses the objectives necessary to support a regulatory submission. The Phase 3 trial has been designed in collaboration with internationally recognized experts in the treatment of...
Source: Cancer Weekly (2008-07-29)
|
