Medarex Announces Clinical Development Milestone Achieved by ImClone Systems for Fully Human Antibody for the Treatment of Cancer
Wednesday January 3, 4:00 pm ET
Phase I Clinical Trial is Currently Underway
PRINCETON, N.J., Jan. 3 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced that it received a milestone payment from its licensing partner, ImClone Systems Incorporated, following the acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for IMC-3G3, a fully human antibody that targets platelet-derived growth factor receptor alpha (PDGFRa) for the treatment of cancer. The antibody product was developed using Medarex's UltiMAb® technology and is the second UltiMAb-derived antibody in clinical development by ImClone Systems. Medarex may receive future milestone payments and royalties should this product candidate progress through clinical development and to the market.
The Phase I clinical trial is currently underway and is designed to establish and evaluate the safety profile, pharmacokinetics and pharmacodynamics of IMC-3G3 administered weekly by intravenous infusion. The study is expected to enroll 30 to 40 patients with solid tumors at two clinical sites in the United States. According to ImClone Systems, data from preclinical animal models indicate that binding PDGFRa with IMC-3G3 results in reduction of cancer cell proliferation and tumor growth.
"We are pleased with the steady progress our partner, ImClone Systems, continues to make with Medarex's UltiMAb technology," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex. "We believe that this clinical development milestone is another demonstration of the broad applicability and appeal of our antibody technology for generating and developing potentially important new therapeutics." |
