PRINCETON, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug (IND) application filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company's first Antibody-Drug Conjugate (ADC) candidate generated from its proprietary technology. MDX-1203 is comprised of a potent cytotoxic prodrug chemically linked with a fully human anti-CD70 antibody. CD70 is expressed in renal cell carcinoma (RCC), leukemias, lymphomas, and other cancers. The Phase 1 study will evaluate MDX-1203 for the treatment of advanced/recurrent RCC and relapsed/refractory B-cell non-Hodgkin's lymphoma (NHL).
"Antibody-drug conjugates are another important and innovative therapeutic approach used to fight cancer by effectively and selectively killing tumor cells over-expressing specific tumor antigens, so we are extremely excited in achieving the IND filing for MDX-1203, the first candidate from our proprietary ADC technology platform," said Howard H. Pien, Chairman and CEO of Medarex. "We developed our ADC technology to have significant competitive advantages over existing technologies and the Phase 1 trial for MDX-1203 will be the first study to evaluate these potential benefits."
An open-label, multi-dose, dose-escalation Phase 1 clinical trial will be conducted in patients with RCC and NHL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary distribution, metabolism and pharmacokinetics of MDX-1203.
About Medarex's Antibody-Drug Conjugate (ADC) Technology
Medarex has enhanced its core UltiMAb(R) antibody platform with a suite of technologies that optimize or augment the therapeutic activity of antibodies, and one important technology expansion is the company's pr
|SOURCE Medarex, Inc.|
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