Medarex Announces Allowance of Investigational New Drug Application for Wholly Owned Fully Human Anti-CD70 Antibody, MDX-1411
Tuesday January 8, 7:00 am ET
PRINCETON, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1411 for the treatment of CD70-expressing malignancies, with the initial clinical study to focus on the treatment of clear cell renal cell carcinoma (ccRCC). MDX-1411 was generated by Medarex's UltiMAb Human Antibody Development System®.
The open-label, multi-center, dose-escalation, multi-dose Phase I clinical trial is expected to enroll up to 40 patients with advanced ccRCC. The trial is designed to determine the safety, tolerability and maximum tolerated dose of MDX-1411 as well as characterize preliminary efficacy and pharmacokinetics.
"The advancement of this antibody into the clinical trial process adds to our internal pipeline and expands our portfolio of potentially new oncology therapeutics," said Howard H. Pien, President and CEO of Medarex. "We expect the growth of our pipeline to continue through the addition of proprietary products along with new antibodies that are developed through collaborations."
About MDX-1411
MDX-1411 is a fully human monoclonal antibody that targets the CD70 receptor, which is a member of the tumor necrosis factor (TNF) family. CD70 is expressed in a number of cancers, including ccRCC primary tumors and metastatic lesions. Preclinical in vitro studies showed that MDX-1411 binds to CD70 positive cells and induces antibody-dependent cellular cytotoxicity (ADCC), an important mechanism of action of therapeutic antibodies that induces the destruction of targeted cells by the immune system. Preclinical in vivo studies conducted in ccRCC xenograft models demonstrated anti-tumor activity.
About Renal Cell Carcinoma (RCC)
According to the American Cancer Society there were almost 39,000 new cases of RCC and 13,000 deaths caused by RCC in 2006. About 80% of RCC cases are clear cell renal cell carcinoma making it the most common among five types of RCC. Renal cell carcinoma generally starts as one or more tumors in one or both kidneys and in advanced stages can spread to other organs. Current treatment options for RCC include surgery, radiation, chemotherapy, immunotherapy and targeted therapeutics. |
