AREVA Med Initiates Phase 1 Clinical Trial of ²¹²Pb-TCMC-Trastuzumab in Patients with HER-2 Positive Intra-abdominal Cancers
August 04, 2011
August 4, 2011
AREVA announced that its subsidiary AREVA Med has started a Phase 1 clinical trial for its lead product ²¹²Pb-TCMC-Trastuzumab in patients with HER-2 positive intra-abdominal cancers.
The new trial (AREVAMED01) is an open label Phase 1, dose escalation study of ²¹²Pb-TCMC-Trastuzumab (©Genentech’s commercially approved Herceptin® antibody labeled with lead-212 or ²¹²Pb) in up to 36 patients and will be conducted at the University of Alabama at Birmingham (UAB) Comprehensive Cancer Center. The trial will evaluate the product’s toxicity profile, dose-limiting toxicities, and anti-tumor effects in patients with HER-2 positive intra-abdominal cancers. Each patient will be administered with a single intravenous injection trastuzumab (Herceptin®) followed by a single intraperitoneal injection of ²¹²Pb-TCMC-Trastuzumab.
The principal investigator of the trial at the UAB, Ruby Meredith, M.D., Ph.D., said: "We are looking forward to starting this important clinical trial, targeting several very aggressive types of abdominal cancer.”
Patrick Bourdet, President and CEO of AREVA Med, said: "After several years of intense work and multiple innovations, we are delighted to begin this important U.S. trial with our alpha emitting ²¹²Pb, and to be working with the UAB, one of the leading cancer centers for radioimmunotherapy. This U.S. clinical trial is a major milestone in the clinical development of radioimmunotherapy and new treatments using AREVA Med’s ²¹²Pb, and a tribute to our historical partner, the U.S. National Cancer Institute (NCI) and its Radioimmune Inorganic Chemistry Section (RICS). We hope this clinical trial will contribute to numerous innovative therapies to combat cancer."
Monoclonal antibodies can deliver radioactive elements capable of destroying tumor cells. In this clinical trial, alpha radioimmunotherapy will be studied as a potential treatment for metastatic diseases using lead-212 (²¹²Pb), a radioisotope with a short path length targeting malignant cells thanks to the trastuzumab antibody.
August 4, 2011