Two local drug development companies are seeking approval to start new rounds of clinical trials — one, here in Madison, and the other, across the globe.
Cellectar Biosciences wants to test its lead drug candidate, CLR 131, on children and teens with a variety of cancers. The Madison biopharmaceutical company has filed an investigational new drug application with the oncology division at the U.S. Food and Drug Administration to see if CLR 131 can help young people with certain rare cancers.
The first phase would involve giving a single, intravenous dose of CLR 131 to up to 30 children and adolescents with cancers that could include neuroblastoma, sarcomas, lymphomas and malignant brain tumors to check for the safety and tolerability of the drug and to see if there’s any preliminary effect on the cancer.
If it’s approved, the study will be conducted at the UW Carbone Cancer Center.
“Together, our hope is to bring new and effective treatment options for children battling life-threatening cancers,” said Cellectar’s chief medical officer John Friend.
Cellectar said CLR 131 targets cancer cells and delivers radiation to them, minimizing exposure to normal tissue. The company said animal studies of CLR 131 against several types of solid tumors have shown “significant benefits on tumor growth rates and survival.”
The drug compound already is being evaluated in two studies involving adult patients. One is for adults with multiple myeloma, a cancer of the plasma cells. It will test up to 40 patients at 10 leading cancer centers around the U.S.
Cellectar, founded in 2002, has about 15 employees.
Liver disease to be focus of trials
Arrowhead Pharmaceuticals is asking for the OK to start the first human clinical trials of its drug compound, ARO-AAT for treating adults with alpha-1 liver disease. It is Arrowhead’s second-generation drug candidate for the disease, which is a hereditary disorder.
Arrowhead submitted its application to New Zealand’s Medicines and Medical Devices Safety Authority.
Arrowhead is based in Pasadena, California, but its research and development team is located in Madison. The company is working on a series of drugs, based on RNA interference, to combat a range of diseases.