KaloBios Completes Meeting with FDA for Benznidazole
BRISBANE, Calif., Dec. 12, 2016 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, announced that the company recently completed a face-to-face meeting with U.S. Food and Drug Administration (FDA) to review its proposed development plans for benznidazole in the treatment of Chagas disease, a neglected tropical disease.
With the meeting, FDA’s Division of Anti-Infective Products addressed the company’s questions and provided guidance on preparation of an acceptable package for benznidazole.
"Our meeting with FDA was productive with regard to our regulatory path forward for benznidazole in Chagas disease," said Cameron Durrant, MD, KaloBios chairman and CEO. "We are encouraged by the helpful responses and look forward to further collaborative engagement.”
Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan parasite Trypanosoma cruzi carried and transmitted by triatomine insects (often called “kissing bugs”). According to the Centers for Disease Control and Prevention (CDC), an estimated 300,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. Benznidazole is the current preferred treatment for Chagas disease in other parts of the world but is not currently approved by the FDA in the U.S. Legislation is in place to incentivize companies to bring treatments to the U.S. market for certain neglected tropical diseases, including Chagas. If approved, benznidazole could be eligible to receive a priority review voucher.
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTC: KBIO) is an emerging biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios portfolio are benznidazole for the potential treatment of Chagas disease in the U.S., and the proprietary monoclonal antibodies, lenzilumab and ifabotuzumab (formerly KB004), for the potential treatment of various solid and hematologic cancers such as CMML and potentially JMML. For more information, visit www.kalobios.com.
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Released December 12, 2016