Theraclone initiates TCN-032 Phase 1 trial in influenza A

Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, announced today first dosing of subjects in a Phase 1 clinical trial of TCN-032, a broadly protective, fully human monoclonal antibody for the treatment of influenza A virus. This trial is supported in part by Theraclone's multi-year research and development agreement with Zenyaku Kogyo Co., Ltd. to identify conserved, essential antibody targets and develop candidates for the treatment of pandemic and severe seasonal influenza. TCN-032 was discovered using Theraclone's I-STAR™ platform.

"I-STAR™ has repeatedly demonstrated a unique ability to identify natural human antibodies with exceptionally broad biologic activity and therapeutic potential," said Steven Gillis, Ph.D., Executive Chairman and acting CEO of Theraclone Sciences. "The initiation of this study is an important milestone on the path to a novel biologic for either prevention or treatment of influenza A, which remains a major threat to global public health."

"Influenza presents a recurring challenge because of the unpredictable nature of the virus. Worldwide, influenza may lead to several hundred thousand deaths annually. TCN-032 is a potential universal treatment that may provide protection from a broad spectrum of influenza A strains," commented Eleanor Ramos, M.D., Chief Medical Officer of Theraclone Sciences.

"Zenyaku Kogyo is committed to develop novel therapeutics to improve human health. Through TCN-032, we hope to provide benefits to patients at high risk for influenza infection and its complications," said Kazuhiro Hashimoto, Chairman of Zenyaku Kogyo Company, Ltd. "We are excited to see the first candidate from our collaboration with Theraclone enter clinical development."

The randomized, double-blind Phase 1 dose-escalation trial in healthy adult volunteers will assess the safety profile of a single intravenous administration of TCN-032 compared to placebo. The study will enroll 40 volunteers at a single U.S. site and will also provide pharmacokinetic and immunogenicity data. Study results are expected in the first half of 2012 and are a pre-requisite for commencement of proof of concept clinical trials.

Zenyaku Kogyo has an exclusive license in the territory of Japan to Theraclone's influenza monoclonal antibody program. Theraclone retains worldwide development and commercialization rights outside of Japan.