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ESBATech's Antibody Fragment Enters Phase Ib/IIa in Ophthalmology
Date:2/3/2009

Topical Delivery of ESBA105, an Anti-TNF Alpha Antibody Fragment in Patients Undergoing Cataract Surgery

ZURICH, Switzerland, Feb. 3 /PRNewswire/ -- ESBATech AG, a leading developer of antibody fragment therapeutics, today announced the initiation of a Phase Ib/IIa study in patients undergoing cataract surgery. This study is designed to evaluate the safety, tolerability, and ocular pharmacokinetics (PK) of topically applied ESBA105 in patients, as well as assess the preventive activity on ocular inflammation resulting from the surgery. ESBA105 is a single-chain antibody fragment directed against TNF-alpha, a major mediator of inflammation. The study contains a randomized, double-blind, placebo controlled part and is being conducted as a monocentric trial in Switzerland.

The primary objectives of this study are to assess the local tolerability and safety of topical ESBA105 as well as to evaluate its intraocular levels and local biodistribution in the human eye. Secondary objectives include the assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.

Michael A. Thiel, M.D., Ph.D., principal investigator of this study and head of the Department of Ophthalmology at the Kantonsspital in Lucerne, Switzerland, commented, "Our team has previously published the basic feasibility of applying single-chain antibody fragments to the eye. With ESBA105, the people from ESBATech have introduced for the first time a single-chain antibody fragment that carries all necessary characteristics for clinical use. I look forward to the evaluation of ESBA105 in this human PK study."

Dominik Escher, Ph.D., Chief Executive Officer of ESBATech AG, added, "Progress has been lacking in the development of novel treatments for inflammatory ocular conditions. We are very pleased to advance our compound into clinical Phase Ib/IIa, o
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