Lithera Successfully Completes Phase I Clinical Trial of LIPO-102
Published: Feb 09, 2010
SAN DIEGO, Feb. 9, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced the successful completion of a three-part Phase I clinical trial of LIPO-102 being developed for the treatment of thyroid-related (Graves' Disease) exophthalmos. LIPO-102 is a novel, minimally-invasive, non-ablative approach to localized fat reduction comprising an injectable aqueous combination of salmeterol xinafoate (SX) and fluticasone propionate (FP). This Phase I clinical study, carried out in abdominal adipose tissue serving as a surrogate for orbital adipose tissue, established the safety and pharmacokinetics of LIPO-102 at maximal doses within the 505(b)(2) threshold for a previously FDA-registered drug product. This trial also provided preliminary evidence of efficacy showing dose-related reductions in waist circumference measurements over the multiple dose part of the trial. A reduction of ~3 cm in mean waist circumference was observed (p=0.014).