Clinical improvement in adenoviral conjunctivitis model

July 15, 2009

Foresight Biotherapeutics, Inc. has announced data from a pre-clinical study designed to assess the safety and efficacy of the topical administration of FST-100 in a highly regarded Ad5 NZW rabbit model of adenoviral conjunctivitis.

Foresight Biotherapeutics, Inc. has announced data from a pre-clinical study designed to assess the safety and efficacy of the topical administration of FST-100 in a highly regarded Ad5 NZW rabbit model of adenoviral conjunctivitis. FST-100 demonstrated a clinically and statistically significant reduction in signs of adenoviral conjunctivitis versus all other groups including the current experimental "gold standard," topical cidofovir. The study was conducted at the Louisiana State University (LSU) Health Science Center, LSU Eye Center in New Orleans, Louisiana by Professor James M. Hill and colleagues, in the Departments of Pharmacology, Microbiology, Ophthalmology and Neuroscience.

The randomized controlled study was conducted in 40 eyes of 20 rabbits experimentally inoculated with human adenovirus type 5. The study was designed to investigate the safety and efficacy of topically administered FST-100 compared to both active controls and to placebo. Animals were randomized 1:1:1:1 (5 rabbits per group) to FST-100, topical 0.5% cidofovir, Tobradex(tobramycin/dexamethasone) ophthalmic suspension and placebo. Treatment began one day after viral inoculation and continued for eight days. Eyes were scored daily for clinical parameters including conjunctival inflammation, fragility of ocular blood vessels, purulent discharge, eyelid inflammation, and excessive tearing. Daily viral titer data using a plaque reduction assay are currently undergoing analysis.

The study concluded that FST-100 was superior to all other arms of the study. Dramatic clinical improvement was seen in some treated rabbits as early as 48 hours after the first dose of FST-100.

Complete clinical resolution was observed in all FST-100 treated eyes. No other group reached complete clinical resolution. Specifically, treatment with cidofovir, Tobradex or placebo resulted in injected and inflamed corneas, eyelid and conjunctival inflammation and injection with sub-conjunctival haeme.

Professor Hill said in a statement: "This set of data using FST-100 in this very challenging animal model of adenoviral conjunctivitis is highly encouraging. Specifically, no other drug that I have tested has provided such dramatic clinical efficacy, indicating that further studies in human adenoviral conjunctivitis are certainly warranted."