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| |  CMV Retinitis Drug Delays Progression Of The Condition CARLSBAD, CA and ATLANTA, GA -- April 6, 1998 -- Study results from the Phase III clinical trials of Isis Pharmaceuticals’s fomivirsen, an intisense drug to treat cytomegalovirus (CMV) retinitis, an opportunistic infection that results in blindness in patients in AIDS, show that the drug produced prolonged delay in progression of the disease in both newly-diagnosed patients and patients with advanced disease The results, presented at the 11th International Conference on Antiviral Research, also showed that the drug produced similar median times to progression (71 days in newly-diagnosed patients, 90 days in patients with advanced disease). Fomivirsen also demonstrated an attractive safety profile in both populations. Fomivirsen is the first antisense drug to complete Phase III trials and to advance to a regulatory submission. Isis will submit the New Drug Application (NDA) to the Food and Drug Administration (FDA) shortly. CIBA Vision is the exclusive world-wide distributor for fomivirsen. In regimen A, patients were treated with one dose per week for three weeks (induction) followed by every other week dosing (maintenance). In regimen B, patients were treated at day 1 and at day 15 followed by monthly dosing. All patients were dosed at 330 micrograms. There were 54 patients in this trial, with 34 patients in regimen A and 20 patients in regimen B. Fomivirsen was well-tolerated in both dose regimens and displayed a similar efficacy profile in both treatment groups. The less intensive regimen displayed a more attractive safety profile. This study demonstrates that fomivirsen delays progression in patients with advanced disease and that the drug can be administered on a convenient once-per-month dosing schedule. In both regimens, the median time to observed progression was 90 days. The median time to disease response was also similar for the two groups: regimen A median response time was 7.8 days and regimen B median response time was 9.8 days. A similar study was conducted in Europe (CS12). When the results of the two studies are combined, the median time to observed disease progression was even longer (112 days for regimen A, 177 days for regimen B), with a similar safety profile. The results in CS9 compare favourably with published results from other studies in this patient population with standard antivirals (ganciclovir, cidofovir). The results also compare favourably with the results observed in Isis' CS2 trial. In that trial, the median time to disease progression for the fomivirsen treatment group was 71 days versus 13 days for the deferred treatment group. Taken together with the less frequent dose schedule and lack of systemic side effects, these results underscore the potential therapeutic benefit provided by fomivirsen in patients with refractory disease who have failed other therapies. More information on: Fomivirsen, and Isis Pharmaceuticals.
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