"Control" Of CMV Retinitis With Isis Drug

24 February 1997

Isis Pharmaceuticals has reported interim data from an ongoing PhaseIII trial which demonstrates that its antisense drug fomivirsen (ISIS 2922) has a good safety profile and produces rapid and long-term control of cytomegalovirus retinitis in AIDS patients. Data were presented at the IBC meeting on Antisense Therapeutics in San Diego on February 6.

The open-label, uncontrolled trial included patients who had failed with standard therapies, as well as the new CMV retinitis agents such as Chiron's intraocular ganciclovir implant Vitrasert and Gilead Science's Vistide (cidofovir injection). Fomivirsen-treated patients achieved progression-free periods of 12-18 months, although all patients were at an advanced stage of the disease. No systemic side effects have been recorded, says the company. Isis anticipates that Phase III trials will be completed later this year.

ISIS 2302 In Crohn's Disease Isis will also start a Phase IIb large-scale pivotal study with ISIS 2302 in Crohn's disease in the early second-quarter, it reports, following positive efficacy data from its recently-completed Phase IIa study, which will be released towards the end of February. Phase II clinical trials with ISIS 2302, an antisense inhibitor of ICAM-1 gene expression, in ulcerative colitis, rheumatoid arthritis, psoriasis and kidney transplant rejection, are also being conducted.

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