Isis Pharmaceuticals Reports Phase II Study Results Of Topical Alicaforsen, ISIS 2302, in Psoriasis
CARLSBAD, Calif., Feb 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- In a Phase II clinical trial of patients with mild to moderate plaque psoriasis, a topical formulation of alicaforsen (ISIS 2302) demonstrated a statistically significant improvement in Investigator's Global Response Score (IGRS) at week four (p=0.02) and a positive trend toward improvement at week eight (p=0.206). IGRS is a subjective 0-5 point scale of disease improvement. Additionally, alicaforsen achieved a 31 percent improvement from baseline measurement in plaque induration, or thickness, at both weeks four and eight. This effect was statistically significant (p=0.013 and p=0.034, respectively), and confirmed trends observed in a prior study. There were no significant adverse events observed in the trial. Alicaforsen drug concentrations observed in skin biopsies also correlated with dose regimen, supporting the potential of antisense topical drugs to treat diseases of the skin. The results of this study were presented in a poster this weekend at the 60th Annual Meeting of the American Academy of Dermatology in New Orleans. As part of its dermatological drug discovery program, Isis Pharmaceuticals, Inc. (Nasdaq: ISIS chart, msgs) is also developing a topical formulation of ISIS 104838, a second-generation antisense inhibitor of TNF-alpha, in psoriasis.
The double-masked, paired-plaque Phase II clinical trial compared four percent topical alicaforsen cream to placebo in 31 patients with mild to moderate plaque psoriasis. In the study, patients applied alicaforsen or placebo to each of two matched psoriatic plaques. Fifteen patients in the study applied the creams once per day. Sixteen patients applied the creams twice per day. Patients were dosed for eight weeks and followed for twelve weeks. Biopsies of plaques from six patients were taken to evaluate the pharmacokinetic properties of alicaforsen. Other endpoints in the study included scaling and erythema, or redness.
"We are encouraged to have observed evidence of activity of topical alicaforsen in psoriasis in two studies. In this latest clinical trial, the drug produced statistically significant reduction in induration and modest therapeutic benefit," said F. Andrew Dorr, M.D., Isis' Vice President and Chief Medical Officer. "Additionally, the drug was very well tolerated, demonstrating that topical antisense drugs may be of value in treating dermatological diseases. We will continue to evaluate the role of ICAM-1 in psoriasis and other skin diseases such as atopic dermatitis. We will also consider future trials to evaluate alicaforsen in combination with other psoriatic medications or in other skin diseases as part of our overall drug discovery and development program in dermatology." |
