BGEN was up strongly on this psoriasis news:
Tuesday May 25, 6:51 pm Eastern Time
Biogen psoriasis drug to enter Phase III
NEW YORK, May 25 (Reuters) - Biogen Inc. (Nasdaq:BGEN - news) on Tuesday said it will begin a Phase III trial of its psoriasis drug Amevive, following positive results in an earlier study for safety and efficacy.
Cambridge, Mass.-based Biogen, said it will ''proceed aggressively'' with late-stage studies in North America and Europe, but did not specify a date.
The company declined to give specific results from the Phase II trial, in which patients received either a weekly injection of the drug or placebo for 12 weeks. But it said that Amevive, used in treating a moderate-to-severe form of the disease, ''showed excellent dose response and side-effect profile in a Phase II clinical trial.''
The Phase II study involved 229 patients in the United States with moderate-to-severe chronic plague psoriasis. That form of the disease affects about one million people in Europe and the United States.
Phase III trials are typically the final stage, before drugs are submitted for marketing approval with the U.S. Food and Administration. Phase III can involve thousands of patients.
Psoriasis is an inflammatory disorder characterized by red, scaly, thick plaques that can cause discomfort.
Amevive works by inhibiting the overactive immune system ''T cells'' that cause the disease. |