From the June 23 press release:
Psoriasis and Breast Cancer Trials
Ligand is also conducting a multicenter dose-ranging (0.5 milligram per kilogram to 3 milligram per kilogram per day) Phase II trial with Targretin capsules for the treatment of patients with moderate to severe plaque psoriasis, a condition that is estimated to affect between 1.4 and 1.9 million people in the U.S. To date, 34 patients have been enrolled at four study centers in The Netherlands and Belgium in this open-label study. An interim assessment of the first two dose panels, based on 12 patients in each panel, has revealed encouraging evidence of efficacy, with at least a two-grade improvement (on a nine-grade scale) in plaque elevation in up to 67% of patients, at least 50% improvement in Psoriasis Area and Severity Index (PASI) scores in up to 33% of patients, and at least 50% improvement according to a Physician's Global Assessment in up to 42% of patients. Encouraging interim results to date have led Ligand to explore further the therapeutic index profile in two additional dose level panels (one low and one high dose) in order to determine the optimal dose regimen. Targretin capsules have been generally well tolerated by patients with psoriasis, with a 17% rate of withdrawal due to treatment-related adverse events before completion of the 24-week treatment duration.
The most common adverse events are hypertriglyceridemia and mucocutaneous dryness. Additional results are expected during the second half of 1999.
As a result of the positive findings from multiple pre-clinical studies, in November 1998, Ligand launched a human Phase II clinical trial of Targretin capsules for the treatment of women with advanced breast cancer. Interim results are expected in the second half of 1999 from this ongoing clinical trial. Data from pre-clinical studies have shown that Targretin caused complete and partial regression of breast cancer tumors that grew despite tamoxifen therapy. Tamoxifen is currently the most widely prescribed hormonal breast cancer therapy. This year, experts predict that more than 180,000 cases of breast cancer will be diagnosed, making it the most common non-skin malignancy in the U.S. among women. The prevalence of breast cancer in the U.S. is estimated to have reached more than 2 million. |
