BW0076 JUL 07,1999 5:03 PACIFIC 08:03 EASTERN
& Medical Writers
Canadian Dermatology Association Meeting
NOTE TO MEDIA: Photo is available in a Smart News Release(TM) on Business Wire's Home Page at www.businesswire.com
BERKELEY, Calif.--(BW HealthWire)--July 7, 1999--A XOMA investigator has presented positive results from a Phase II clinical study of the hu1124 (antiCD11a) antibody product in moderate to severe psoriasis patients. The product is being developed under a collaboration between XOMA Ltd. (Nasdaq:XOMA) and Genentech, Inc. The data were presented for the first time by Kim Papp, MD, a study investigator, on July 2 at the Canadian Dermatology Association meeting in Vancouver, British Columbia.
"The data demonstrate that hu1124 shows significant activity in patients with moderate-to-severe plaque psoriasis," said Dr. Papp, Clinical Investigator at Probity Medical Research in Ontario. "These results are further evidence that this compound may inhibit the inflammatory process in psoriasis without depleting T cells and suppressing the immune system."
The Phase II placebo-controlled, randomized, double-blinded study tested the hu1124 product in 145 moderate-to-severe psoriasis patients who underwent a course of eight weekly doses of either the study drug or placebo. The study objectives were to determine clinical safety at multiple doses and the potential effects of treatment on severity of psoriasis as compared with placebo. The study, conducted in Canada, completed accrual at the end of September 1998. Patients were evaluated 56 days after beginning treatment, which was seven days following the last dose, with additional follow-up at 91 and 140 days.
Analysis of data from the study showed that 48% of patients treated with the 0.3 mg/kg dose of the product showed a Physician's Global Assessment (PGA) score at 56 days of 50% or greater improvement ("good" or better) compared with 15% of placebo patients (p = 0.0002, Fisher's Exact test) and 25% had a PGA score of 75% or greater improvement ("excellent") compared with 2% of the placebo group (p = 0.0004). On the whole, the drug appeared to be well tolerated. The most common adverse events were mild headaches and low-grade fever, particularly after the first dose.
Psoriasis in its various forms is one of the most common skin diseases worldwide. In North America and Europe up to a million people may be affected by the more severe forms of the disease. People with moderate-to-severe plaque psoriasis suffer chronic or recurring bouts of skin inflammation characterized by an accumulation of abnormally fast-growing keratinocyte skin cells that result in red, raised, scaly plaques.
Psoriasis is now considered to be a T cell-mediated chronic inflammatory disorder. T cells are specialized white blood cells mobilized by the immune system to destroy foreign cells. In psoriasis, increased activation, adhesion and migration of T cells into the skin contribute to the inflammation and abnormal keratinocyte proliferation. Misdirected T cell activities also play an important role in other autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.
XOMA Ltd. develops and manufactures biopharmaceuticals at facilities located in Berkeley and Santa Monica, California. The company's medical targets include bacterial and fungal infections, infectious complications (such as those that may follow trauma or surgery), immunologic and inflammatory disorders.
Statements made in this press release related to the timing of clinical trials, release of data and other aspects of product development, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions which may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the timing or results of pending or future clinical trials, changes in the status of the Company's collaborative relationships, uncertainties regarding the legal standards applicable to biotechnology patents, and actions by the U.S. Food and Drug Administration or the U.S. Patent and Trademark Office, are discussed in the Company's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in evaluating XOMA's prospects.
Ellen M. Martin, 510/644-1170 or 800/BIO-XOMA
Juliane Snowden, 212/510-9286
Tariq Jawad, 212/510-9346