Tuesday October 6, 7:58 am Eastern Time
Company Press Release
XOMA In Collaboration With Genentech Completes
Phase II Enrollment for hu1124 Psoriasis Study
BERKELEY, Calif.--(BW HealthWire)--Oct. 6, 1998--XOMA Corporation (Nasdaq:XOMA - news) has completed
enrollment in a 149-patient randomized, placebo-controlled Phase II clinical study of the hu1124 monoclonal antibody in
moderate-to-severe psoriasis patients.
XOMA is developing the product (originally called anti-CD11a) in collaboration with Genentech, Inc. (NYSE:GNE - news).
Patients undergo an 8-week course of therapy with either the hu1124 product or placebo. The objective of the double-blinded
study is to determine clinical safety and efficacy under controlled conditions; the primary endpoint is clinical improvement.
Additional data related to extended exposure to hu1124 is also being collected.
Results of an earlier Phase IA open-label single-dose safety study in psoriasis patients showed that hu1124 was well tolerated
and that some patients improved, suggesting clinical activity. These results have been presented in various scientific meetings
since May 1998. Enrollment was also recently completed in a multiple-dose, dose-escalating Phase IB study in approximately
40 patients. Results of that study will be presented in a future scientific forum.
''We are pleased with the efficient manner in which our Canadian study centers have enrolled patients in the Phase II study,''
said Jack Castello, chairman, president and CEO of XOMA. ''Completing enrollment in this study keeps us on track to meet
our year-end goals for this collaboration with Genentech.''
Psoriasis is a chronic inflammatory skin disorder. There are 400,000 to 800,000 people in the United States with a moderate
to severe form of the disease. These patients suffer recurring bouts of skin inflammation characterized by the formation of red,
raised, scaly plaques.
T cells are specialized white blood cells (lymphocytes) mobilized by the immune system to destroy foreign cells. Abnormal T
cell function contributes to the development of psoriasis. This is shown by increased activation and migration of these cells in the
skin. T cell activation and migration also play an important role in rheumatoid arthritis, multiple sclerosis, and inflammatory
bowel disease.
Agents that inhibit T cell activation and migration can potentially treat a variety of inflammatory and autoimmune diseases by
reducing the immune response. The hu1124 product is a humanized monoclonal antibody engineered to selectively inhibit T
cells and therefore potentially block the pathologic immune reaction in psoriasis patients.
XOMA Corporation develops and manufactures genetically-engineered protein, peptide and monoclonal antibody
pharmaceuticals. XOMA's medical targets include systemic bacterial and fungal infections, infectious complications following
traumatic injury and surgery, and immunologic disorders. The company's primary drug development platform is BPI
(bactericidal/permeability-increasing protein), a protein in the human host-defense system with multiple anti-infective properties.
XOMA has leveraged its expertise in developing, manufacturing and clinically testing monoclonal antibodies into the
collaboration with Genentech to develop hu1124.
Statements made in this press release relating to the timing of clinical trials and other aspects of product development,
regulatory approvals, and plans for sales and marketing, 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.
Note to Editors: For a copy of this or other recent releases call: XOMA Fax News on Demand 800/901-7788 XOMA home
page at xoma.com |
