XOMA: GOOD RESULTS IN PSORIASIS
Date: 05 Mar 2001
Results from two clinical studies in moderate-to-severe plaque psoriasis patients.
IN THE FIRST STUDY:
Patients treated with Xanelim(TM) (efalizumab) for 12 weeks.
RESULTS : Significant improvement in psoriasis symptoms.
IN THE SECOND STUDY:
Psoriasis patients retreated with a second course of Xanelim(TM), also known as anti-CD11a.
RESULTS: Patients achieved symptom improvements similar to the first course of treatment.
Study data were presented at the 59th Annual Meeting of the American Academy of Dermatology (AAD).
Genentech, Inc. (NYSE:DNA - news) and XOMA are co-developing Xanelim(TM) for moderate-to-severe plaque psoriasis and kidney transplant rejection.
PHASE I/II SUBCUTANEOUS TREATMENT STUDY
In a Phase I/II open-label study, a group of 61 patients with moderate-to-severe plaque psoriasis were given an initial subcutaneous conditioning dose of 0.7 mg/kg of Xanelim(TM), followed by 11 weekly subcutaneous treatments of 1 mg/kg (n=20), 2 mg/kg (n=20) or 4 mg/kg (n=21).
The primary response measure was change in PASI (Psoriasis Area and Severity Index) scores between Day 0 and Day 84.
RESULTS: Overall, 75% (46/61) of patients given Xanelim(TM) achieved 50% or better PASI improvement at Day 84, and 31% (19/61) achieved 75% or better improvement.
In an additional evaluation, pharmacokinetic and pharmacodynamic analysis showed similar effects from the subcutaneous delivery of Xanelim(TM) compared with an intravenous formulation, and study doses maintained sufficient drug levels to achieve reduced CD11a expression and binding site saturation during the treatment period.
Xanelim(TM) was well tolerated in a majority of patients in the study. The most commonly observed adverse events were headache, flu-like symptoms, and psoriasis symptoms after completion of treatment. No serious adverse events were reported in the study.
``The improvement seen in study patients receiving Xanelim(TM) is very encouraging,'' said Craig Leonardi, M.D., study investigator with Radiant Research in St. Louis. ``These findings are consistent with the efficacy and tolerability seen in previous studies. In current Phase III trials, treatment may be given in the doctor's office or self-administered at home, providing potential added convenience for psoriasis patients.''
Xanelim(TM) Re-treatment Trial
Researchers also presented preliminary results from a 12-week open-label study running in parallel to the Phase III program that re-treated patients who received IV or subcutaneous Xanelim(TM) in Phase I or II clinical studies. Patients in the re-treatment study received an initial subcutaneous conditioning dose of 0.7 mg/kg of Xanelim(TM) followed by 11 weekly subcutaneous doses of 1.0 or 2.0 mg/kg. Some patients received topical steroids, calcipotriene or UVB phototherapy concurrently with Xanelim(TM) treatment. Patients also were given the option of at-home administration. The primary measure of response was change in PASI scores between Day 0 and Day 84.
In a preliminary analysis of 50 patients, the study found a second course of therapy exhibited similar efficacy rates to the first course of therapy as measured by PASI. In all, almost 80% of patients achieved a comparable or better PASI score at the end of the second course of treatment compared to the first course of treatment.
At the end of treatment, 28% (14/50) of patients achieved 75% or better PASI improvement, and 58% (29/50) achieved 50 percent or better improvement.
Xanelim(TM) was well tolerated by most patients in the study.
The most commonly observed adverse events were headache, rhinitis and other aches and pains.
No serious adverse events were reported in the 50 study patients; further safety findings will be available upon completion of Phase III studies and presented at a future scientific meeting.
Xanelim(TM) and Psoriasis Background
Xanelim(TM) is currently in Phase III development for the treatment of moderate-to-severe plaque psoriasis and in Phase I/II for kidney transplant rejection. Xanelim(TM) is a non-T-cell depleting monoclonal antibody against the CD11a chain of LFA1, a lymphocyte co-stimulatory adhesion molecule. Xanelim(TM) is designed to inhibit the binding of T-cells to other cell types and targets three key processes in the cascade of events that lead to psoriasis that may be linked to the abnormal growth of skin cells and the painful, elevated scaly patches of skin (lesions) typical among psoriasis sufferers. These are: (1) T-cell binding through interactions with adhesion molecules on the endothelial cell surface; (2) trafficking of T-cells into the skin; (3) activation of T-cells.
Psoriasis is a chronic autoimmune disease of the skin that affects more than 7 million Americans (about 2.6% of the U.S. population). Many patients require long-term therapy to treat its symptoms. According to the National Psoriasis Foundation, psoriasis occurs when new skin cells grow abnormally, resulting in inflamed, swollen, and scaly patches of skin where the old skin has not shed quickly enough. Plaque psoriasis, the most common form, is characterized by inflamed patches of skin (``lesions'') topped with silvery white scales. Psoriasis can be limited to a few plaques or can involve moderate to extensive areas of skin, appearing most commonly on the scalp, knees, elbows and trunk. Psoriasis can be a physically and emotionally painful condition. It often results in physical limitations and disfigurement. Managing the daily care of the disease can be a significant burden to patients. Although it is highly visible, psoriasis is not a contagious disease.
There is no known cure.
XOMA develops and manufactures antibody and other protein biopharmaceuticals for disease targets that include immunological and inflammatory disorders, infectious diseases and cancer. Late-stage programs include the collaboration with Genentech, Inc. to develop the Xanelim(TM) antibody product for psoriasis (Phase III) and kidney transplant rejection (Phase I/II), and an agreement with the Hyland Immuno Division of Baxter Healthcare Corporation to develop NEUPREX® (a systemic formulation of rBPI-21) for multiple indications. Earlier stage products include: ING-1, a Human Engineered(TM) antibody now in Phase I studies for cancer; Genimune(TM), a Human Engineered(TM) antibody-based immunofusion product in preclinical development for autoimmune diseases and immunological cancers; Mycoprex(TM), a compound in preclinical development for the treatment of fungal infections; and antiangiogenic compounds for retinal disorders. For more information about XOMA's pipeline and activities, please visit XOMA's web site at www.xoma.com.
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Statements made in this news release related to collaborative agreements and current plans for 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 that 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 changes in the status of the Company's collaborative relationships, the timing or results of pending or future clinical trials, market demand for products, and marketing obligations of the collaborators and other partners, actions by the Food and Drug Administration or the U.S. Patent and Trademark Office, and uncertainties regarding the status of biotechnology patents, 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.