Erosive Osteoarthritis of the Hand Phase 2 POC Study
The Phase 2 POC study in erosive osteoarthritis of the hand ("EOA") patients with elevated C-reactive protein ("CRP") levels greater than or equal to 2.5 mg/L is a double-blind, placebo-controlled study to determine if gevokizumab can improve the pain, stiffness, and physical function associated with EOA after three and six months of treatment, based upon the Australian/Canadian Osteoarthritis Hand Index ("AUSCAN™") scoring scale. AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions.
In this study, the percent change in AUSCAN score is measured from baseline on a monthly basis, with efficacy assessments calculated at Day 84 and Day 168. The Day 84 results demonstrate gevokizumab-treated patients experienced a greater lowering in their mean AUSCAN score than patients in the placebo-treated group. After three months of treatment, patients who received gevokizumab (n=57) demonstrated a 23 percent reduction from baseline in the composite AUSCAN score compared to a 14 percent reduction in placebo arm patients (n=28). In addition to AUSCAN score, Day 84 and Day 168 endpoints also include radiographic images to assess the potential change in joint damage from baseline.
The study will continue on a blinded basis until all patients receive the full six months of treatment. Upon completion of the study, including the analysis of radiographic images of the affected joints, and the conclusion of the supplemental study in patients with CRP less than 2.5 mg/L, both of which are expected to occur in the first quarter of 2014,
"Data from this trial has allowed us to determine that a pivotal study would require around 230 patients in each arm in order to achieve statistical significance at the same magnitude of effect we saw at three months. If the improvement in response trends we have observed continue, the six-month endpoint, which is the accepted primary endpoint for studies in arthritis, should require even fewer subjects per arm," said
Pyoderma Gangrenosum Pilot Study
"Pyoderma gangrenosum is a serious, highly debilitating, very rare disease with limited therapeutic options and high unmet need. We initiated our POC trial based on discussions with
Gevokizumab was generally well tolerated, and there were no drug-related serious adverse events reported in the studies. In the EOA study, the most common adverse events were headache, pain, urinary tract infections and pneumonia and they were comparable between gevokizumab and placebo. In the open-label studies, patients reported mild to moderate headache, nausea, diarrhea, chest congestion, and secondary skin infections, all of which resolved with treatment and one case of unrelated ongoing exfoliative dermatitis following antibiotic treatment.
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Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in diverse array of disease states, including non-infectious uveitis (including Behçet's uveitis), cardiovascular disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3 clinical program, termed EYEGUARD™, which is being conducted by
About Erosive Osteoarthritis of the Hand
Erosive osteoarthritis of the hand (EOA) is caused by the breakdown of the body's natural balance between cartilage formation and degradation, which leads to the narrowing of the space between the first and second joints in the fingers. Patients with EOA experience high degrees of pain, including throbbing, swelling, and prolonged periods of morning stiffness. Over time, the joints become deformed, impacting hand function and ultimately reducing EOA patients' quality of life. Approximately four million people in the U.S. have been diagnosed with EOA, and the disease affects women twelve times more often than men for reasons that are not understood by the scientific or medical community.
About Neutrophilic Dermatoses
Neutrophilic dermatoses are a group of conditions that are characterized by skin lesions that have intense epidermal and/or dermal inflammatory infiltrates, primarily neutrophils, with no evidence of infection. They are classified based upon their individual clinical and pathologic features, as well as the identification of underlying diseases that are associated with neutrophilic dermatoses. Neutrophilic dermatoses can present as vesiculopustules (blisters), plaques (superficial, solid, elevated skin lesions), nodules (a small mass of tissue that protrudes or a knot that can be felt), or ulcers, and the lesions may be localized or cover a large area of the body. The causes of neutrophilic dermatoses are unknown, but patients may be experiencing an immunologic reaction. Most neutrophilic dermatoses are treated with systemic corticosteroids and other immunomodulators.
About Pyoderma Gangrenosum
Pyoderma gangrenosum ("PG") is a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers, which has four classifications based upon the type of skin ulcers manifested. Both the
About Generalized Pustular Psoriasis
Generalized pustular psoriasis ("GPP") is a rare acute, chronic, or relapsing neutrophilic dermatosis. Chronic and relapsing disease typically are characterized by episodes of fever and tremors, which are accompanied by the immediate appearance on the skin of non-infectious pustules that merge to become larger clusters of pus, dry, and peel off in sheets. These episodes may take weeks to resolve, and after an episode, the patient may be left with significant scaling of the affected areas. Patients who experience GPP may have localized disease, or the disease may affect the majority of their bodies, and one form, named
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Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials and proof-of-concept trials, anticipated size of clinical trials, continued sales of approved products, sufficiency of our cash resources and anticipated levels of cash utilization, 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, and 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. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
XOMA Corporation Companyand Investor Contact: Ashleigh Barreto510-204-7482 firstname.lastname@example.org Juliane Snowden The Oratorium Group, LLCjsnowden@oratoriumgroup.com Media Contact: Canale Communications Carolyn Hawley619-849-5375 email@example.com
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