XOMA corporation ( NASDAQ: XOMA ), stock of the company spiked more than 15 % suddenly, traders might keep an eye on stock as there might be a big news announcement from the company.
Company has announced an enrollment for Phase II/Phase III trials of gevokizumab to treat interleukin-1 beta-mediated inflammatory diseases
Press release read below
It has opened enrollment in two clinical trials to determine gevokizumab's potential to treat interleukin-1 beta-mediated inflammatory diseases. The first trial is XOMA's global Phase 3 study investigating the ability of gevokizumab to reduce the signs and symptoms, including vitreous haze, in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. The second trial is a Phase 2 study to evaluate the potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with erosive osteoarthritis of the hand. Patients currently are being screened in both trials.
In this study, titled A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis, the Company intends to enroll patients with active non-infectious intermediate, posterior, or pan-uveitis with a vitreous haze score equal to or greater than 2+ on the Standardization of Uveitis Nomenclature (SUN) / National Eye Institute (NEI) scale in at least one eye. They will be randomized to receive either one of two doses of gevokizumab or placebo. The study's primary endpoint is the proportion of patients demonstrating a significant reduction in vitreous haze score on Day 56. The study also will assess the effect of gevokizumab on additional endpoints, including response rates at other time points and changes from baseline in visual acuity.
Paul Rubin, M.D., XOMA's Senior Vice President of Research and Development and Chief Medical Officer, stated, "As preclinical and clinical data have shown that IL-1 beta is an important contributor to the inflammation seen in uveitis, we believe gevokizumab's ability to potently inhibit IL-1 beta signaling could be relevant in controlling this inflammation, as well as the inflammation associated with other conditions. Because of this, we established a proof-of-concept program in November 2011 to lead us to additional indications for this antibody. Included in this program is the ongoing trial in moderate to severe acne vulgaris from which we anticipate top-line data by year end. Today, we opened enrollment in the second POC indication, erosive osteoarthritis of the hand, which we believe will complete enrollment sometime around the end of 2012."
XOMA's Phase 2 proof-of-concept study of gevokizumab in active inflammatory, erosive osteoarthritis of the hand is designed to enroll approximately 90 patients who will be randomized to receive gevokizumab or placebo. The study is designed and powered to detect a significant improvement from baseline versus placebo in the mean Australian/Canadian Hand Osteoarthritis Index (AUSCAN™) pain score in the target hand at three months. The study also will capture multiple outcome measures including pain, stiffness, physical function, radiographic and MRI changes, as well as changes in C-reactive protein and concomitant acetaminophen use.
About XOMA corporation:
XOMA Corporation (XOMA), formerly XOMA Ltd., discovers and develops antibody-based therapeutics. XOMA’s drug candidate gevokizumab is an antibody that binds to the inflammatory cytokine interleukin-1 beta (IL-1 beta). Its XOMA 3AB is a biodefense anti-botulism product candidate consists of a combination of antibodies, was developed through funding from the National Institute of Allergy and Infectious Diseases (NIAID) of the United Sates National Institutes of Health (NIH). In June 2011, it discovery of two classes of human monoclonal antibodies, XOMA Metabolic Activating and Sensitizing (XMetA and XMetS), On January 17, 2012, it announced that it had acquired the United Sates rights to the perindopril franchise from Servier. The agreement includes ACEON, a marketed angiotensin converting enzyme (ACE) inhibitor, and a portfolio of three fixed-dose combination product candidates where perindopril is combined with another active ingredient(s), such as a calcium channel blocker.
Company has announced an enrollment for Phase II/Phase III trials of gevokizumab to treat interleukin-1 beta-mediated inflammatory diseases
Press release read below
It has opened enrollment in two clinical trials to determine gevokizumab's potential to treat interleukin-1 beta-mediated inflammatory diseases. The first trial is XOMA's global Phase 3 study investigating the ability of gevokizumab to reduce the signs and symptoms, including vitreous haze, in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. The second trial is a Phase 2 study to evaluate the potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with erosive osteoarthritis of the hand. Patients currently are being screened in both trials.
In this study, titled A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis, the Company intends to enroll patients with active non-infectious intermediate, posterior, or pan-uveitis with a vitreous haze score equal to or greater than 2+ on the Standardization of Uveitis Nomenclature (SUN) / National Eye Institute (NEI) scale in at least one eye. They will be randomized to receive either one of two doses of gevokizumab or placebo. The study's primary endpoint is the proportion of patients demonstrating a significant reduction in vitreous haze score on Day 56. The study also will assess the effect of gevokizumab on additional endpoints, including response rates at other time points and changes from baseline in visual acuity.
Paul Rubin, M.D., XOMA's Senior Vice President of Research and Development and Chief Medical Officer, stated, "As preclinical and clinical data have shown that IL-1 beta is an important contributor to the inflammation seen in uveitis, we believe gevokizumab's ability to potently inhibit IL-1 beta signaling could be relevant in controlling this inflammation, as well as the inflammation associated with other conditions. Because of this, we established a proof-of-concept program in November 2011 to lead us to additional indications for this antibody. Included in this program is the ongoing trial in moderate to severe acne vulgaris from which we anticipate top-line data by year end. Today, we opened enrollment in the second POC indication, erosive osteoarthritis of the hand, which we believe will complete enrollment sometime around the end of 2012."
XOMA's Phase 2 proof-of-concept study of gevokizumab in active inflammatory, erosive osteoarthritis of the hand is designed to enroll approximately 90 patients who will be randomized to receive gevokizumab or placebo. The study is designed and powered to detect a significant improvement from baseline versus placebo in the mean Australian/Canadian Hand Osteoarthritis Index (AUSCAN™) pain score in the target hand at three months. The study also will capture multiple outcome measures including pain, stiffness, physical function, radiographic and MRI changes, as well as changes in C-reactive protein and concomitant acetaminophen use.
About XOMA corporation:
XOMA Corporation (XOMA), formerly XOMA Ltd., discovers and develops antibody-based therapeutics. XOMA’s drug candidate gevokizumab is an antibody that binds to the inflammatory cytokine interleukin-1 beta (IL-1 beta). Its XOMA 3AB is a biodefense anti-botulism product candidate consists of a combination of antibodies, was developed through funding from the National Institute of Allergy and Infectious Diseases (NIAID) of the United Sates National Institutes of Health (NIH). In June 2011, it discovery of two classes of human monoclonal antibodies, XOMA Metabolic Activating and Sensitizing (XMetA and XMetS), On January 17, 2012, it announced that it had acquired the United Sates rights to the perindopril franchise from Servier. The agreement includes ACEON, a marketed angiotensin converting enzyme (ACE) inhibitor, and a portfolio of three fixed-dose combination product candidates where perindopril is combined with another active ingredient(s), such as a calcium channel blocker.
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