Neurovax almost ready to start its next phase II trial.
The Immune Response Corporation Secures Key Partners for Launch of Phase II Trial of NeuroVax(TM) In Patients with Multiple Sclerosis
October 10, 2006 - PRNewswire-FirstCall - The Immune Response Corporation today announced that it has entered into an agreement with Accelsiors CRO & Consultancy Services, a clinical research organization (CRO) with extensive experience in conducting multiple sclerosis (MS) trials, to oversee the 200-patient Phase II trial of NeuroVax, an investigational T-cell receptor (TCR) peptide vaccine for the treatment of MS.
The Company further announced that this November in Budapest, Hungary, it will hold a clinical trial launch meeting with investigators participating in the trial and expects patient enrollment of the multi-center, randomized, double-blind trial to begin shortly thereafter. NeuroVax may represent a significant advance in the treatment of MS, which affects more than 2.5 million people worldwide, including more than 400,000 in the United States.
"We are extremely excited at the potential of NeuroVax to help patients with Multiple Sclerosis," said Krzysztof Selmaj, MD, PhD, Dept. of Neurology, Medical University of Lodz, Poland, Coordinating Investigator of the study. "This treatment may have the ability to alter how the immune system fights MS and we eagerly anticipate study results that could offer benefit to the millions of MS patients in need of more effective and tolerable treatment options."
The trial will enroll 200 patients with relapsing-remitting MS and will examine the effectiveness and safety of NeuroVax versus placebo. The primary objective of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
The Company has also contracted with NeuroRx Research, a company with special expertise in advanced MRI acquisition and analysis techniques, to oversee professional management of all MRI-related study activities.
"This trial is truly a watershed event for the Company, and potentially for the MS community as well," said Dr. Joseph O'Neill, President and CEO of The Immune Response Corporation. "We've made tremendous strides in building on the early NIH-funded research into NeuroVax and have now taken the critical steps necessary to launch a robust trial in multiple countries."
NeuroVax, which is based on IRC's patented TCR peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. A recently published study showed that NeuroVax induced strong disease- specific cellular immunity in essentially all patients who received it. In addition, results from a one-year Phase I/II study, presented at this year's American Academy of Neurology annual meeting, showed that NeuroVax was able to restore normal levels of FOXP3+ Treg cells in patients who had statistically significant diminished levels compared to healthy controls (p<0.02). These Treg or regulatory T-cells appear to help control levels of pathogenic T-cells in MS patients.
MS is an autoimmune disease in which the immune system mistakenly attacks normal tissues of the central nervous system. The disease is caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack a fatty tissue called myelin that surrounds and protects nerve fibers and creates multiple areas of scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This damage, in turn, leads to a variety of chronic, highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment.
By restoring healthy regulatory T-cell function, NeuroVax may offer a new and highly targeted mechanism to control pathogenic T-cell activity and limit or prevent nerve tissue damage in MS patients. Moreover, with a once a month dosing regimen and side effects that are so far limited to transient injection site reactions, NeuroVax could prove to be very easy for patients to tolerate compared to existing MS therapies.
About the Study
This trial is a multi-center, randomized, double-blind, placebo-controlled 48-week study to assess the safety and efficacy of NeuroVax. Two hundred subjects with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS) score of less than or equal to 5.5 and meeting all inclusion/exclusion criteria, will be enrolled in the study in several Central and Eastern European countries including Belarus, Bulgaria, Poland, Russia, Serbia and Montenegro, Slovakia, and Ukraine. Clinical sites in these European countries have demonstrated themselves to be favorable locations for conducting efficient Phase II placebo-controlled MS studies by providing experienced clinical investigators, large patient populations and excellent MRI facilities.
Study participants will be randomized equally to receive either NeuroVax (100 microliters/mL of each of three T cell receptor peptides) or placebo (Incomplete Freund's Adjuvant) intramuscularly in the deltoid muscle every four weeks. Evaluation will occur every eight weeks by brain MRI scan and patients will also undergo evaluation by neurology examinations at 12, 24, 36, and 48 weeks. Safety will be monitored by routine physical exams that will be performed at 24 and 48 weeks, and lab tests of hematology, chemistry panel and urinalysis will be performed at weeks 4, 12, 24, 36, and 48.