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April 4, 2000-- Company to Plan New Phase II Clinical Trial To Establish
Definitive Efficacy in Relapsing Remitting Patients
Nuerocrine Biosciences Inc. (Nasdaq:NBIX - news) Tuesday announced clinical results from a Phase II clinical trial in patients with relapsing remitting multiple sclerosis.
Although dosing was suspended in July 1999, following several reported cases of hypersensitivity, patients were followed for the full treatment period, pursuant to the clinical protocol.
The results indicate NBI 5788 demonstrated clinical benefit in patients in the low dose group. Fifty percent of patients in the 5mg. dose group experienced a reduction in new lesions as well as a reduction in total lesion load and volume as compared with 25% in the placebo group. Due to the early suspension of dosing, the number of patients receiving the full treatment was too small to show statistical significance between the treatment groups and placebo.
In addition, the drug was safe and well tolerated at all dosage levels as compared with placebo. For those patients experiencing hypersensitivity (less than 9% of the total enrolled patients), there was no exacerbation of disease. Based on these positive results, the company is planning a new Phase IIb trial to establish the definitive efficacy profile and optimum dosing regiment of NBI 5788. Future trials will be aimed at further establishing the benefit of altered peptide ligands (APL) therapy for patients with multiple sclerosis.
``The results of the Phase II trial are encouraging. Clinical data and magnetic resonance imaging indicated a trend towards improvement compared to placebo. In addition, the immune response was shifted towards suppressing autoimmunity in the brain, by deviating the immune response away from the pathologic Th1 response to the suppressive Th2 response,' said Dr. Lawrence Steinman, professor or Neurology and Neurological Sciences at Stanford University. ``The hypersensitivity responses seen were not linked to any nuerologic worsening, and appeared after high dose prolonged administration. This Phase II trial appears quite promising.'
The trial was initially designed and conducted in collaboration with Novartis. In July 1999, the Data Safety Monitoring Board assigned to the trial recommended that dosing in the trial be suspended based upon reported hypersensitivity reactions in a small percentage of patients in the trial. Novartis and Neurocrine continued the trial and completed the patient follow-up in December 1999. In January 2000, Neurocrine reacquired the rights to the product from Novartis and initiated data analysis which lead to these findings.
The study was a double blind, randomized, placebo-controlled multicenter study evaluating safety, tolerability and effect on MRI lesion parameters of three doses (5mg., 20mg., 50mg.) of NBI 5788 vs. placebo in patients with relapsing-remitting multiple sclerosis. The study consisted of three phases: baseline, double blind and extension phases. The baseline phase consisted of a one-month period in which two MRI scans were conducted, at the beginning and end. The double blind phase consisted of treatment with NBI 5788 at three dose levels vs. placebo. Monthly MRI scans were conducted during this phase.
Fifty-three patients completed the double blind phase of the study, 79 patients were ongoing at the time of dosing suspension. Among the patients who completed the double blind phase of the study, 50% of the patients in the low dose group (5mg.) experienced greater reductions in new enhancing lesions than did patients in the other high dose groups including placebo (20mg -- 18%; 50mg -- 11%; placebo -- 25%). Lesion volume and total load was also reduced in patients receiving the low dose.
``The trial shows promise. Further trials are warranted for this novel and potentially highly specific immune therapy of MS,' said Ludwig Kappos, professor of Neurology Kantonsspital, and professor at the University of Basel and principal investigator of the APL-MS clinical trial. |
