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May 23, 2011
Promedior reported results from a phase I trial of PRM-151 for idiopathic pulmonary fibrosis (IPF). This randomized double blind, placebo controlled study initially enrolled 26 healthy subjects who received single intravenous doses of PRM-151 from 0.1mg/kg to 20mg/kg. After completion of dosing of the healthy subjects, three subjects with IPF were administered a single dose of 10mg/kg intravenously. Single doses of PRM-151 up to 20mg/kg were safe and well tolerated in both populations. Analysis of efficacy biomarkers comparing the healthy versus IPF subjects showed a 50% reduction of CD45+/collagen-1+ fibrocytes within peripheral blood of all IPF subjects at 24 hours, and fibrocytes remained suppressed for up to 21 days in the majority of subjects. Analysis also indicated that elevated serum IL-6 levels observed at baseline in the IPF subjects decreased up to 50% (P<0.05) when measured 48 hours after PRM-151 dosing.
March 13, 2006
Amarillo Biosciences reported positive interim results of a clinical trial of their orally administered formulation of low-dose interferon alpha (IFNa), for the treatment of idiopathic pulmonary fibrosis (IPF), at the Southern Regional Meeting of the Society for Clinical Investigations in Atlanta. Results to date indicated that low dose IFNa was well tolerated, with no serious adverse events reported. The regimen was shown to stabilize IPF or produced minimally progressive disease in 10 of 12 subjects who received the drugs for at least 12 months; two subjects had experienced disease stabilization of over 24 and 48 months respectively. This ongoing open-label study has enrolled 20 subjects to date, who received 150 u IFNa via oral lozenge thrice daily. Based on these results, the company announced plans to submit a phase II protocol and an Orphan Drug application for the drug to the FDA.
December 5, 2005
Actelion reported negative results of their phase III BUILD-1 trial of Tracleer (bosentan) for the treatment of idiopathic pulmonary fibrosis (IPF). Trial data failed to demonstrate a significant improvement in distance walked in a 6 minute walk exercise test vs. placebo, the trial's primary endpoint. Secondary data were also non-significant, but did yield a positive trend in the combined incidence of death or treatment failure (worsening of pulmonary function tests or acute IPF decompensation) at 12 months (22.5% for bosentan, vs. 36.1% for placebo; p=0.076). This randomized, double-blind, placebo-controlled, multi-center study enrolled 158 patients, who were treated with the drug or placebo for 12 months. Based on these results, the company announced plans to investigate the drug's ability to reduce mortality in an additional trial.
May 9, 2005
InterMune and Shionogi have reported positive interim results of a phase II trial of pirfenidone, for the treatment of idiopathic pulmonary fibrosis. Positive results from the first 9 months were observed in the study's primary efficacy endpoint, with a trend towards improvement in change in lowest oxygen saturation during a 6-minute exercise test in the overall population (p=0.072), and a significant effect in the subset of patients with milder disease (p=0.0305). Significance in several secondary endpoints was also achieved, including change from baseline in vital capacity (p=0.0366), categorical assessment of the proportion of patients who improved, were stable, or declined (p=0.0028), and portion of patients experiencing acute symptom exacerbations requiring hospitalization (0%, vs. 14% for placebo; p=0.0031). One placebo patient died due to symptom exacerbation. The overall positive trend in data and the worsening of symptoms in the placebo group led the trial's independent Data Safety Monitoring Board (DSMB) to halt the trial early after this planned 9-month interim analysis. This randomized, double-blind, placebo-controlled study enrolled 107 subjects in Japan, and was originally scheduled to have a 12 month treatment period. Following these positive results, InterMune announced plans to meet with the FDA to discuss the design of upcoming phase III trials, which are expected in the first half of 2006.