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Asthma

September 8, 2014

Teva Pharmaceutical Industries reported positive results in two phase III trials of reslizumab for clinical asthma exacerbations (CAE) compared to placebo in patients with inadequately controlled, moderate to severe asthma with elevated levels of blood eosinophils. The two pivotal phase III studies involved 953 patients across 232 medical centers worldwide, including the U.S., E.U. and the Far East. These new data are from two global, phase III, 12-month, randomized, double-blind, placebo-controlled, parallel- group studies evaluating the efficacy and safety of intravenously administered reslizumab (3mg/kg) once every four weeks, compared to placebo in asthma patients (ages 12-75 with elevated blood eosinophils) inadequately controlled by standard of care therapy. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo (50% and 60% respectively, p<0.0001 for both). This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs (>5%) was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. The ongoing development of a subcutaneous formulation is expected to be submitted for approval in the second half of 2017.

December 16, 2013

GlaxoSmithKline and Theravance issued results of a phase III trial of fluticasone furoate “FF”/vilanterol “VI” for the treatment of adult asthma. The study was a 12-week, randomized, double-blind, parallel-group, multicenter study to assess the efficacy and safety of FF/VI200/25mcg inhalation powder, FF/VI100/25mcg inhalation powder and FF100mcg inhalation powder, evaluating 990 patients with moderate to severe persistent asthma. The primary endpoint was weighted mean serial forced expiratory volume in one second (FEV1) at the end of the 12-week treatment period. The primary comparison was FF/VI100/25mcg versus FF 100mcg. For the pre-specified primary endpoint of 0-24-hour weighted mean FEV1, FF/VI 100/25mcg demonstrated a statistically significant improvement in lung function compared with FF 100mcg (108ml, 95% CI 45, 171 p<0.001) at the end of the 12-week treatment period. In patients receiving FF/VI 200/25mcg, an additional improvement of 24ml (95% CI -37, 86) was observed when compared with FF/VI 100/25mcg. These results will inform GSK’s discussions with the FDA on the regulatory requirements of an asthma indication for FF/VI in the U.S.

April 2, 2012

Biota Holdings issued results from a phase II trial of vapendavir for the treatment of naturally acquired human rhinovirus (HRV) infection in asthmatics. This multicenter, randomized, double-blind, placebo controlled study enrolled 300 subjects who received either 400 mg of vapendavir or placebo twice daily for six days. The trial was conducted over two consecutive rhinovirus seasons. The primary efficacy parameter was the mean daily difference in WURSS-21 (Wisconsin Upper Respiratory Symptom Survey-21) severity score over days two through four. Vapendavir treatment resulted in a statistically significant reduction in the severity score of cold symptoms when compared to placebo (p≡0.028). The WURSS scores also showed a statistically significant improvement in mean daily difference through day 14 (p≡0.001). Reduction in the use of asthma reliever medication showed a positive trend toward improvement in the vapendavir group as early as day three of treatment and reached statistical significance on day 13 (p≡0.045). In addition, subjects receiving vapendavir showed a statistically significant lower incidence of virus infection (74.4%) compared to placebo (91.4%) on day three (p≡0.025) and evening peak expiratory flow (PEF) was significantly higher in the vapendavir group on day five (p≡0.023). There were no serious adverse events and generally BTA798 was well tolerated.

August 29, 2011

Verona Pharmaceuticals issued results from a phase II trial of RPL554 for the treatment of mild asthma. This blind, randomized, placebo-controlled trial enrolled 12 subjects who received daily doses of RPL554 for six days. Efficacy on lung function was based on the standard measure of FEV1 (Forced Expiratory Volume in 1 sec). RPL554 successfully sustained bronchodilator actions throughout the treatment period. Identical bronchodilator responses were seen after one, three and six days of treatment. There was no evidence of RPL554 accumulation in plasma over the six days. There were no safety concerns, although there was a minor increase in heart rate at day six.

March 1, 2010

Ception reported positive results from a phase II study of Cinquil for the treatment of eosinophilic asthma. This four-month, double-blind, placebo-controlled study enrolled 106 adults with poorly controlled eosinophilic asthma. The subjects received Cinquil (3mg/kg) or placebo administered intravenously once every 28 days for four cycles. The primary study endpoint was improvement in asthma control as assessed by the change in Asthma-Control-Questionnaire (ACQ) score at week 15. Subjects who received Cinquil showed an improvement on the ACQ compared to placebo (p≡0.054). Secondary endpoints were reached as well, including a significant reduction in sputum eosinophil counts for Cinquil compared to placebo (p≡0.006) and a significant improvement in FEV1 (Forced expiratory volume in one second) and FVC (forced volume vital capacity) for Cinquil compared to placebo (p≡0.002 and 0.004 respectively). In addition, in a subset of subjects with both asthma and nasal polyps (n≡38), Cinquil resulted in a significant mean improvement in ACQ (p&eequiv;0.011) and FEV1 (p≡0.046) versus placebo.

May 11, 2009

Almirall reported results from a phase IIa trial of LAS-100977 for the treatment of asthma. This single dose, randomized, four-period cross-over efficacy and safety study enrolled 28 subjects with mild-moderate persistent asthma. All subjects were on stable doses of an inhaled corticosteroid. They were instructed to inhale once, one of three doses of LAS100977 or placebo in each treatment period, using a dry powder uni-dose capsule inhaler. The primary endpoint was change from pre-dose in trough forced expiratory volume in one second (FEV1- mean FEV1 between 23 and 24 hours post-dose). Results showed a statistically and clinically significant increase in change from pre-dose trough FEV1 versus placebo for all doses of LAS100977, as well as a sustained and significant effect over a 24 hour period. In addition, LAS100977 provided a quick onset of action five minutes after the first administration. All doses tested were very well tolerated.

December 8, 2008

GSK and Theravance reported positive results from a phase IIb trial of GW642444 for the treatment of asthma. This double-blind, placebo controlled study enrolled 604 subjects with moderate to severe asthma who were receiving an inhaled corticosteroid. The subjects received one of five doses of GW642444, (3, 6.25, 12.5, 25 and 50 mcg) or placebo, administered once daily via an inhaler. The primary endpoint was change in trough (23-24 hour) forced expiratory volume in 1 second (FEV1) from baseline after 28 days. This endpoint was reached with statistical significance at all but the two lowest doses of GW642444 (p<0.05). Efficacy was also observed in a number of secondary endpoints, including improvements in peak expiratory flow both in the morning and evening, and the percentage of symptom-free days and rescue-free days. Use of rescue medication was significantly lower in subjects receiving the three highest doses of GW642444 compared to those on placebo. Onset of action was dose-dependent and the bronchodilator effect was sustained over 24 hours. In addition, improvements in lung function 24 hours after the first dose were maintained throughout the 28 day treatment period.

September 15, 2008

MediciNova reported positive preliminary results from a phase II trial of MN-221 for the treatment of asthma. This randomized, open-label, placebo-controlled study enrolled 17 subjects with moderate to severe asthma, in the U.S. The subjects were placed into two cohorts and received either MN-221 (1,125 micrograms) or placebo over one hour by a continuous intravenous infusion or MN-221 (1,080 micrograms) or placebo over two hours by a continuous intravenous infusion. Both cohorts demonstrated clinically significant improvements in forced expiratory volume in one second (FEV1). At the end of the one-hour infusion, FEV1 increased by 17.5% for MN-221 compared to an increase of 3% for placebo. At the end of the two-hour infusion, FEV1 increased by an average of 12.1% for MN-221 compared to an increase of 1.4% for placebo. MN-221 was well tolerated across both infusion groups. Based on the results, MediciNova is planning to move forward with phase IIb trials.

July 28, 2008

SkyePharma reported positive results from a phase III trial of Flutiform for the treatment of asthma. This randomized, double-blind, placebo- controlled, parallel group, stratified, multi-center study, dubbed SKY2028-3-001, enrolled 475 subjects with mild to moderate asthma in North America and Europe. The subjects received Flutiform (100/10 micrograms twice daily) in a single inhaler, fluticasone (100 micrograms twice daily), formoterol (10 micrograms twice daily) or placebo for 12 weeks. The primary endpoint, improvement in FEV1 (forced expiratory volume in the first second), was reached with statistical significance over fluticasone and formoterol taken alone and placebo. In addition, there were a significantly lower number of discontinuations due to lack of efficacy for Flutiform compared with placebo. Based on positive phase III results, SkyePharma plans to file an NDA with the FDA in Q1, 2009.

April 14, 2008

MAP Pharmaceuticals released positive results from a phase IIa trial of MAP-0005 for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This randomized, open-label, active-controlled, crossover, safety and dose response study enrolled fifteen adult subjects. The subjects received two different emitted doses of MAP0005, 104/5.4 mcg and 312/16.2 mcg, or a 160/9 mcg dose of the leading currently approved product. Maximum change in forced expiratory volume in one second (FEV1) was similar for all three treatments, as was time to maximum change in FEV1. Plasma levels of budesonide were dose proportional for MAP0005. No serious or unexpected adverse events were reported in the study, and MAP0005 was well tolerated. Based on the results, MAP plans to move forward with the development of MAP-005.

March 31, 2008

MAP Pharma released positive results from a pharmacokinetic trial of Unit Dose Budesonide (UDB) for the treatment of asthma. This randomized, open label, cross-over study enrolled thirty two adult subjects with mild to moderate asthma. A 0.135 mg dose of UDB was compared to a 0.25 mg dose of conventional nebulized budesonide given twice daily, and a 0.25 mg dose of UDB was compared to a 0.5 mg dose of conventional nebulized budesonide given twice daily. Data showed that compared to conventional nebulized budesonide, UDB demonstrated faster times to maximum blood concentrations and had similar maximum blood concentrations. In addition, the nebulization time for UDB in this population was shorter than for the conventional nebulized budesonide product. Treatment was well tolerated, with serious adverse events reported. A phase III trial of Unit Dose Budesonide is currently underway.

October 15, 2007

MediciNova released positive results from a phase IIa trial of MN-221 for the treatment of status asthmaticus. This randomized, double-blind, placebo controlled, dose-escalation trial enrolled 23 subjects in the US. At each dose level in the escalation, subjects received either a 15-minute intravenous infusion of MN-221, at doses of 3.5, 10, 16, 30 and 60 micrograms/min, or placebo. Statistical significance was reached in the primary endpoint, mean change in FEV1 (forced expiratory volume in 1 second) from baseline versus placebo, for all doses except the lowest dose (p less than or equal to 0.0006). MN-221 also produced a significant linear, dose-related increase in mean change in post-infusion FEV1 from baseline (p less than or equal to 0.0001) after 15 minutes. Significant improvements in mean change in post-infusion FEV1 from baseline were observed at doses of 10, 16, 30 and 60 micrograms/min (p less than or equal to 0.0006) and at the dose of 3.5 micrograms/min (p=0.0106), compared to placebo. Treatment was generally well tolerated. Based on the results MediciNova plans to initiate a second phase IIa trial shortly.

April 9, 2007

GlaxoSmithKline and Theravance issuedpositive results from a phase IIb trial of GSK159797 for the treatment ofasthma. This randomized, crossover, double-blind, placebo- andactive-controlled trial enrolled 55 subjects with asthma who were controlled oninhaled corticosteroids. Subjects received 10, 15 and 20 mcg of GSK159797 oncedaily, or salmeterol given twice daily, for 14 days. The primary endpoint wasimprovement in forced expiry volume in one second (FEV1) over baselinecorticosteroid therapy with GSK159797 versus salmeterol. All doses of GSK159797showed comparable bronchodilator activity when compared to salmeterol. Inaddition, treatment showed a similar pharmacokinetic profile to other relatedinhaled long-acting Beta2 agonist's (LABAs), with little effect on heart rate.Based on the results the companies plan to move the development of this therapyforward.

August 28, 2006

Critical Therapeutics announced positive results from a phase I/II trial of zileuton i.v for the treatment of asthma. This double-blind, placebo-controlled trial took place at 10 sites across the United States and enrolled 60 subjects, all of whom had a mean FEV(1) (forced expiratory volume in one second) of 63% of predicted normal at baseline. Subjects were randomized into one of four escalating dose groups, 75 mg, 150 mg, 300 mg, and 600 mg. Each group included 15 subjects, 12 who received one infusion of zileuton i.v and 3 who received one infusion of placebo. Zileuton was well tolerated at all doses, with no serious adverse events reported. Treatment proved to be efficacious as well. FEV(1) levels were measured at 10, 30 and 60 minutes and revealed a greater mean percentage improvement in all four treatment cohorts when compared to placebo. Additional data, including pharmacokinetic profiles, are scheduled for release in September of 2006.

July 24, 2006

Topigen reported positive preliminary results from a phase II trial of TPI-ASM8 for the treatment of asthma. This randomized, placebo-controlled, multicenter, crossover, allergen-challenge proof-of-concept study had enrolled 17 subjects to date, who received once-daily doses of the drug for four days, at doses similar to those for approved steroids. Preliminary results indicated that the drug was generally safe and well tolerated. Biological and physiological activity was also noted, including reductions of eosinophil cell levels and suppression of target gene expression. Based on these results, the company announced plans to conduct expanded phase II trials of the drug.

July 10, 2006

deCODE genetics and Cephalon have announced positive results from a phase IIa trial of CEP-1347 for the treatment of asthma. Preliminary efficacy data yielded evidence of dose dependent improvements in several parameters of lung function, including methacholine challenge test and peak expiratory flow rates, as well as in a biomarker associated with asthma severity and inflammation. Safety and tolerability data yielded no serious concerns. This randomized, double-blind, placebo-controlled study enrolled 160 subjects, who received one of three doses of CEP-1347 or placebo.

April 24, 2006

CombinatoRx issued mixed results of a phase II trial of CRx-170, which combines low dose regimens of the approved drugs budesonide and nortriptyline, for the treatment of asthma. Data did not meet the trial's primary endpoint, producing no significant change in levels of the inflammatory biomarker CD163. The drug did demonstrate efficacy in a number of secondary endpoints, including increasing FEV1 (a measure of lung function and capacity) by 6% from baseline (p=0.045). Neither low dose budesonide (-5%, p=0.251) nor nortriptyline (-2%, p=0.466) produced an improvement when administered as a single agent. Further, CRx-170 reduced Late Allergen Response area by more than 50% from baseline (p=0.053). This single-blind, dose de-escalation proof-of-concept study enrolled 19 patients at a single site, who receives descending oral doses of nortriptyline and budesonide, with washouts between treatments, followed by 1-week treatment with nortriptyline and 1-week with CRx-170.

January 30, 2006

LAB International has issued positive results of a phase I trial of LAB CGRP (calcitonin gene related peptide), for the treatment of asthma. Results of the study were positive, with no clinically significant changes in safety measures, including laboratory values, heart rate, blood pressure or ECG at any trial dose. The drug was shown to dose-dependently increase circulating CGRP levels at the 1 mg and 5 mg dose. The lower two trial doses did not significantly increase peptide levels. Additional pharmacokinetic values showed rapid absorption (31 to 125 pg/ml peak concentration range). This randomized, double blind, placebo-controlled dose escalating study enrolled 10 healthy volunteers, who received one of four single inhaled doses of the drug (0.025 mg, 0.1 mg, 1.0 mg or 5.0 mg) or placebo.

July 11, 2005

Cambridge Antibody Technology has reported positive results of a phase I trial of CAT-354, their monoclonal antibody for the treatment of asthma. Trial data met primary safety and pharmacokinetic endpoints, with no serious adverse events reported, a positive overall adverse event profile, and an absorption and elimination profile in line with expectations from preclinical models. This double-blind, placebo-controlled single-escalating-dose study enrolled 34 patients with mild asthma. The company announced plans to initiate their second trial of the drug, a multiple-dose allergen-challenge clinical pharmacology study, in Q4 2005.

July 4, 2005

Cambridge Antibody Technology has reported positive results of a phase I trial of CAT-354, their monoclonal antibody for the treatment of asthma. Trial data met primary safety and pharmacokinetic endpoints, with no serious adverse events reported, a positive overall adverse event profile, and an absorption and elimination profile in line with expectations from preclinical models. This double-blind, placebo-controlled single-escalating-dose study enrolled 34 patients with mild asthma. The company announced plans to initiate their second trial of the drug, a multiple-dose allergen-challenge clinical pharmacology study, in Q4 2005.

May 30, 2005

Novartis announced positive results of a pair of phase II trial of their investigational bronchodilator indacaterol (QAB149), for the treatment of asthma and chronic obstructive pulmonary disease (COPD), at the Centenary Meeting of the American Thoracic Society. Results form the first study indicated that the drug produced effective dose-dependent 24-hour bronchodilation within 5 minutes of administration, and had a safety and tolerability profile comparable to placebo. The second study indicated a positive cardiovascular safety profile, with no observed impact on ECG readings, mean QTc interval, vital signs, of laboratory results. Both studies were randomized, double-blind, placebo-controlled trials. The first was a dose-ranging study which enrolled 42 patients with intermittent or mild to moderate persistent asthma, who received one of four doses of the drug (50 mcg, 100 mcg, 200 mcg, or 400 mcg) or placebo once daily. The second was a multi-center parallel- group safety and tolerability study which enrolled 156 subjects.

Sanofi-Aventis announced positive results of a phase III trial of their inhaled corticosteroid Alveso (ciclesonide) for the treatment of asthma at the 101st International Conference of the American Thoracic Society. Results from the study demonstrated that administration of the drug allowed a significant portion of subjects in both the low dose (29.8%; p=0.0386) and high dose (31.3%; p=0.233) Alvesco treatment groups were able to completely discontinue oral corticosteroids, vs. 11.1% for placebo. Secondary evaluations indicated that both doses of Alvesco produced significant reductions in mean overall oral corticosteroid dose (-47.39%, p= 0.0003; -62.54%, p=0.0001), and overall daily oral dose (-5.97 mg/day, p=0.0008; -8.00 mg/day, p= 0.0001). This multinational, multicenter, randomized, double-blind, placebo-controlled study enrolled 141 adult asthma patients currently taking oral corticosteroids, who received one of two doses of Alvesco (320 mcg or 640 mcg) or placebo twice daily for 12 weeks.

March 21, 2005

NicOX announced positive results of a phase IIa trial of NCX 1020, a nitric oxide donating derivative of the approved inhaled corticosteroid budesonide, for the treatment of asthma. Data yielded a trend towards efficacy in the primary endpoint, with a reduced incidence of bronchoconstriction at 4 hours following methacholine challenge (an effect not observed with the approved drug). Pharmacokinetic data demonstrated reduced peak plasma concentrations and delayed peak systemic absorption rates of budesonide versus an approved budesonide formulation, which the company hopes will lead to fewer systemic side effects. This double blind, 3-way cross over trial enrolled 12 asthmatic patients at the Department of Asthma, Allergy and Respiratory Science of King's College London, who were randomized in days 1, 4, and 7 to receive a single-dose of either NCX 1020 (600 mcg), budesonide (400 mcg) and placebo.

Targeted Genetics has issued the results of a phase II study of tgAAVCF, for the treatment of cystic fibrosis. Results from the study indicated that the drug failed to meet its primary endpoint, with no significant improvement in forced expiratory volume in 1 second (FEV1), a measure of lung function, following 30 days of treatment, vs. placebo. This double-blind, randomized, placebo-controlled study enrolled a total of 102 patients, who were randomized to receive two doses of either 1x1013 DNAse resistant particles of tgAAVCF (n=51) or placebo (n=51) via nebulizer at day 0 and day 30, and were evaluated for FEV1 every 2 weeks for 90 days. Analysis of data regarding secondary safety and efficacy endpoints, including FEV1 at 60 and 90 days, are ongoing, and the company hopes to announce complete safety and efficacy results for this trial later this year.

November 29, 2004

APT Pharmaceuticals has announced positive results of a phase I study of an aerosolized formulation of hydroxychloroquine, an approved anti-malarial and anti-rheumatic agent under investigation by APT for the treatment of asthma and inflammatory respiratory disorders. Trial data indicated that the drug met its primary endpoints, with no reported serious adverse events, an acceptable tolerability profile (including manageable taste disturbance), and a pharmacokinetic profile indicating systemic absorption well below clinically relevant doses used to treat rheumatic indications, potentially allowing higher localized doses with reduced systemic toxicity. This open-label safety, tolerability and pharmacokinetic trial enrolled healthy volunteers in Australia. APT announced that, based upon these results, they were seeking co-development or venture investors to fund phase II investigations.

August 2, 2004

Dynavax has announced positive results of a phase IIa asthma challenge study of ISS (inhaled immunostimulatory sequences). Results confirmed prior safety results, with no differences in any drug related adverse events between the highest dose if ISS and placebo, and demonstrated pharmacological activity, with significant increases in the expression of genes targeted by ISS. The data did not indicate evidence of changes in lung function between ISS subjects and placebo at two or four weeks. The placebo controlled study enrolled a total of 39 mild-to-moderate asthma suffers, who received weekly inhaled treatments and bi-weekly allergen challenge lung function tests. Dynavax has announced plans to begin efficacy trials in the near future.

June 28, 2004

Inflazyme reported negative results from their phase IIa study of IPL512,602, a leukocyte selective anti-inflammatory for the treatment of mild-to-moderate asthma. Results indicated that subjects treated with the drug achieved only a non-significant 2% improvement over placebo in Forced Expiratory Volume in 1 second (FEV-1), the study’s primary endpoint. The study randomized a total of 169 subjects in a double blind fashion to receive either 20 mg/day IPL512,602 or placebo for three months. Data did indicate some improvement in secondary endpoints (including peak expiratory flow and rescue inhaler use), and the drug was safe and well tolerated, but Inflazyme considered these benefits insufficient to support further development.

March 22, 2004

Protein Design Labs reported positive results from a phase II trial investigating daclizumab, a humanized antibody for the treatment of asthma. Results showed that the trial reached statistical significance in the percent of change in pulmonary function (FEV1) from baseline, the studies primary endpoint. Subjects receiving daclizumab demonstrated a mean increase in FEV1 of 4.4% from baseline, compared with 1.5% with placebo. The randomized, double-blind, placebo-controlled study enrolled 114 subjects with chronic asthma at 24 sites in the U.S. Subjects in the treatment group received an initial dose of daclizumab (2 mg/kg) intravenously, followed by subsequent doses of 1 mg/kg. Results will be reported at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Francisco.

February 2, 2004

Sepracor and Henry Ford Health Systems reported positive results from a phase IV trial investigating Xopenex (levalbuterol), a beta-adrenergic receptor agonist for the treatment of asthma. Results showed that treatment with Xopenex in the emergency room can significantly improve lung function and clinical outcomes for acute asthma attacks. Data showed subjects given Xopenex had more rapid airway improvement and spent less time in emergency than those treated with conventional care. In the study subgroup, Xopenex (1.25 mg) acieved a 75% change in baseline forced expiratory volume in one second (FEV1). The prospective, open label, non-randomized, pilot study enrolled 91 subjects in theHenry Ford Hospital, Detroit, and the Cleveland Clinic and the MetroHealth Center, Cleveland.

January 19, 2004

Neurogen reported negative results from a phase IIa trial investigating NGD 2000-1, a C5a antagonist for the treatment of asthma. Results showed that NGD 2000-1 did not demonstrate a therapeutic benefit in the primary endpoints. The randomized, double-blind, placebo controlled study enrolled 142 subjects with mild to moderate asthma at 16 sites. Subjects were dosed with NGD 2000-1, 10 mg, 60 mg, or 100 mg or placebo, twice daily for 28 days. The primary endpoint was the Forced Expiratory Volume in one second (FEV-1).

June 23, 2003

Britannia Pharmaceuticals reported positive results from a phase II trial investigating Pumactant, a mixture of two naturally occurring phospholipids for the treatment of asthma. Subjects were given a standard bronchial provocation test, during which they inhaled five breaths of increasing concentrations of allergens. Results showed that all subjected achieved no shortness of breath from bronchial constriction within 15 minutes of exposure to the allergen. Effect on late asthmatic responses, occurring 3 to 10 hours after exposure, was also promising. Pumactant showed no significant side effects. The randomized, single blind, placebo controlled, cross-over study enrolled non-smokers and was designed to evaluate the effects of Pumactant on early and late asthmatic responses.

March 17, 2003

Sepracor reported positive results from a post-marketing trial investigating Xopenex (levalbuterol), a (R)-enantiomer of racemic albuterol for the treatment of asthma. Results showed 75 % of pediatric subjects treated with Xopenex reported asthma symptom relief within 30 minutes compared with 49 % using racemic albuterol. In addition, 42 % of subjects reported symptom relief within 15 minutes, compared with 20 % of racemic albuterol users. A 20-minute telephone survey was administered to 118 parents and caregivers of pediatric subjects under 11 years of age, prescribed either nebulized racemic albuterol or Xopenex. The study was conducted by Southern California Research, an affiliate of Allergy and Asthma Associates.

November 11, 2002

Genaera reported results from a phase II clinical trial investigating Lomucin (talniflumate) in subjects with asthma. The open-label, randomized study evaluated 63 subjects with chronic asthma to assess the gastrointestinal and respiratory tolerance of Lomucin, as well as to measure the preliminary effects on symptoms and pulmonary functions. The trial, which treated 42 subjects with Lomucin and 21 with ibuprofen, showed the drug was well tolerated in asthma subjects, with a trend of improved gastrointestinal tolerance compared to ibuprofen. No serious adverse events were reported. A positive efficacy trend was observed among subjects with moderate asthma, indicated by increased residual volume at baseline (indicative of gas trapping in the lung). In half of the subjects studied, Lomucin significantly decreased residual volume by 28%, compared to 13% with ibuprofen, but there were no significant effects on asthma symptoms compared to ibuprofen.

July 22, 2002

Millennium Pharmaceuticals and Taisho Pharmaceutical have discontinued the development of oral MLN977 for chronic asthma based on phase II trial results. The four-week, double-blind, dose-finding trial was conducted at 35 sites and included 193 subjects. Subjects were randomized to receive placebo or 200 mg, 400 mg or 600 mg of MLN977 and dosed once daily. After 14 to 28 days of dosing, MLN977-treated subjects experienced statistically significant improvements in FEV1. However, three subjects experienced elevations in liver enzymes that were most likely drug-related. The effects on liver function were similar to those reported with previously developed 5-lipoxygenase (5-LO) inhibitors; MLN977 is a second generation compound in this class of therapies.

Positive results were reported from a phase IIa trial of Dyax and Debiopharm S.A.'s DX-890 in adult subjects with cystic fibrosis (CF). The trial was implemented in two stages with DX-890 doses given by daily inhalation for 14 days. In the first study segment, seven CF subjects received 7.5 mg of DX-890 per treatment. DX-890 was well tolerated; six subjects completed therapy with no change in pulmonary function tests. Inhibition of elastase in sputum was also observed. In the second study segment, 19 CF subjects received 30 mg of DX-890 per treatment. The drug was once again well tolerated - 11 subjects received a full course of treatment, and for these subjects, pulmonary function tests did not show any adverse changes compared to baseline. These subjects also experienced inhibition of sputum neutrophil elastase following treatment, with seven of the 11 experiencing complete inhibition.

April 29, 2002

Favorable results were obtained from a pilot phase II trial evaluating IPL576,092, a leukocyte suppressing anti-inflammatory drug (LSAID), as an oral treatment for asthma. The double-blind, randomized, crossover trial included male mild asthmatics and compared two doses of IPL576,092 with a placebo. Results showed an improvement with IPL576,092 compared to placebo in the primary endpoint (late-phase bronchoconstriction), although statistical significance was not reached. Additionally, IPL575,092 produced an improvement in airway hyper-reactivity to histamine provocation relative to placebo, as well as a trend towards preventing eosinophil increase in induced sputum. Based on these results, Inflazyme and Aventis are accelerating the development of IPL512,602, a second generation LSAID.

February 11, 2002

Positive results were reported from a large-scale pediatric trial of Sepracor's Xopenex (levalbuterol), an asthma medication that contains only the right isomer of albuterol. In the trial, 319 children ages four to 11 received a placebo, or one of two doses of levalbuterol or racemic albuterol, three times a day for three weeks. Data showed that the lowest dose of levalbuterol (0.31mg) produced a greater improvement in lung function than the recommended dose of racemic albuterol (2.5mg). Additionally, levalbuterol took effect more quickly than racemic albuterol and produced fewer side effects. Levalbuterol is currently approved as a bronchodilator for patients 12 and older.

February 4, 2002

Positive results were reported from a trial of EpiGenesis Pharmaceuticals' EPI-2010, the first of a new class of respiratory drugs called Respirable Antisense Oligonucleotides (RASONs). The trial, which included 14 asthma subjects, was conducted at Hammersmith Medicines Research in London. Results showed that a single dose of EPI-2010 significantly reduced the need to use bronchodilator medicine to control asthma symptoms. Taisho Pharmaceutical is the exclusive licensee of EPI-2010 in Asia.