Nebulizers

PARI Pharma's Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS

Given the preliminary results of the ongoing Phase II trial, treatment with IsoCrom inhaled via a small droplet (MMAD ~ 3.3 microns) Investigational eFlow Nebulizer System has similar effects on asthma control, symptoms, lung function, and FeNO levels as compared to ICS in children with allergic asthma.

"IsoCrom was well tolerated in all children when administered via the Investigational eFlow Nebulizer System," said Prof. Johannes Wildhaber, principal investigator of the study sponsored by the Swiss Pediatric Society.

"These encouraging data may be due to the hygroscopic nature [the ability to attract water molecules] of DSCG, and its tendency to grow in size upon inhalation when administered via a dry powder or metered dose inhaler (DPI or MDI). This assumption is supported by in-vitro study results previously published by PARI Pharma and other studies demonstrating that chymase-positive mast cells primarily located in the distal lungs play a crucial role in asthma. This requires delivery of DSCG via small droplets to the target site in the lungs and can be best achieved by a highly efficient nebulizer, such as the customized small droplet generating eFlow electronic nebulizer," stated Dr. Alexander Moeller, head of the Research Division, Respiratory Medicine at the University Children's Hospital Zurich, Switzerland.

Previous DSCG therapies were only moderately effective, since the interaction of the very hygroscopic properties of DSCG with the drug delivery system were not understood.

"We believe our novel, higher concentrated, low volume DSCG formulation delivered via an optimized Investigational eFlow Nebulizer System opens new treatment avenues and perspectives for patients and physicians. This expectation is further supported by newly published data on a potential antiviral efficacy of DSCG that may be particularly important in the treatment of pediatric asthma," added Dr. Manfred Keller, chief scientific officer and executive vice president of PARI Pharma.

At ATS, PARI Pharma also presented in-vitro data comparing IsoCrom (1%) with a novel, higher concentrated (6%), low volume DSCG formulation that requires significantly less nebulization time than IsoCrom. The results of this in-vitro study using 45mg/0.75ml may allow the option for twice-daily administration in less than 2.5 minutes.

IsoCrom & ICS Comparative Study Results

Data from a randomized, open-label, Phase II, six-month study comparing efficacy and safety of an IsoCrom solution versus inhaled steroids was presented by researchers from the pediatric department of the University Hospital Zurich, Switzerland. Twenty eight children (11.9 +/- 2.8 years) with stable atopic asthma were randomized to inhale either IsoCrom, delivered at a dose of 60 mg per day administered in three inhalations of 2ml using a customized small droplet Investigational eFlow Nebulizer System, or inhaled corticosteroids (ICS) without dose adjustments administered in two inhalations using a metered dose Inhaler (MDI) via a holding chamber.

The study compared various lung function parameters, such as forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC), mean expiratory flow (MEF 50% pred), inflammatory markers, such as serum percent Eosinophils and expired nitric oxide (FeNo), asthma symptom scores, required beta agonist use, and cortisol levels. The mean asthma symptom score decreased significantly in both treatment groups over the 6 month treatment period from 5.2 +/- 2.5 to 3.07 +/- 2.2 (p=0.021) for the ICS cohort and from 5.6 +/- 1.5 to 3.2 +/- 1.9 (p <0.001) for the IsoCrom group, respectively. No significant change in lung function was observed during the six-month treatment with either inhaled corticosteroids or IsoCrom.

PARI's Comparative in-vitro assessment of IsoCrom & a novel 6% DSCG formulation

Sophisticated aerodynamic droplet and particle size assessments in a cascade impactor operated at different humidity levels revealed how delivery and deposition performance of aerosols can be affected. In-vitro breath simulation tests mimicking breathing patterns of 3 and 10 year old children demonstrated drug delivery performance is nearly unaffected when electronic eFlow Technology nebulizers were used for inhalation. The novel 6% DSCG solution may also offer new therapeutic perspectives due to the combined anti-asthmatic and antiviral potency of DSCG.

"Since the relevance of mast cells in lung vascular remodeling and the development of pulmonary hypertension was also demonstrated in an ATS paper by researchers from Canada, Finland and Germany, nebulized DSCG may also be explored as a new therapeutic for the treatment of pulmonary hypertension," stated Dr. Wolfgang M. Kuebler, professor of vascular physiology and pathophysiology at the Charite University Hospital, Berlin, Germany and associate professor at the Department of Surgery of the University of Toronto, Canada.

Keywords: Allergies, Allergy Medicine, Antiviral, Asthma, Biotechnology, Clinical Trial Research, Congenital Lobar Emphysema, Corticosteroid, Drug Delivery, Drug Development, Infectious Disease, Medical Device, Nebulizer, Pediatric, Pediatrics, Pharmaceuticals, Pulmonary Hypertension, Pulmonology, Respiratory Infection, Respiratory Medicine, Treatment, Viral Inhibition, Viral Therapy, Virology, PARI Pharma.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.