Kamada Completes Enrollment In Its Phase II Bronchiectasis Trial With Inhaled AAT

Main Category: COPD
Also Included In: Clinical Trials / Drug Trials;  Medical Devices / Diagnostics;  Respiratory / Asthma
Article Date: 22 Dec 2008 - 2:00 PDT

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Kamada (TASE:KMDA), a biopharmaceutical company engaged in the development, production and marketing of specialty life-saving biotherapeutics, announced recently that it has completed patient enrollment in its Phase II clinical trial evaluating treatment of bronchiectasis patients with inhaled Alpha-1 Antitrypsin (AAT) delivered by the investigational eFlow® nebulizer system (PARI Pharma GmbH).

Chief Executive Officer of Kamada, David Tsur, said, "We are very pleased with the progress of this study and look forward to its upcoming completion. We believe that Kamada's AAT delivered by PARI's eFlow® has the potential to become a novel treatment for bronchiectasis. Kamada is committed to the development of inhaled AAT to treat bronchiectasis and to proceed with its ongoing clinical efforts in Alpha 1 Antitrypsin Deficiency and Cystic Fibrosis."

About the study

A total of 21 patients with brochiectasis were enrolled and randomized into this , double-blind, placebo controlled Phase II study. The purpose of the trial is to investigate safety and efficacy of inhaled AAT in this patient population.

About Kamada's Inhaled AAT

Kamada's AAT product has the advantages of a high purity preparation combined with a liquid, ready to use, presentation that does not include stabilizers or preservatives. Efficacy trends towards reduction in lung inflammation were also shown recently by inhaled AAT in a phase II cystic fibrosis study sided to a high safety profile for the given study period.

Kamada's inhaled AAT, which is delivered via an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH), has received Orphan Drug Designation from the US FDA for the bronchiectasis indication.

About Bronchiectasis

Bronchiectasis is an abnormal stretching and enlarging of the airways. Bronchiectasis patients usually suffer from recurrent, severe episodes of bronchitis, chronic cough and sputum production. According to the US COPD foundation approximately 600,000 individuals suffer from bronchiectasis worldwide, with an estimated 100,000 people in the US alone (excluding cystic fibrosis patients).

About PARI Pharma and the Investigational eFlow® Nebulizer System

Kamada's Inhaled AAT is delivered by the Investigational eFlow Nebulizer System (PARI Pharma GmbH). The Investigational eFlow Nebulizer System uses eFlow Technology to enable extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.

PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow technology. Online at http://www.PariPharma.com.

About Kamada

Kamada is a public biopharmaceutical company (http://www.kamada.com) developing, producing and marketing a line of specialty life-saving biopharmaceuticals using its proprietary chromatographic purification technologies. Several of these specialty therapeutics are currently undergoing advanced clinical trials.

Source:
Eyal Leibovitz
Kamada