Kamada Completes Last Patient Visit In Phase II Bronchiectasis Study With Its Inhaled AAT

Main Category: Respiratory / Asthma
Also Included In: COPD;  Clinical Trials / Drug Trials
Article Date: 19 Mar 2009 - 2:00 PDT

email to a friend   printer friendly   opinions  

Kamada , a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has completed the last patient visit in a Phase II bronchiectasis study with its Inhaled Alpha-1 Antitrypsin (AAT), delivered via an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH). Preliminary results indicate that the product continues to demonstrate a good safety profile; final analysis of airway inflammation and secondary endpoints is expected to be available by mid-year.

David Tsur, Kamada's CEO expressed enthusiasm at the advancement of Inhaled AAT for the treatment of bronchiectasis. "This is another milestone for Kamada in the development of Inhaled AAT. Bronchiectasis affects approximately 600,000 people world-wide1 and we believe our novel approach, which could impact the underlying inflammatory processes, may considerably improve the quality of life of these patients. We look forward to receiving the final data from this study in the coming months," said Mr. Tsur.

According to Pnina Strauss, Kamada's Clinical Trials and IP Manager, "This is the third Phase II clinical trial we have conducted with Inhaled AAT and we continue to observe a very promising safety profile."

About the study

The trial, which was a double-blind, placebo-controlled study, was performed at the Rabin Medical Center, Campus Beilinson in Israel. Twenty one patients were randomized 2:1 to Inhaled AAT or placebo and received the drug daily for 12 weeks.

About Inhaled AAT

Kamada's Inhaled AAT is a high purity alpha-1 antitrypsin preparation that Kamada manufactures using sophisticated, in house developed chromatographic purification methods. The inhaled AAT that utilizes an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH), has been designated an Orphan Drug for the treatment of bronchiectasis, alpha-1 deficiency and cystic fibrosis, in the U.S. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and seven years of exclusive distribution rights, if the company's product is first on the market.

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 highly 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, products incorporating eFlow Technology reduce 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 PariPharma.com.

About Kamada

Kamada is a public biopharmaceutical company (TASE: KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals using its proprietary chromatographic purification technologies. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials.

1 COPD Foundation

Source
Kamada

• Additional
• References
• Citations