Kamada To Start Phase II Clinical Studies Of The Aerosolized Form Of AAT For The Treatment Of Bronchiectasis

Main Category: Respiratory / Asthma
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Feb 2008 - 2:00 PDT

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Kamada (TASE:KMDA), a biopharmaceutical company which develops, manufactures and markets specialty life-saving therapeutics, announces that the company will soon start phase II clinical trials with the inhaled version of its Alpha-1 Antitrypsin (AAT) product to treat Bronchiectasis, a lung disease that results in the distortion of one or more of the conducting bronchi or airways, most often secondary to an infectious process. The study will be conducted using an eFlow® Electronic Nebulizer (PARI Pharma GmbH) optimized for delivery of Kamada's AAT product.

David Tsur, Kamada's CEO, expressed satisfaction at the development of the company's flagship product for the treatment of indications in addition to AAT Deficiency - "there is continuously growing clinical evidence from all over the world indicating that the rationale in treating Congenital Emphysema with AAT is also valid for treating other respiratory diseases. Therefore, development of the product for additional indications is indicated."

Tsur added that "there is significant potential for the inhaled version of AAT, which is an innovative form of treatment that addresses chronic inflammatory reactions and prevents degeneration of lung function. We believe that, pending the successful completion of the trials and registration process, this formulation will both considerably improve the quality of life and extend the life expectancy of a wide range of Bronchiectasis patients. According to research on the subject, there are estimated 100,000 Bronchiectasis patients in the US alone".

"On behalf of the Alpha-1 Foundation as well as the COPD Foundation (representing Bronchiectasis patients), I would like to congratulate Kamada for this significant milestone in its trials for aerosolized delivery of AAT," said John W. Walsh, CEO of the Alpha-1 and COPD Foundations in the US, and added, "the Alpha-1 and COPD Foundations have prioritized the development of aerosolized AAT and are committed to supporting this application."

According to Dr. Charles L. Daley, Chair of the Steering Committee for the COPD foundation's newly formed Bronchiectasis Registry and research consortium, "we see great potential in Kamada's aerosolized AAT product for treating the Bronchiectasis patient population, estimated at 100,000 in the US alone."

Kamada's inhaled AAT has been designated an Orphan Drug for the treatment of CF and AAT Deficiency, in both Europe and the U.S. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and seven to 12 years of exclusive distribution rights, if the company's product is first on the market.

About eFlow®

eFlow, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, eFlow can produce 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 time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow helps reduce the burden of taking daily inhaled treatments.

About PARI Pharma

PARI Pharma develops aerosol delivery devices and inhaled therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma specializes in treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as eFlow.

About Kamada

Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving therapeutics using its proprietary chromatographic purification technologies. Licensed and marketed in more than 15 countries, several of these specialty therapeutics hold registered and pending patents and are currently in advanced clinical trials.

Kamada