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Press Releases
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Kamada Successfully Completes Phase II trial with Aerosolized AAT in Cystic Fibrosis patients |
| August 20, 2008 |
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Weizmann Science Park, Ness Ziona, Israel, August 20 2008 Kamada, a bio-pharmaceutical company (www.kamada.com) engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has completed a Phase II Study with Aerosolized Alpha-1 Antitrypsin (AAT), delivered via an optimized eFlow platform nebulizer (PARI Pharma GmbH), in cystic fibrosis (CF). Preliminary results indicate that the product has an excellent safety profile; final data should be available by year-end 2008.
David Tsur, Kamada's CEO expressed satisfaction at the advancement of the companys flagship AAT product for the treatment of cystic fibrosis This is a major milestone for Kamada. There is significant potential for the aeroslized version of AAT, which is an innovative approach for treatment of chronic inflammatory processes that could potentially prevent degeneration of lung function. We believe that, pending the successful completion of the trials and registration process, this formulation could considerably improve the quality of life and potentially extend the life expectancy of a wide range of cystic fibrosis patients."
According to Pnina Strauss, Kamada's Clinical Trials and IP Manager "We are extremely pleased with this major achievement. Aerosolized administration of AAT for cystic fibrosis holds great potential for the treatment of these severely diseased patients. We are eager to pursue the development of this product and demonstrate the benefit for this patient population as well as other respiratory patient populations.
About the study
The trial, which was a double-blind, placebo controlled study was performed at the renowned Cystic Fibrosis (CF) medical center - Hadassa Hebrew University Medical Center MT Scopus in Jeruslaem, Israel. The trial aimed at validating the safety of the product in CF patients and to assess its potential influence on lung inflammation. The results indicate an impeccable safety profile of the product. Further details are available on www.clinicaltrials.gov.
About Aerosolized AAT
Kamadas Aerosolized AAT, which utilizes an optimized eFlow platform nebulizer (PARI Pharma GmbH), has been designated an Orphan Drug for the treatment of CF and Alpha-1 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 companys product is first on the market. Phase II trials in bronchiectasis are currently ongoing.
About the eFlow Platform Nebulizer
The eFlow platform nebulizer, an electronic, portable nebulizer technology platform, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, the eFlow platform nebulizer 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 amount of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, the eFlow platform nebulizer 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 the eFlow Platform Nebulizer.
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. |
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