GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Kamada Completes Phase-2 Trial of Inhaled AAT in CF

[Data will be reported before year-end, according to this PR. In addition to the trial in CF (the subject of this PR) Kamada’s inhaled AAT is in phase-2 for AAT HD (#msg-25990907) and bronchiectasis (#msg-26698235). Kamada’s injected AAT hit its primary endpoint in a phase-3 trial for CF, but data have not yet been reported (#msg-28121695).

Both Kamada programs rely on plasma-derived AAT. Please see #msg-25174719 and #msg-25848126 for musings on how GTC may eventually be able to break Kamada’s orphan designation for inhaled AAT by virtue of having a recombinant product.]

http://biz.yahoo.com/bw/080821/20080821005531.html

›Thursday August 21, 9:19 am ET

WEIZMANN SCIENCE PARK, NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE: KMDA), 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 company’s flagship AAT product for the treatment of cystic fibrosis. “This is a major milestone for Kamada. There is significant potential for the aerosolized 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 populations.”

About the study

The trial, which was a double-blind, placebo controlled study was performed at the renowned Cystic Fibrosis (CF) Medical Center – Hadassah – Hebrew University Medical Center Mount Scopus in Jerusalem, 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 excellent safety profile of the product. Further trial details are available at www.clinicaltrials.gov.

About Aerosolized AAT

Kamada’s 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 twelve years of exclusive distribution rights, if the company’s 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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