[Talecris had also presented data at the 2007 annual congress of the ERS, demonstrating that using the AKITA2 APIXNEB nebulizer to inhale Prolastin (Alpha1–Proteinase Inhibitor [Human]), results in very high levels of drug deposited in the central and peripheral regions of the lungs. The clinical study data demonstrated that distribution in patients with alpha1-antitrypsin deficiency and cystic fibrosis who had moderate to severe lung function impairment was similar to levels achieved in healthy subjects.]
The results support further clinical development of the drug.
Yossi Nissan 3 Jun 08 14:05
Kamada Ltd. (TASE: KMDA) today reported that interim results of the Phase II clinical trial of the aerosolized version of its Alpha-1 Antitrypsin (AAT) protein for the treatment of emphysema support further clinical development of the drug. The distribution of the active ingredient was in accordance with the target areas in the patients' lungs in the lung deposition test.
Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) have granted aerosolized AAT orphan drug status for the treatment of cystic fibrosis and hereditary emphysema, which is caused by the absence of the AAT protein. The FDA has also granted AAT orphan drug status for the treatment of bronchiectasis.
genisi: According to Kamada’s recent Oppenheimer webcast, IV AAT has a bioavailability to the lung tissue of 2% and inhaled AAT has a bioavailability of almost 100%. However, the amount of AAT per IV dose is only four times greater than the amount of AAT per inhaled dose.
If the 2% figure given on the webcast is correct, why isn’t the amount of AAT per IV dose about fifty times greater than the amount per inhaled dose? T.i.a.
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