U.S. FDA grants approval to begin phase 3 trial of API
in congenital emphysema patients Clinical Trials

Biotech Business Week

APRIL 6, 2006 - Kamada (KMDA), a developer of prescription drugs, announced that the U.S.  Food and Drug Administration (FDA) has removed the clinical hold status on its alpha 1-proteinase inhibitor (API.)

This announcement is the final approval required by the company to start the third phase of clinical trials with Kamada's flagship alpha 1-proteinase inhibitor drug.
 
The clinical trial will include 50 patients from the U.S. and will follow the protocol submitted to and approved by the FDA.

API is used to treat congenital emphysema, a disease caused by an inborn deficiency of alpha1 protein. The drug is produced by Kamada using the fourth fraction of human plasma. Kamada has already begun the distribution process of API in several countries. API is available without preparation or dilution.

API's new status gives Kamada an advantage in development of the next generation of the product that will be administered by inhalation instead of injection, directly into the patients lungs.

The American Alpha1 organization estimates that more than 200,000 people in the U.S. and Europe suffer from congenital emphysema, with only 10% diagnosed.

Kamada is an Israeli biopharmaceuticals company which develops pharmaceuticals administered by infusion during emergency and trauma situations. The company was founded in 1990.

This article was prepared by Biotech Business Week editors from staff and other reports.

Copyright 2006, Biotech Business Week via NewsRx.com.

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