The contract research organization says the data will take longer than expected to validate.
On Friday, Kamada Ltd. (Nasdaq: KMDA); TASE: KMDA) announced that it was postponing publication of the results of a clinical trial. The company, which develops therapeutics on the basis of proprietary plasma-derived proteins for orphan indications, announced that it expects to report top-line data from the pivotal Phase II/III clinical trial in Europe and Canada of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD or Inherited Emphysema) by the end of April or the beginning of May. Previously the Company expected to report the data by the end of the first quarter of 2014.
Kamada has been informed by the Contract Research Organization (CRO) conducting this trial that it has taken longer than anticipated to validate the multitude of data points generated by this trial and the delay in reporting top-line data does not reflect on the quality and integrity of the results or the conduct of the trial. The database, which is currently unlocked, is set to be locked in the coming weeks, after which, validation, quality assurance and quality control procedures and statistical analysis will be conducted.
Published by Globes [online], Israel business news - www.globes-online.com - on March 23, 2014
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