Asthma - ZaBeCor's Investigational New Drug Application Approved By The FDA

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Nov 2008 - 4:00 PDT

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ZaBeCor Pharmaceuticals ("ZaBeCor" or the "Company") announces today that the United States Food and Drug Administration ("FDA") has approved the Company's Investigational New Drug Application ("IND") for the treatment of asthma. This approval enables the Company to proceed with Phase I clinical trials in humans for its asthma drug candidate, Excellair(TM). The IND review included ZaBeCor's clinical development plan, Phase I clinical trial protocols, manufacturing plans and extensive pre-clinical studies.

Excellair(TM) is part of ZaBeCor's extensive intellectual property and is based upon research conducted at the University of Pennsylvania School of Medicine. Excellair(TM) focuses on applications of siRNA to the molecular protein Syk kinase. The release of biologically active mediators in many inflammatory pathways, including those operable in asthma, is initiated by Syk kinase.

"We are very pleased to have our IND approved by the FDA and we look forward to commencing Phase I clinical trials," said Alan D. Schreiber, M.D., Founder, Chairman and Chief Executive Officer of ZaBeCor. "This is an important milestone for ZaBeCor and indicates confidence in our intellectual property and data. We are delighted to continue the development of our asthma drug candidate, Excellair(TM), which we believe will be a groundbreaking treatment for patients worldwide."

Asthma, a chronic pulmonary disease that makes breathing difficult due to inflammation or blockage of the airway, affects more than 22 million Americans and is a major cause of hospitalization in children. Worldwide, there are approximately 150 million asthmatics.

About ZaBeCor

ZaBeCor Pharmaceuticals is a biotechnology company focused on the development of siRNA, antisense and other molecular technologies for the treatment of asthma, allergy, arthritis, cardiovascular disease and other inflammatory disorders.

ZaBeCor Pharmaceuticals