Aeris Therapeutics Receives FDA Fast Track Designation for Bronchoscopic Lung Volume Reduction System.WOBURN, Mass. -- - Potential of Non-Surgical Emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly Treatment Recognized - Aeris Therapeutics, Inc. (www.aerist.com), a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. , today announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted Fast Track designation for the company's program to develop its Bronchoscopic bron·cho·scope n. A slender tubular instrument with a small light on the end for inspection of the interior of the bronchi. bron Lung Volume Reduction (BLVR BLVR Believer BLVR Bronchoscopic Lung Volume Reduction BLVR Bovine Leukemia Virus Receptor BLVR Block Last Version Reference ) system as a non-surgical treatment alternative for selected patients with advanced heterogeneous emphysema. BLVR is intended to reduce lung volume by delivering proprietary pharmaceutical solutions that form a biodegradable gel to treatment sites within the lung through a standard bronchoscopic procedure. Aeris believes that BLVR has the potential to provide clinical benefits similar to those of lung volume reduction surgery while avoiding the extended recovery period and risks of complications associated with major pulmonary surgery in patients with advanced emphysema. FDA Fast Track Fast Track is a designation of the Food and Drug Administration that accelerates the approval of experimental drugs, such as experimental cancer treatments, that treat a serious or life-threatening medical condition for which no other drug either exists or works as well. designation is reserved for drug and biologic development programs (products under investigation for specific indications) that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation for a clinical program provides a number of procedural benefits designed to facilitate the development and expedite the review of the investigational product. "We view FDA Fast Track designation as an important milestone," said Dr. David Dove, Chief Executive Officer of Aeris Therapeutics, Inc. "It confirms our belief that BLVR has the potential to make a meaningful clinical difference for severely ill patients who currently have very limited treatment options. It also recognizes the potential we've seen to date in our preclinical and clinical safety studies, as well as for our overall clinical development plan as reviewed by FDA." "There is a substantial unmet need for a safe and effective non-surgical treatment for advanced emphysema," Dr. Dove continued. "We look forward to communicating closely with the FDA as we and our clinical partners complete the work required to begin Phase 2 clinical trials at the earliest possible date." About Aeris Therapeutics, Inc. Aeris Therapeutics, Inc., a privately-held company with principal offices in Woburn, MA, was founded in 2000 with the mission to develop innovative treatments that will improve the lives of patients with lung disease. Aeris is conducting research in the fields of interventional pulmonology pul·mo·nol·o·gy n. The branch of medicine that deals with diseases of the respiratory system. pulmonology The study of the lungs and respiratory function , tissue repair, drug delivery, and surfactants. The company's lead product is the Aeris Bronchoscopic Lung Volume Reduction (BLVR) system, a non-surgical treatment for patients with emphysema. Emphysema is a progressive, degenerative disease of the lung that affects more than 3.1 million people in the United States. |
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