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Aeris Therapeutics, Inc. Initiates Phase 2 Trial of Biologic Lung Volume Reduction


4/3/2007 2:04:28 PM

Woburn, MA – April 3, 2007 – Aeris Therapeutics, Inc. (www.aerist.com), a privately-held company, today announced that it has initiated enrollment and treatment of subjects in the Phase 2 clinical trial of its Biologic Lung Volume Reduction (BLVR) System. BLVR is designed to provide a safe non-surgical alternative to lung volume reduction surgery, one of the few available treatments for patients with severe, advanced emphysema.

“We are pleased to announce this milestone in our effort to provide a minimally-invasive bronchoscopic therapy designed to improve lung function and relieve symptoms for patients with advanced emphysema in whom medical therapy is inadequate,” said David Dove, M.D., Aeris’ President and Chief Executive Officer. “Our Phase 1 clinical experience has demonstrated that the BLVR System is well tolerated and has provided initial indications that it may be effective in ameliorating symptoms and improving breathing capacity. Our Phase 2 trials, being conducted in partnership with leading clinical centers across the country, directly address the clinical efficacy of two different BLVR dosing regimens.”

The BLVR Phase 2 clinical trials will enroll a total of 40 patients who will be followed for a period of two years post-treatment. Clinical centers currently participating in the first Phase 2 BLVR clinical trial, and actively screening and enrolling patients, are: Caritas St. Elizabeth’s Medical Center, Boston, MA; Medical University of South Carolina, Charleston, SC; Pulmonary Associates and Lincoln Hospital, Phoenix, AZ; and Temple University Hospital, Philadelphia, PA. Aeris anticipates the addition of 4-5 additional participating clinical centers in the coming weeks. A list of BLVR Phase 2 sites, to be periodically updated as new clinical centers join the trial, may be found on the web by going to www.clinicaltrials.gov and entering “Aeris” in the search box.

About The Biologic Lung Volume Reduction System.

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable gel. The gel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris’ BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs 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.

About Aeris Therapeutics, Inc.

Aeris Therapeutics, Inc. is a specialty bio-pharmaceutical company dedicated to the development and commercialization of innovative therapies that improve the lives of patients with lung disease. The company possesses a fundamental core clinical competence in pulmonary medicine with substantial internal capabilities in basic sciences, preclinical and clinical research, drug delivery, product development, and regulatory affairs.

Aeris’ research and product development efforts currently encompass the areas of interventional pulmonology and targeted delivery of drugs and biologics. Aeris’ lead product is the Biologic Lung Volume Reduction (BLVR) System, a non-surgical treatment for patients with advanced heterogeneous emphysema.

Founded in 2000, Aeris Therapeutics Inc. is privately held, with corporate offices in Woburn, MA.

Press Contact:

David Dove, MD, President & CEO Tel: (781) 937-0110 Email: dove@aerist.com



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