Healthcare Industry News:  fast track designation 

Devices Drug Delivery Personnel

 News Release - April 16, 2007

Aeris Therapeutics Strengthens Management Team

May Orfali, MD is Vice President for Clinical Research and Medical Affairs

WOBURN, Mass.--(HSMN NewsFeed)--Aeris Therapeutics, Inc. (www.aerist.com), a privately-held company, today announced that May Orfali, MD has been appointed Vice President for Clinical Research and Medical Affairs. In this newly created position, Dr. Orfali will be responsible for the leadership and management of Aeris' clinical research programs.


Dr. Orfali comes to Aeris Therapeutics with more than 12 years of experience working in the pharmaceutical and medical device industries, providing clinical leadership in a broad range of therapeutic areas. Most recently Senior Medical Director in Clinical Development and Medical Affairs at Cubist Pharmaceuticals, she has also served in leadership positions at the Women's Health Group at Boston Scientific Corporation and Quintiles Transnational Corporation.

"Dr. May Orfali brings a wealth of talent, leadership and proven program management experience to Aeris' clinical research and development efforts. She also complements and adds new breadth and depth to our internal medical resources," said David Dove, M.D., Aeris' President and Chief Executive Officer. "May's prior work with both pharmaceutical and device programs sets her apart, and is particularly important for a combination product like Aeris' Biologic Lung Volume Reduction (BLVR) System. We are very pleased to have her as a member of our team."

"I am excited to join the very talented team at Aeris Therapeutics at such a critical time in the company's development," Dr. Orfali said. "I look forward to helping move the company's product pipeline, most immediately the BLVR System, forward to regulatory approval and commercialization."

A graduate of the Baghdad University School of Medicine, Dr. Orfali trained in pediatric oncology at Massachusetts General Hospital and Children's Hospital, Boston, and served on the research staff of the Dana Farber Cancer Center. She has also held research positions with UNICEF and the World Health Organization.

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.

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 presently in Phase II 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.


Source: Aeris Therapeutics

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.