Lung transplant trial of inhaled Cyclosporine now closed to enrollment

Let's hope the clinical trials discussed in this press release prove to be successful in reducing the rate of chronic rejection in lung transplant recipients, the most common reason for the current 3-year post transplant survival rate of 60 percent with average survival overall less than 5 years.

APT Pharmaceuticals Completes Enrollment in Phase III for Inhaled Cyclosporine

Leading medical centers in North America participate in study to evaluate the safety and efficacy of cyclosporine inhalation solution in preventing chronic rejection in lung transplant recipients.

Burlingame, CA, APT Pharmaceuticals February 24, 2010

APT Pharmaceuticals, a specialty drug development company focused on the development of inhaled cyclosporine, announced today that it has completed enrollment in its Phase III CYCLIST trial. The multi-center, randomized, controlled study enrolled 288 recent lung transplant recipients across 19 leading centers in North America, including the Cleveland Clinic; the University of Pittsburgh; and the University of California, San Francisco.

The objective of the CYCLIST trial is to evaluate the safety and efficacy of cyclosporine inhalation solution in improving bronchiolitis obliterans syndrome (BOS)-free survival following lung transplantation. Lung transplantation is a life-saving procedure for people with end-stage lung diseases who have exhausted all other available treatment options. However, average survival post-lung transplant is less than five years -- significantly less than all other forms of solid organ transplant. Poor long-term outcomes in lung transplant patients appear to relate to BOS, a manifestation of chronic rejection, which remains a persistent problem despite administration of multi-drug systemic immunosuppressive regimens.

"We appreciate the broad support provided by the community of lung transplant centers, advocacy groups, patients and caregivers," said Dr. Charlie Johnson, chief medical officer of APT Pharmaceuticals. "They have exceeded our expectations by enrolling this trial in just over a year."

About Cyclosporine Inhalation Solution

Cyclosporine Inhalation Solution (CIS) is an inhaled formulation of cyclosporine A, an oral medication that has been widely used for over 25 years to prevent rejection in solid organ transplant recipients. Preliminary clinical studies of CIS in lung transplant recipients have been conducted, including a placebo-controlled study that was published as the lead article in the New England Journal of Medicine in January 2006 (Iacono et al 2006). This small, single-center, randomized, controlled, Phase II study showed that administration of inhaled cyclosporine, initiated soon after transplantation, reduced chronic rejection and improved survival while not increasing the risk of infection. This study led to the multi-center, APT Phase III CYCLIST study.

About APT Pharmaceuticals, Inc.

APT Pharmaceuticals, Inc. is focused on the development of cyclosporine inhalation solution (CIS) for the prevention and treatment of chronic rejection in lung transplantation. The company has successfully enrolled a large, multi-center Phase III clinical trial evaluating the effect of CIS on chronic rejection. APT is preparing for study data and commercialization of the product in the US and Europe. Leading life sciences investors Charter Life Sciences, Great Point Partners, InterWest Partners, Pinnacle Ventures, Research Corporation Technologies, Three Arch Partners, Versant Ventures and Vivo Ventures back APT.

Disclaimer

Cyclosporine Inhalation Solution (CIS) is an investigational drug and is not currently approved by the FDA.

For more information about APT, please visit http://www.aptbio.com.

For more information about the CYCLIST trial, please visit http://www.cycliststudy.com.

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