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APT Completes Phase I Studies with Aerosolized Hydroxychloroquine for Asthma

11.19.2004

Tucson, Ariz. – Nov 19, 2004

APT Pharmaceuticals has completed a Phase I clinical study in healthy volunteers to determine the safety, pharmacokinetics and taste tolerability of aerosolized hydroxychloroquine (AHCQ). The results showed a favorable safety profile, excellent pharmacokinetics and tolerable taste. The successful completion of the study moves APT forward to financing efforts and efficacy studies.

APT is developing AHCQ as a new class of anti-inflammatory drug for treating asthma, chronic obstructive pulmonary disease, severe acute respiratory syndrome, allergic rhinitis and nasal polyposis.

Hydroxychloroquine is best known as a treatment for malaria. The drug is also classified as a slow-onset disease-modifying antirheumatic drug (DMARD) administered in tablet form as a first-line therapy for systemic lupus erythematosus, rheumatoid arthritis and sarcoidosis. APT’s patented technology is based on targeted administration of aminoquinolines to inflamed tissues. The company’s proprietary aerosolized dosage forms and routes of administration may achieve a faster onset of action and greater therapeutic effect than conventional oral therapy, and at substantially lower systemic doses.

The Phase I study was conducted using the advanced AERx® pulmonary delivery system by Aradigm Corporation of Hayward, Calif., which is designed to maximize drug delivery in a patient-friendly format.

“We are quite pleased with the results of this first study,” said B. Lauren Charous, M.D., director of the Allergy and Respiratory Care Center at Advanced Healthcare in Milwaukee and APT scientific adviser. “The pharmacokinetic data point to a large safety window since plasma concentrations of HCQ following aerosol administration are well below those seen in oral dosing of HCQ to treat lupus and rheumatoid arthritis.”

APT is seeking corporate collaborators or venture investors to participate in the next round of financing.

“Having shown this DMARD is safe when administered by inhalation via the AERx system, APT is focused on closing financing to support Phase II asthma studies and accelerate our development of the rhinitis product,” said APT President Gino Di Sciullo, Ph.D.

Research Corporation Technologies (RCT) in Tucson, Ariz., founded APT Pharmaceuticals to advance development of the AHCQ technology. As the primary investor, RCT funded early formulation work, efficacy studies, preclinical safety studies and continues its support of these clinical trials. U.S. Patent No. 6,572,858 and other pending worldwide patent applications protect the APT technology.