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Data Show Aerovance’s Aerovant™ BERKELEY, Calif., Oct. 7, 2008 – Aerovance Inc. today reported pharmacokinetic (PK) and safety data from a Phase I trial of its Aerovant inhalation powder that demonstrate good tolerability with no evidence of local irritancy following asthma patients’ inhalation of a single 10 mg dose. This 10 mg dose will be the highest of three doses investigated in Aerovance’s Phase IIb dose-ranging study, which is scheduled to begin early next year. Evidence gathered from nonclinical and clinical studies indicates the primary action of Aerovant is local to the lung, while the PK data confirm that the dry powder inhaler achieved the targeted lung dose. The data were presented by E. Burmeister Getz, Ph.D, at the European Respiratory Society (ERS) Annual Congress in Berlin. “We are encouraged by the PK and safety data that demonstrate Aerovant’s potential for treating uncontrolled asthma when delivered as an inhalation powder,” said Mark Perry, Aerovance’s president and chief executive officer. “The conclusions presented, along with our efficacy and safety data from previous clinical studies, validate the benefits of delivering Aerovant directly to the lung. Similar to the most widely used asthma medications, Aerovant will be delivered as a dry powder, a method of administration that doctors and asthma patients have embraced.” Ten subjects with mild-to-moderate asthma participated in the study and were administered a single 10 mg dose of Aerovant inhalation powder via the EZ Aer™ Inhaler. Serial measurements of PK and lung function (FEV1) were collected over a 24-hour period post dosing. Results indicated that time to peak blood concentration was two hours, in agreement with nebulization of 60 mg Aerovant solution. Half-life in the blood, three hours, was similarly unaffected by formulation and dose level. Using blood concentrations as a surrogate measure of lung dose, the PK data estimate a 3.2-mg dose to the lung was achieved, thus hitting the 3-mg targeted dose. Typical changes in FEV1 over a 24-hour period were ≤ 10%. Aerovant is a recombinant human IL-4 variant that is a potent inhibitor of both the IL-4 and IL-13 receptors. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corporation in 2004.
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