Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product ...

/PRNewswire/ -- Pearl Therapeutics Inc. today announced the advancement of its dual combination product candidate, PT003 and its individual components, PT001 and PT005 into a series of planned Phase 2 studies in patients with moderate-to-severe COPD. PT003 (GFF MDI) is an investigational inhaled combination bronchodilator product comprising glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA), and formoterol (FF), a well-known, established, long-acting beta-2 agonist (LABA), delivered together for the first time via a hydrofluoroalkane metered dose inhaler (HFA MDI), using a proprietary cosuspension formulation approach. These Phase 2 studies are designed to expand findings from the Company's recently concluded Phase 2b study of PT003 and strengthen the safety and efficacy foundation of the Company's Phase 3 program, which is expected to start in late 2012. Specifically they will provide further insight into the individual component doses, compare clinical activity to that of a short-acting anticholinergic agent and assess any cardiovascular effects.

The Phase 2 studies in this series include:

A randomized, double-blind study of four doses of PT001 (GP MDI) compared to placebo and Atrovent® HFA inhalation aerosol, a short-acting muscarinic antagonist; A randomized, double-blind study of three doses of PT005 (FF MDI) compared to placebo and Foradil® Aerolizer®; A randomized, double-blind cardiovascular safety study of PT003, PT005, PT001 and Foradil® Aerolizer®; and A randomized, double-blind study of four doses of PT003 compared with its components, PT001 and PT005.

"With the success of our Phase 2b study of first behind us, we are advancing PT003 and its components without delay in the planned series of four Phase 2 studies," said Chuck Bramlage, an officer of the Pearl direction. "Pearl has set up an iterative and integrated clinical processes and product development that enables us to conduct clinical trials quickly while maintaining a high level of rigor. By combining our new scientific platform with our unique business concept, we have been able to complete an eight-arm, randomized, controlled against placebo and Phase 2b study of PT003 in less than nine months.We expect to complete the four new Phase 2 studies in 12 months, making it the first results available by mid 2012. After the conclusion of these studies, we will meet with the U.S. Food and Drug Administration to review plans for a Phase 3 program for the registration of PT003.

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Using a Metered-Dose Inhaler Puffer A metered dose inhaler, also referred to as an MDI, is a pressurized inhaler that sends medication to the user by a convenient spray. Using an MDI: 1.Be sure to shake the MDI well before using any of the medicine (3 or 4 shakes) 2.Remove the cap of the MDI 3.Exhale, but make sure you face away from the inhaler while breathing out. 4.Draw the MDI to your mouth. As you place the inhaler in between your teeth, make sure to close your mouth around it. 5.Once the MDI is in position, begin to inhale slowly. As you breathe in slowly, press the top of the MDI and continue breathing until you have completed a full breath. Make sure not to exhale right away. 6.Once the medication is administered, remove the MDI from your mouth, but continue holding your breath for roughly 10 seconds. If another dose of medication is required, wait at least 30 seconds and then repeat the steps again. After using the MDI, make sure you rinse you mouth thoroughly, and record how many doses you have taken. Make sure you store all MDIs at room temperature. How to Clean an MDI: In most situations, you will be advised on how to clean your MDI, but if you are still unsure, try these steps: 1.Pull out the canister to remove it. 2.When cleaning the plastic pieces of the MDI use mild soap and water. CAUTION: NEVER WAS THE METAL CANISTER 3.Leave the plastic pieces out until they are completely dry 4.

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