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Phase 1 Trial Initiated With APF530, Potential Treatment for Chemotherapy-Induced Nausea
The clinical study is designed to determine the safety and tolerability of APF530, and will include approximately 18 healthy volunteers at a single clinical site in the United Kingdom. The Company expects to complete this study by mid-year. A.P. Pharma is also finalizing pre-clinical work prior to filing an Investigational New Drug (IND) application in the U.S. that could allow the Company to go directly into U.S. Phase II studies in cancer patients with APF530 later in 2004.
Using the Company's proprietary Biochronomer(TM) bioerodible drug delivery system, APF530 is designed to provide three to five days of continuous relief from chemotherapy-induced nausea and vomiting following a single subcutaneous injection.
APF530 combines A.P. Pharma's Biochronomer drug delivery system with granisetron, one of a class of 5-HT3 antagonists which have revolutionized the treatment of nausea and vomiting during and after chemotherapy. The drug is currently administered by intravenous (IV) injection, followed by oral administration for a number of days. Biochronomer delivery of granisetron is a potential alternative to the IV and subsequent oral administration in the $2 billion annual market for anti-emetics. In animal studies, APF530 incorporating the Biochronomer bioerodible drug delivery system demonstrated sustained release at constant and therapeutically equivalent blood drug levels.
AP Pharma's first Biochronomer product, APF112, is currently in Phase II clinical studies for the treatment of post-surgical pain. APF112 contains the local anesthetic agent mepivacaine and has been shown in a clinical study of 12 patients to sustain blood drug levels up to 72 hours. The product is designed to give pain relief for a sustained period following surgery in order to reduce or eliminate the need for opioid-like-products.
Source: A.P. Pharma, Inc.