A.P. Pharma Reports Initiation of Clinical Program for APF112; First Clinical Study Fully Enrolled
REDWOOD CITY, Calif.--(BW HealthWire)--Jan. 29, 2002--A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today reported the successful completion of its initial Phase I clinical study with APF 112, its lead product candidate for the treatment of post-surgical pain.
The initial clinical study was designed to measure the safety and tolerability of APF 112, and results indicated that APF 112 caused no adverse events in the 16 subjects. A.P. Pharma is currently finalizing the clinical protocol for its Phase IB clinical study. The protocol for a Phase II study is expected to be finalized by mid-2002, with the studies to commence shortly thereafter in major joint surgeries such as open or arthroscopic knee surgery.
Using the Company's Biochronomer(TM) bioerodible drug delivery system, APF 112 is designed to provide 24-36 hours of post-surgical pain relief and to minimize the use of morphine-like drugs (opioids) which are used extensively in post-surgical pain management. Opioids are associated with a wide range of side effects, such as nausea, sedation, dizziness, constipation, vomiting, urinary retention, and in some situations life-threatening respiratory depression.
APF 112 incorporates mepivacaine, a local anesthetic with analgesic properties, which has been used extensively in clinical practice for several years for short-term pain relief. In animal studies, APF 112 incorporating the Biochronomer bioerodible drug delivery system has demonstrated prolonged analgesic effect.
About the Biochronomer System
The Biochronomer system is a unique and versatile family of drug delivery systems specifically designed to provide delivery of drugs over periods from hours to months. The first generation of this family has been designed for the short-term release of pharmacologically active compounds for periods up to one month. This generation of polymers has been the focus of the company for the development of its products and is incorporated as a free-flowing injectable gel in the Company's APF 112.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company focused on the development of ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based drug delivery systems. The Company's primary focus is the development and commercialization of its bioerodible injectable and implantable systems under the trade name Biochronomer(TM). Initial targeted areas of application for the Company's drug delivery technology include pain management, inflammation, anti-adhesion and protein delivery applications. The Company's product development programs are funded by royalties from topical products currently marketed by pharmaceutical partners and proceeds from the divestiture of its cosmeceutical product lines. For further information visit the Company's Website at www.appharma.com.
Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties, including among others, uncertainty associated with timely development, approval, launch and acceptance of new products, establishment of new corporate alliances and progress in research and development programs. Other risks and uncertainties associated with the Company's business and prospects are identified in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.
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A.P. Pharma, Inc.
Gordon Sangster, 650/366-2626