A.P. Pharma Provides APF112 Clinical Development Update; Phase II Data Expected by Mid-Year
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jan. 26, 2004--A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today provided an update on the clinical development of its lead product candidate, APF112.
The multi-center Phase II study involving APF112 for the treatment of post-surgical pain, which commenced in the fourth quarter of 2003, is comprised of two parts. In November 2003, the Company indicated that they hoped to complete enrollment of this study in early 2004 and report results shortly thereafter. Recruitment in Part 1 of the study, an open-label safety assessment, was slower than anticipated due to initial caution on the part of clinical investigators that APF112 might interfere with the standard inguinal hernia repair surgery. However, after clinical investigators completed several procedures using APF112, enrollment in the study increased.
According to Dan J. Kopacz, M.D. of Virginia Mason Medical Center and a lead investigator in the APF112 Phase II trial, "Surgeons are often concerned that investigational pain drugs might somehow impede surgery or lead to unforeseen complications after surgery, as has happened in the past. Presuming my experience is typical, following use with APF112 it was clear that the product in no way interferes with surgical technique and did not result in post-surgical complications. Now that clinical investigators have a comfort level with this product, patient recruitment in the clinical trial has ramped up."
Part II of the trial, a 90-patient blinded study comparing two doses of APF112 with current standard treatments for managing post-operative pain, is expected to begin in the near future. A.P. Pharma also announced that it has increased the number of clinical sites able to participate in the study to 12. The Company expects to have preliminary APF112 Phase II clinical data by mid-year. The clinical endpoints for the study include the evaluation of safety and tolerability, a visual analog score of pain intensity, the standard means of measuring pain, and reduction in use of opioid-type pain medication.
APF112 combines A.P. Pharma's proprietary Biochronomer(TM) bioerodible drug delivery system with mepivacaine, an off-patent analgesic. APF112 is designed to provide 24 to 36 hours of pain relief while minimizing the use of opioid-type drugs, which are used extensively in post-operative pain management. Opioids are associated with a number of side effects, such as nausea, sedation, dizziness, constipation, vomiting, urinary retention, and in some situations life-threatening respiratory depression.
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. Initial target areas of application for the Company's drug delivery technology include pain management, anti-nausea, inflammation, oncology and ophthalmology applications. The Company's product development programs are funded by royalties from topical products currently marketed by pharmaceutical partners, by proceeds from the divestitures of its cosmeceutical and analytical standards product lines and by fees it receives from collaborative partners. For further information, visit the Company's web site 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.
A.P. Pharma, Inc.
Gordon Sangster, 650-366-2626
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SOURCE: A.P. Pharma, Inc.