Drug Delivery Technology From Advanced Polymer Systems, Inc. Used in Successful Studies for Pre-Cancerous Skin
REDWOOD CITY, CALIF. (April 8) BUSINESS WIRE -April 8, 1999--
400 Patient, Multi-center Phase III Clinical Studies
Demonstrate Safety and Efficacy
Advanced Polymer Systems, Inc. (Nasdaq:APOS) today reported the successful conclusion of clinical studies in the treatment of pre-cancerous skin lesions that demonstrate the safety and efficacy of a 5-fluorouracil product utilizing the Microsponge(R) system.
The unique formulation of 5-fluorouracil utilizing the Microsponge delivery technology demonstrated efficacy in reducing actinic keratoses and was well-tolerated. Dermik Laboratories, Inc. is a partner in the development of this important topical drug product.
In all, 400 patients with actinic keratosis were treated in two separate, well-controlled clinical trials. An actinic keratosis, also known as solar keratosis, is a scaly or crusty bump that arises on the skin surface. Actinic keratoses can be the first step in the development of skin cancer. As a precursor of cancer, if left untreated, they may become malignancies such as squamous cell carcinoma which does have the capacity to metastasize.
"The successful completion by Dermik of the multi-center, Phase III clinical studies using Advanced Polymer's delivery technology is extremely important to our company," said John J. Meakem, Jr., chairman, president and chief executive officer of Advanced Polymer Systems. "It is further proof of the efficacy of our technology in delivering highly effective drugs to treat serious skin conditions."
"Dermik is a first class dermatological partner who is bearing the development expense of this project as part of our agreement and our corporate strategy. We anticipate a substantial return from this relationship in the future as we continue to develop our prescription skin care business," said Meakem.
Based on current demographics in the United States, the incidence of actinic keratosis is expected to increase, and more people will seek treatment. Older people are more likely than younger ones to have actinic keratoses, because cumulative sun exposure increases with the years. A survey of older Americans found keratoses in more than half of all men and more than a third of women aged 65 to 74 who had a high degree of lifetime sun exposure. Some experts believe the majority of people who live to the age of 80 have keratosis.
Advanced Polymer Systems, is a leader in polymer-based delivery systems and related technologies used primarily in ethical and over-the-counter (OTC) pharmaceuticals and personal care products. The company's Microsponge and Polytrap(R) systems, which deliver active ingredients to the skin, now play an integral role in almost 100 personal care products sold worldwide. New products and technologies under development include site-specific systems for delivering oral medications to the lower gastrointestinal tract, and bioerodible microspheres and polymers for oral or implantable drug delivery.
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CONTACT: Ruder-Finn, New York
Lauren Felice, Investor Relations
212/593-6370
or
Advanced Polymer Systems Inc., Redwood City
Gordon Sangster, Controller
650/366-2626
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