Local disease control is a problem in the management of patients with cancer. Most chemotherapeutic drugs are given to patients systemically as an adjunct to the removal of malignant tumors. Even with radiation therapy, local recurrences too often develop. Sustained or controlled release of drugs directly into wounds after the removal of malignancies may provide control of microscopic residual cancer cells, avoid system toxicity and ameliorate wound healing problems. Development of a programmable, multi-depot chemotherapeutic polymer delivery system is proposed for the treatment of breast cancer. The hypothesis for the investigation is that a bioresorbable delivery device can provide a sustained therapeutic dose of chemotherapy while decreasing system toxicity and delaying or preventing distant metastasis. Furthermore, the device can be engineered to degrade very slowly after it has delivered its payload and act as an in vivo cell culture substratum to direct the pattern of tissue development within the wound. Preliminary results using a prototype have demonstrated the potential of the proposed system.
Specific aims for the Phase I program are to: Design, engineer and fabricate the construct; develop and validate the analytical system needed to obtain a basic drug release profile of the device; and conduct normal in vivo studies to assess device pharmacokinetics, local and systemic effects.
Drug delivery is rapidly becoming an integral part of drug development strategies within the pharmaceutical and biotechnology industries. By the year 2002, revenues of pharmaceutical products which utilize drug delivery systems will reach $35 Billion in the U.S. and $50 Billion worldwide, or 20% of total pharmaceutical sales.
