A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

DESCRIPTION (provided by applicant): Rogers Sciences' mission is to provide effective, low morbidity and cost-effective cancer care through the development and commercialization of therapeutic systems based on Continuous Low Irradiance Photodynamic Therapy (CLIPT). The initial application and proof-of-principle of our technology is the treatment of chest wall progression of breast cancer. While conventional photodynamic therapy (PDT) has been in development and clinical use for over 30 years, it has not gained widespread adoption for a number of reasons including morbidities associated with the therapy, the complexity of administering the required photoactivation energy and the lack of tumor-specificity of the therapy. Our research has addressed these limitations with a new, low irradiance dosimetry approach and novel therapy delivery devices. Low irradiance therapy in human subjects has demonstrated highly specific tumor kill with minimal morbidity and few of the side effects associated with conventional PDT. These promising clinical results are changing thought-leader opinion regarding PDT and have spurred interest from the radiation oncology, medical and surgical oncology communities. Rogers Sciences has developed a 2nd generation prototype CLIPT Systemthat has successfully been used in human clinical trial with highly promising results. In the original CLIPT studies patients were given a 24 hour treatment of CLIPT at the maximum tolerated dose (J/cm2). With additional human and animal CLIPT studies it has been seen that patient outcomes have been improved by either lowering the dose (J/cm2) or reducing the therapy time while maintaining the dose rate (J/hr). Building on the preliminary human trials, the goals of this SBIR Phase II proposal are to refine the CLIPT System and to find the optimal CLIPT treatment dose, dose rate, and dose period. Phase II of the proposed SBIR has two specific aims. The firs aim is to develop a portable CLIPT System for future clinical studies and for commercialization as ahome based device capable of allowing patients to receive CLIPT while performing Activities of Daily Living (ADLs). The second aim is to refine the CLIPT treatment protocol using fractionated treatments commonly used in other modalities of cancer therapy thus allowing RSI to move CLIPT from an in-patient setting to an outpatient or home-based setting. Successful completion of each specific aims will establish the technical and clinical feasibility of the Rogers Sciences CLIPT System for use in the treatment of chest wall progression of breast cancer. Phase III will involve commercial partners to move CLIPT into pivotal trials and to explore the use of CLIPT in treating additional cancer and proliferative diseases. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Post-mastectomy recurrence of breast cancer in the chest wall occurs in 5%-8% of cases, but it occurs more frequently in underserved populations and is highly stage-dependent, with incidence as high as 60% in some patient groups. Many patients have extensive disease that cannot be adequately controlled with conventional treatment and for patients that fail traditional radiation, surgery and chemotherapy, there are few therapeutic options available. This project seeks to develop a novel, low-morbidity approach to treating cancer that can be administered repeatedly and in an outpatient or home-based setting while allowing patients to perform Activities of Daily Living.