Topical Protector Against Chemo/Radiotherapy

DESCRIPTION: (Verbatim) A National Institutes of Health study has indicated that "hair loss during cancer chemotherapy is probably the most troubling aspect of cancer treatment, it is psychologically debilitating and adds to the overall trauma of the cancer diagnosis and . treatment." We have developed a topically applied pharmaceutical, called ProDermaCel, that has been >95 percent effective in preventing chemotherapy- and radiotherapy-induced alopecia in a rodent model. The goal here is to achieve final refinement of the technology using a rodent model to enable its use in human trials. Our proposed Aims include: i) optimize ProDermaCel dose, application schedule and carrier formulation to eliminate alopecia induced by cytoxan, cytarbine or radiation, ii) determine whether the active chemoprotector molecule in ProDermaCel achieves pharmacologically significant concentrations at organ sites distant from the application site, iii) determine whether topical ProDermaCel application also protects against the dermatitis and mucositis induced by irradiation, and iv). determine whether a newly-discovered chemoprotector molecule, CGO9, shows any activity in a skin carcinogenesis bioassay. In the U.S. alone each year, over one million cancer patients would benefit from the alopecia protection, and several times this number of patients would also benefit from a treatment to prevent radiotherapy-associated dermatitis and mucositis. PROPOSED COMMERCIAL APPLICATION: ProDermaCel, a topically applied pharmaceutical in development, will protect normal, healthy hair follicle cells to prevent The alopecia suffered by cancer and bone marrow transplant patients undergoing chemotherapy or cranial radiotherapy. Other applications for ProDermaCel that are anticipated include protection against dermatitis at an irradiation site, ranging from mild erythema to necrosis, and protection against oral and possibly rectal mucositis associated with radiotherapy.