Cancer treatment today is in need of tumor-specific and effective therapies that do not harm the patient and thereby compromise treatment efficacy and prolong recovery time. A multi-modal therapeutic and imaging agent that does not damage healthy living tissue would have tremendous benefit to researchers and victims of this deadly disease. Nanomaterials have the potential to provide the next- generation solutions that are needed, as they offer 1) a unique size range closely matching that of cells (1 to 1,000 nm), 2) a substantial multifunctional capability, and 3) an inherently large surface-to-volume ratio. The proposed research will focus on synthesizing a novel nanomaterial construct and validating its effectiveness. As envisioned, this new construct will offer a multimodal therapeutic advantage by acting simultaneously as an image contrast enhancement agent, a targeted drug-delivery vehicle, a thermal sensitizer, and a generator of singlet oxygen. This research project is specifically designed to address the special NIH STTR Phase I solicitation """"""""Bioengineering Nanotechnology Initiative"""""""" (PA-06-008). The expanded project timeline and budget, our strong preliminary data, and the highly experienced team all combine to directly address the goals of this special NIH solicitation. ADA Technologies has assembled a highly qualified R&D team to execute this challenging project. ADA's Principal Investigator is an expert on nanotechnology and nanometrology; the academic STTR partners at Virginia Tech offer substantial experience and equipment for nanomaterials synthesis and hyperthermia treatment; and the Director of the Comprehensive Cancer Center at Wake Forest University offers his services as an expert consultant on cancer research. Given that a primitive version of the proposed nanostructure has already shown efficacy with prostate cancer cells, we will focus on prostate cancer for the initial proof of concept in Phase I. Phase I tasks are designed to validate our ability to create the new nanomaterial structures and to demonstrate the feasibility of nanomaterials synthesis as well as hyperthermia and reactive oxygen treatments. In vitro tissue representative phantoms and preliminary in vivo models will be assessed. Phase I success will set the stage in Phase II for more-complex nanostructure synthesis (including antibody and drug-delivery targeting) and larger- scale in vivo studies. Within Phase III, we will partner will bio-pharma industry to expedite clinical studies and commercialization of this promising bionanotechnology. Ultimately, this nanostructured material will benefit patients, who will receive a more effective and benign treatment protocol; researchers, who will benefit from a highly effective new multi-modal drug agent; and the bio-pharma industry, which will have a more-marketable product for cancer treatment. The potential worldwide market could reach billions of dollars per year through the research's anticipated application to multiple cancer types. PUBLIC HEALTH REELEVANCE: In an age of major medical advances, tumor-specific, non-toxic and effective therapies against cancer cells do not exist as an option for today's 21st-century patients. Next-generation nanomaterials offer new avenues for more efficacious and harmless options for cancer treatment with their ability to be customized with imaging agents, drug molecules, and highly conducting materials for thermal treatment. The proposed, multi-phase STTR project is focused on developing a new, multi-modal nanomaterial for treating numerous cancer types through its enhanced imaging, improved selectivity of targeted treatment, and minimally invasive therapeutic delivery. ? ? ?