Phase II year
2011
(last award dollars: 2018)
Phase II Amount
$4,197,137
Over 90% of cancer patients that enroll in Phase I or II clinical trials experience no benefit from the experimental therapies, yet are exposed to drug toxicity and other challenges related to treatment. For over 50 years, physicians have used patient-specific information about drug resistance and sensitivity to select antibiotics for patients with infections, but this personalized approach has evaded the oncology community because cancer cell behavior in vitro drug sensitivity assays does not correlate with in vivo response to therapy in most cases. We have developed technologies that enable oncology drug sensitivity/resistance testing of multiple drugs or drug combinations in vivo during the days prior to surgical resection of a tumor. This approach allows drugs to interact with cancer cells while the latter are in their native tumor microenvironment. Our broad long-term goal is to develop reliable in vivo-based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. Our overall goal of the STTR Phase I and II projects are to develop and test devices that are suitable for human lymphoma patients and to initiate human clinical trials. Our Specific Aim for the Phase I portion is to develop a single use (disposable) porous needle array and demonstrate that it meets drug delivery precision specifications. Provided that quantitative milestones are met in Phase I, Phase II will proceed with the following Aims: Aim 1) To develop a prototype suitable for use in human lymphoma patients; and Aim 2) to conduct a pilot "first in humans" clinical trial. The significance of the proposed work is that it will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. The commercialization potential is described in a comprehensive business plan. We provide letters from highly respected individuals in the biotechnology, life sciences and personalized medicine fields to attest to the commercial potential of this technology.
Public Health Relevance: Project Narrative It is estimated that approximately 1.4 million new cases of cancer will be diagnosed in the United States in 2008. Improved methods for prioritizing cancer therapeutics based on patient-based indicators of efficacy are needed. We are proposing to develop a device which enables comparison of multiple drugs or combinations in vivo, with the tumor micro-environment intact. The long-term goal of this research is to develop reliable in vivo- based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. This technology will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. This personalized treatment approach will improve patient outcome and enhance the quality of care for millions of individuals that suffer from cancer.
Public Health Relevance Statement: Project Narrative It is estimated that approximately 1.4 million new cases of cancer will be diagnosed in the United States in 2008. Improved methods for prioritizing cancer therapeutics based on patient-based indicators of efficacy are needed. We are proposing to develop a device which enables comparison of multiple drugs or combinations in vivo, with the tumor micro-environment intact. The long-term goal of this research is to develop reliable in vivo- based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. This technology will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. This personalized treatment approach will improve patient outcome and enhance the quality of care for millions of individuals that suffer from cancer.
NIH Spending Category: Bioengineering; Biotechnology; Cancer; Clinical Research; Clinical Trials; Lymphoma; Orphan Drug; Patient Safety; Rare Diseases
Project Terms: Address; Antibiotics; base; Biological Assay; Biological Sciences; Biotechnology; Businesses; cancer cell; Cancer Model; Cancer Patient; Caring; cell behavior; chemotherapy; Clinical; Clinical Data; clinical practice; Clinical Trials; cohort; commercialization; Community Clinical Oncology Program; Coupled; Data; Devices; Diagnosis; drug candidate; Drug Combinations; Drug Delivery Systems; Drug resistance; drug sensitivity; Drug toxicity; Engineering; Enrollment; Environment; Excision; experience; Foundations; Frequencies (time pattern); Funding; Goals; Grant; Heterogeneity; Hour; Human; human data; improved; In Vitro; in vivo; Individual; Infection; Investigational Therapies; Journals; Letters; Lymphoma; Malignant Neoplasms; Manuscripts; Marketing; Medical Device; Medical Oncologist; Medicine; meetings; Methods; Mus; Nature; Necrosis; Needles; oncology; Operative Surgical Procedures; Outcome; Pathology; Patients; Pattern; Peer Review; Pharmaceutical Preparations; Phase; Phase I/II Trial; Physicians; Play; pre-clinical; prototype; public health relevance; Publishing; Quality of Care; Research; Research Personnel; Resistance; response; Role; Running; Science; Scientist; Small Business Technology Transfer Research; Solid Neoplasm; Technology; Testing; Therapeutic; Toxic effect; tumor; United States; Work
