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Sideport Needle Array Technologies for Prioritizing Drugs for Cancer Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42CA144104-01
Agency Tracking Number: R42CA144104
Amount: $164,492.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NCI
Solicitation Number: PHS2010-2
Timeline
Solicitation Year: 2010
Award Year: 2010
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
530 Fairview Avenue North
Seattle, WA 98109-5553
United States
DUNS: 828848908
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JAMES OLSON
 (206) 667-7955
 JOLSON@FHCRC.ORG
Business Contact
 THANE KREINER
Phone: (206) 667-4868
Email: gmail@fhcrc.org
Research Institution
 Fred Hutchinson Cancer Research Center
 
1100 FAIRVIEW AVE N PO BOX 19024
SEATTLE, WA 98109-1024
United States

 () -
 Domestic Nonprofit Research Organization
Abstract

DESCRIPTION (provided by applicant): 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.

* Information listed above is at the time of submission. *

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