The significance of the proposed research is based on the growing demand for healthcare resources to treat and manage prostatic disease, in particular benign prostatic hyperplasia (BPH) and cancer. Prostate cancer is the second-leading cause of cancer deaths among men in the U.S, and both the disease's incidence and cost of treatment for BPH, and its complications, are growing rapidly with the aging U.S. population. There is a clear need for minimally invasive, cost-effective therapies to match the outcomes of surgical treatment options, which are associated with significant morbidity and complications. Prostate injections have not become standard of care due to inadequate drug distribution with needles. The applicants have developed a microporous hollow fiber catheter (MiHFC) for improved injection distribution in the prostate. Phase II innovations focus on combining existing treatment planning methods with MiHFC for drug delivery injections into human prostates with the objective that the system developed will be ready for human clinical use. Hypothesis: The injection system being developed in Phase II, including MiHFC and treatment planning software will give urologists and researchers a more reliable tool to plan and deliver injection therapies into the human prostate. The same MiHFC device with small changes would be adaptable for use in many other human clinical applications needing improved injection systems, such as liver, kidney and other solid organs. This would allow researchers to use MiHFC devices for other research projects involving human drug injections with or without treatment planning. Preliminary Data: In Phase I research, the innovative use of applicant's microporous hollow fiber catheters (MiHFC) to improve injection drug delivery into the prostate was successful with MiHFC significantly improving ethanol distribution in canine prostates as compared to needle injections.
Specific Aims : The objective of this Phase II proposal is to further develop the applicant's innovative drug delivery system for improved prostate disease therapies and to provide the bench and animal study data to accelerate its clinical use.
Aim 1 : Finalize human study catheter design. The Phase I MiHFC design will be optimized to meet human use specifications established from user requirements.
Aim 2 : Infusion studies and analysis. Human ex vivo and baboon in vivo studies will be conducted to assess agent distribution for the development of a treatment planning system.
Aim 3 : Design verification and 510(k) submission. FDA 510(k) clearance will facilitate clinical adoption and commercialization.

Public Health Relevance

There is a significant demand for healthcare resources to treat and manage prostate diseases. The objective of this Phase II proposal is to develop an innovative drug delivery system for improved prostate disease therapies and to provide the bench and animal study data to accelerate its clinical use.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
6R44DK085810-03
Application #
8804067
Study Section
Special Emphasis Panel (UGPP)
Program Officer
Kirkali, Ziya
Project Start
2010-06-01
Project End
2015-06-30
Budget Start
2014-02-01
Budget End
2014-06-30
Support Year
Fiscal Year
2014
Total Cost
$1,360,802
Indirect Cost
Name
Twin Star Tds, LLC
Department
Type
DUNS #
City
Lexington
State
KY
Country
United States
Zip Code
40507