Apparatus and Method for Convection Enhanced Therapeutic Delivery

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$125,832.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
1R43CA150521-01A1
Agency Tracking Number:
R43CA150521
Solicitation Year:
2011
Solicitation Topic Code:
NCI
Solicitation Number:
PA10-050
Small Business Information
FHC, INC.
1201 MAIN ST, BOWDOIN, ME, 04287-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
108179458
Principal Investigator:
LEE MARGOLIN
(207) 666-8190
lmargolin@fh-co.com
Business Contact:
LEE MARGOLIN
(207) 666-5651
lmargolin@fh-co.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Malignancies of the brain are among the most devastating diseases known. Glioblastoma multiform (GBM) in particular are known for their rapid, uncontrolled, and aggressive growth. Very little progress has been made in the treatment of GBM over the past 25 years. A more recent promising therapeutic approach is convection enhanced delivery (CED) in which chemotherapeutics are infused under positive pressure and in high volumes directly into the tumor and surrounding tissue. However, the present methods for CED are suboptimal. Large- bore infusion cannulas are used which limit accuracy in placement and result in unacceptable backflow, or reflux , back up along the cannula walls and away from the target. The present application proposes the re- engineering and testing of a CED system (CEDSYS) that addresses these pitfalls. The resulting delivery system may enable effective medicines to be delivered more efficiently, reducing morbidity and mortality in patients with brain cancer. Further, the system and method may have applications to other diseases requiring broad distribution of therapeutic, such as stroke or some neurodegenerative diseases. The overall goal of this phase of the project will be to develop and refine the CEDSYS, ultimately translating it into a well-engineered instrument suitable for human clinical use. The salient innovation of the CEDSYS is as a single device that will marry the capability of precise placement of large volumes of therapeutic via multiple microtubes within discreet brain regions, while incurring minimal reflux of infusate back along the microtubes insertion track. In Phase I proof of concept will be established. Specific project tasks will include: 1.) Design and fabrication of a microtube placement tool, 2.) Adaptation of the FHC microTargetingTM Platform as a means of stereotactic placement and fixation of multiple microtubes, 3.) Assessment of current infusion apparatus and parameters, 4.) Testing of the prototype CEDSYS in an in vitro modelof brain tissue, and 5.) Optimization of design specifications based on test results. The feasibility of this approach will be established if both placement and fixation of multiple microtubes can be demonstrated to be accurate and stable and if infusion can be performed without reflux of infusate. PUBLIC HEALTH RELEVANCE: A diagnosis of malignant brain cancer is essentially a death sentence. The survival time is typically less than a year from the time of diagnosis. It is estimated that in 2009, 22,070 malignant brain tumors will have been diagnosed. The proposed CEDSYS offers a credible option for patients with aggressive malignancies - for which no effective treatment exists.

* information listed above is at the time of submission.

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