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PHASE I -TOPIC 431 - DRUG DELIVERY BY ENDOESOPHAGEAL LAVAGE (EEL) TO TREAT ESOPHAGEAL CANCER

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91022C00018
Agency Tracking Number: 75N91022C00018
Amount: $455,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 431
Solicitation Number: PHS-2022-1
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
4408 WASHBURN AVE SOUTH
MINNEAPOLIS, MN 00005-5410
United States
DUNS: 116996412
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BRIAN CRAIG
 (612) 219-7655
 brian@isolatherapeutics.com
Business Contact
 BRIAN CRAIG
Phone: (612) 219-7655
Email: brian@isolatherapeutics.com
Research Institution
N/A
Abstract

Cancer is the second leading cause of death in the United States and esophageal cancer has the 6th lowest survival rate for all cancers. Systemic drug therapy is first-line therapy for widely metastatic esophageal cancer, but is limited by systemic toxicity, patient eligibility, or cost. The proprietary Isola system consists of a drug delivery catheter, tubing, heating element, and a drug lavage solution. A proof-of concept animal study demonstrated that Isola can deliver drug directly to esophageal tissue while minimizing drug in plasma by using balloons to isolate the esophagus from the gastrointestinal track when a drug solution is delivered in the lumen of the esophagus.The goal of is to treat cancerous tumors (adenocarcinoma and squamous cell carcinoma) in the esophagus while minimizing systemic drug exposure and toxicity.The objective of this proposal is to advance activities to eventually complete a first in human (FIH) study using the Isola drug delivery system by a) finalizing the drug delivery system design and selecting the ideal drug for delivery b) completing device design verification and biocompatibility testing to use drug delivery system in humans and c) conducting comparative chronic animal studies to compare Isola drug delivery to standard intravenous drug delivery.

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

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