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Implantable iontophoresis chemotherapy delivery device for direct infusion ofgemcitabine into pancreatic adenocarcinoma: Device development and First-in-Human clinical trial

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA224460-04
Agency Tracking Number: R44CA224460
Amount: $4,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: CA20-033
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-08-01
Award End Date (Contract End Date): 2023-07-31
Small Business Information
Raleigh, NC 27612-5419
United States
DUNS: 080474527
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 917-7944
Business Contact
Phone: (919) 355-2757
Research Institution

Under the parent grant award 2R44CA224460, Advanced Chemotherapy Technologies (ACT) developed an
Implantable Iontophoresis Chemotherapy Delivery Device (ACT-IOP-003) that facilitates the infusion of a wide
variety of chemotherapy agents directly into the cancer they are intended to treat, thereby minimizing systemic
toxic exposure. ACT continues to focus specifically on treating pancreatic cancer with gemcitabine for this
proposal. Pancreatic cancer has a five-year survival rate of less than 10% and relies on surgery as the only
opportunity for a cure. 40% of patients are not eligible for surgery due to tumor expansion into nearby major
blood vessels or nerves. ACT will implant the device, which delivers the drug using iontophoresis principles,
directly into the tumor, and connect the device to the outside of the body through a catheter terminated in a skin
port. In the parent application and award, ACT has created a clinical quality device based on a pre-clinical device
used in extensive bench top and animal testing, the latter demonstrated very little systemic gemcitabine delivery
when using iontophoresis to target drug delivery to the pancreas while showing marked tumor regression. In
this application, ACT proposes to conduct the first-in-human Phase 1a trial using the ACT-IOP-003 System,
upgrade the preclinical device for laparoscopic implantation, develop an adapted skin port design based on
peritoneal design catheter technology, upgrade their custom DC controller with usability and human factors
improvements, and develop GMP manufacturing processes to produce clinical devices and conduct safety and
efficacy testing to ensure the device is safe for human use. The proposed studies will further serve as the next
critical step in device development and proof-of-concept demonstration of the targeted delivery of the
chemotherapeutic agents by the device increasing the ability of the agent to reach the target while decreasing
systemic impact.

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

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