SBIR-STTR Award

Targeted Radioactive Particles for Liver Tumor Therapy
Award last edited on: 6/17/08

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$739,365
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Gilles H Tapolsky

Company Information

FeRx Inc

9171 Towne Centre Drive Suite 575
San Diego, CA 92122
   (858) 677-7788
   N/A
   www.ferx.com
Location: Multiple
Congr. District: 52
County: San Diego

Phase I

Contract Number: 1R43CA088597-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2000
Phase I Amount
$99,598
The ability to deliver high doses of radiation to a tumor without significant damage to surrounding tissue would be a significant advancement in the radiation therapy of solid tumors. FeRx proposes to develop a convenient and safe regimen based on magnetic targeted delivery of radionuclides. Magnetic Targeted Carriers (MTCs) are 0.5 to 1.5 micron microparticles, composed of metallic iron and activated carbon. Using a small externally positioned magnet, MTCs are effectively targeted to a tumor where they are trapped. By irreversibly binding 188Re, a beta emitter radionuclide, to the activated carbon of the MTCs, tumor cells could be safely and effectively irradiated. The combination of a proven targeting technology with an effective radionuclide will lead to a product able to treat a wide variety of tumors in many different organs, with maximal radiation delivered to the tumor and minimal exposure to surrounding tissue. In this proposal we will investigate the feasibility of this project and we plan: 1) to develop and characterize radiolabeled MTCs for their labeling efficiency and labeling stability profile, 2) to evaluate the efficacy of their localization in a rat tumor model, and 3) to evaluate their biodistribution in a normal swine model. PROPOSED COMMERCIAL APPLICATION: Cancer remains one of the leading causes of death in developed countries. While therapies are overall more effective, there is still a tremendous need for less toxic and more effective treatments. The product FeRx proposes to develop would fulfill this need. It would also have a broad range of indications, such as pancreatic, liver, and lung cancers. Commercial opportunities would be very significant. In the lung cancer alone, there was an estimated 171,600 new cases in 1999

Phase II

Contract Number: 2R44CA088597-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2002
(last award dollars: 2003)
Phase II Amount
$639,767

The ability to deliver high doses of radiation (up to 200 Gy and higher) to a tumor without significant damage to surrounding tissue would be a significant advancement in the radiation therapy of solid tumors. FeRx proposes to complete the preclinical and clinical development of targeted radioactive microparticles for the site-specific delivery of radionuclides to liver tumors. Magnetic Targeted Carriers (MTCs) are 0.5 to 5 micron particles composed of metallic iron and activated carbon. Results of SBIR phase I studies indicated that In111, Re188, and Y90 were efficiently and strongly bound to MTCs. Using a small externally positioned magnet, MTCs were effectively targeted to a swine liver where they were trapped. FeRx?s objectives are 1) to perform preclinical studies to support an Investigational Device Exemption submission and 2) to conduct a Phase I/Il safety and tolerability study in patients with liver cancer. In the first year, FeRx will complete the development of (90Y-DOTA)-MTCs, perform biodistribution studies in rabbits and swine, investigate the intra-tumoral biodistribution, and assess the radiotoxicity of high doses of localized radiation. In the second year, FeRx will submit an IDE and commence a phase I/II trial in patients with liver cancer to evaluate safety, tolerability, and preliminary efficacy.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
Biomedical Equipment Development, Drug Delivery System, Liver Neoplasm, Magnetism, Microcapsule, Neoplasm /Cancer Radionuclide Therapy, Radiopharmacology Carbon, Iron, Nonhuman Therapy Evaluation, Pharmacokinetics, Radiotracer Laboratory Rabbit, Swine