TC-99M-F(AB)2 Instant Kits for Radioimmunoscintigraphy

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 22297
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1993
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
300 American Road, Morris Plains, NJ, 07950
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Gary L. Griffiths
 (201) 605-8200
Business Contact
Phone: () -
Research Institution
The goal is to develop the optimum clinical agent for radioimmunoscintigraphy. The optimum nuclide is undoubtedly technetium- 99m. Comparing IgG-SH, F(ab')2-SH and Fab'-SH, it is expected that a F(ab')2-SH fragment will have fast enough clearance from circulation to permit earlier imaging than a comparably radiolabeled IgG-SH, while having less renal uptake than a comparably labeled Fab'-SH fragment. Previously, direct labeling of F(ab')2-SH was problematic in that a 50:50 mixture of Tc-99m-F(ab')2 and Tc99m-Fab' would result due to the presence of a small amount of monovalent fragment. We have a novel technique of pre.reducing intact IgG to break non-hinge region disulfide bonds prior to digestion of antibody. The resulting, pure F(ab')2-SH is capable of quantitative incorporation of technetium-99m, in the same manner as IgG-SH and Fab'-SH, are currently labeled to yield quantitatively Tc-99m-F(ab')2. We will extend the technique to different antibodies targeted against different cancers, and ultimately use humanized F(ab')2-SH fragments. In phase l research, we will prove the superiority of Tc99m-F(ab')2 over Tc-99m- Fab' and Tc-99m-IgG as an early time-point radioimmunoimaging agent; if successful, produce clinically usable kits at the conclusion of the Phase II period.

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

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