Status: formerly approved in European countries, never in U.S.; prpduct withdrawn/abandoned

Organizations involved:

KS Biomedix Ltd. – R&D; Tech.; Manuf. other; Europe mark.; Former

Bioreactor Technology, Ltd. – Manuf.; Former

Organon Teknika Corp. - Former

Akzo Nobel N.V. - Parent; Former

Cross ref.: See the Monoclonal Antibodies entry (#300)

Description: HumaSPECT is a radiodiagnostic imaging kit containing votumumab, a recombinant fully human IgG3 kappa monoclonal antibody with specificity for CTAA16.88 tumor-associated antigen expressed by a human lymphoblastoid cell line transformed with Epstein-Barr virus (EBV), radiolabeled with Technetium Tc 99m radioisotope. The votumumab is chemically conjugated to technetium radioisotope prior to injection (reacted with Technetium Tc 99m sodium pertechnetate, as with other Tc-radiolabeled antibodies). Votumumab has specific affinity for a CTAA16.88 (or CTA#1) cytokeratin tumor-associated complex of antigens associated with colorectal adenocarcinomas. Tc 99-radiolabeled votumumab (HumaSPECT) is used for radiodiagnostic imaging of colorectal tumors.

HumaSPECT was the first fully-human monoclonal antibody to be approved for systemic adminstration.

Nomenclature: CTAA16.88 Mab, rDNA–Tc 99m radioconj. [BIO]; HumaSPECT [TR Europe]; votumumab [INN]; CTAA16.88 monoclonal antibody, recombinant–technetium Tc-99m radioimmune conjugate [SY]

Companies.: Originally developed by Organon Teknika, a subsidiary of Akzo Nobel N.V., which obtained the original EU approval. The product was transferred to KS Biomedix Ltd., and apparently was marketed in some European and, perhaps, other countries.

INTRACEL, formerly PerImmune, had U.S. rights.

The crude bulk monoclonal antibody is manufactured by Bioreactor Technology, Ltd. (U.K.) with remaining manufacture by KS Biomedix Ltd. (U.K.). HumaSPECT is marketed in Europe by KS Biomedix.

Status: European Union (EU)-wide approval was granted on Sept. 25, 1998 for colorectal cancer radiodiagnostic imaging. No application for FDA approval has been reported.

In 2003, KS Biomedix declared its intention to not renew the MAA, letting this lapse in Sept. 2003