University Patents, Inc.

Nuc Med Inc.

Serono Laboratories, Inc.

Summa Medical Corporation

David R Crockford

Buck A Rhodes

Scott W Burchiel

F(ab').sub.2 or Fab fragments of antibodies to: (a) human chorionic gonadotropin (hCG), hCG alpha subunit, hCG beta subunit, or an hCG-like material; or (b) other tumor specific or tumor associated molecules, to include carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), human melanoma associated antigens, human sarcoma associated antigens or other antigens, are radiolabeled with technetium-99m (Tc-99m). When the F(ab').sub.2 or Fab fragments of antibody to such tumor associated antigens are injected intravenously into a patient, the radiolabeled composition accumulates at tumor sites. The accumulation of the cancer seeking radiopharmaceutical at tumor sites permits detection by external gamma scintigraphy. Thus, the composition is useful in the monitoring, localization and detection of cancer in the body. In an alternative composition, a double antibody approach to tumor localization using radiolabeled F(ab').sub.2 or Fab fragments is utilized. In this approach, a tumor specific antibody in the form of IgG, F(ab').sub.2 or Fab is first administered to a patient intravenously. Following a sufficient period of time, a second antibody in the form of F(ab').sub.2 or Fab is administered. The second antibody is radiolabeled with Tc-99m and has the property that it is reactive with the first antibody. This double antibody method has the advantage over a single antibody approach in that smaller tumors can be localized and detected and that the total amount of radioactive trace localized at the cancer site is increased.

Composition and method for detecting cancer with technetium labeled

Antibodies to human carcinoembryonic antigen (CEA), human alphafetoprotein (AFP) and/or to other anti-human tumor associated antigens (TAA) labeled with technetium-99m (Tc-99m) are administered to a human after the human has been administered anti-CEA, anti-AFP and/or other anti-TAAs, such as human melanoma-associated antigen, human neuroblastoma-associated antigen, human breast cancer-associated antigen, human ovary-associated antigen, human sarcoma-associated antigen, etc. The biodistribution of the labeled product composition accumulates at cancer sites, e.g., tumors that produce or express TAA, due to the affinity that the antibody has for the given tumor antigen. The accumulation at the tumor site(s) of a suitable amount of Tc-99m associated with the antibody allows detection via external scintigraphy and other means. Detection of the Tc-99m antibody composition by external scintigraphy permits localization and detection of tumors in vivo via a semi-noninvasive technique.

Radiolabeled antibody to anti-tumor associated antigen and process

Proteins are radiolabeled with technetium-99m in a reducing environment comprising buffered stannous chloride wherein the tin utilized to form the stannous chloride is non-oxidized, the buffered stannous chloride is purged of oxygen and the buffer comprises an alkali metal biphthalate and an alkali metal tartrate. Proteins which have been preincubated with tin are radiolabeled with technetium-99m to form a strongly bonded, non-exchangeable radiolabeled tracer substance. The radiolabeling can be accomplished immediately after pretinning, or the pretinned proteins can be freeze-dried and the radiolabeling accomplished at some time in the future when the pretinned proteins are resolubilized in a saline solution of sodium pertechnetate - TC-99m. Pretinning can be accomplished in a reducing environment comprising stannous chloride buffered with an alkali metal biphthalate and an alkali metal tartrate, this solution having been purged of oxygen to assure that the stannous chloride is non-oxidized. When the pretinning proteins are freeze-dried, they can be utilized to prepare instant TC-99m labeling kits for use as radiopharmaceuticals.

Method for radiolabeling proteins with technetium-99m

Anti human chorionic gonadotropin (anti-hCG) and/or anti human chorionic gonadotropin- beta subunit (anti-hCG-.beta.) labeled with Technetium-99M are/is administered to a human. The biodistribution of the labeled composition is monitored in order to determine whether the labeled composition accumulates at cancer sites, e.g. tumors that produce human chorionic gonadotropin (hCG), human chorionic gonadotropin-like material, and a compound similar to and/or identical to the beta-chain of chorionic gonadotropin, or mixtures thereof which would bind specifically to anti-hCG and/or anti-hCG-.beta..

Method and composition for cancer detection in humans

Antibody to anti human chorionic gonadotropin and/or antibody to anti human chorionic gonadotropin-beta subunit labeled with technetium-99m, iodine-123, iodine-125 or iodine-131 are/is administered to a human after the human has been administered anti-hCG and/or anti-hCG beta. The biodistribution of the labeled composition accumulates at cancer sites, e.g. tumors that produce human chorionic gonadotropin (hCG), human chorionic gonadotripin-like material, and a compound similar to and/or identical to the beta-chain of chorionic gonadotropin, or mixtures thereof which would bind specifically to anti-hCG and/or anti-hCG-beta.

Growing community of inventors

Haverhill, MA, United States of America

David R Crockford