IL99485A - Ligands useful in radiographic imaging agents - Google Patents

Ligands useful in radiographic imaging agents

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Publication number
IL99485A
IL99485A IL9948591A IL9948591A IL99485A IL 99485 A IL99485 A IL 99485A IL 9948591 A IL9948591 A IL 9948591A IL 9948591 A IL9948591 A IL 9948591A IL 99485 A IL99485 A IL 99485A
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hydrogen
group
suitable protecting
protecting group
ligand
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IL9948591A
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IL99485A0 (en
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Mallinckrodt Medical Inc
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    • C07K14/815Protease inhibitors from leeches, e.g. hirudin, eglin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04Organic compounds
    • A61K51/0474Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0478Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group complexes from non-cyclic ligands, e.g. EDTA, MAG3
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    • C07D213/00Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/24Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
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    • C07DHETEROCYCLIC COMPOUNDS
    • C07D213/00Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/60Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D213/62Oxygen or sulfur atoms
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    • C07D213/02Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/60Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
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    • C07D213/63One oxygen atom
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    • C07KPEPTIDES
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    • C07K14/575Hormones
    • C07K14/655Somatostatins
    • C07K14/6555Somatostatins at least 1 amino acid in D-form
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2123/00Preparations for testing in vivo

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Description

Ligands useful in radiographic imaging agents MALLINCKRODT MEDICAL, INC.
C. 84436 99485/3 - 1 - Background of the Invention The present invention relates to novel ligands for forming radionuclide complexes.
The use of radiographic imaging agents for visualizing skeletal structures, organs, or tissues, is well known in the area of biological and medical research and diagnostic procedures. The procedure whereby such imaging is accomplished, gene-rally involves the preparation of radioactive ac-ents , which, when introduced to the biological subject, are localized in the specific skeletal structures, organs ox tissues to be studied.
The localized radioactive ageaits may then be traced, plotted or scintiphotographec! by radiation detectors, such as, traversing scanners or scintillation cameras.
The distribution and relative intensity of the detected radioactive agents indicates the position of the tissue in which the agent is localized, and also shows the presence of aberrations, pathological conditions or the like.
In general, the radiographic imaging agents comprise radionuclide-labelled compounds; such as complexes of technetium 99m, rhenium 186 or rhenium 188, or other applicable radionuclides; with appropriate carriers, and auxiliary agents, such as delivery vehicles suitable for injection into, or aspiration by, the patient, physiological buffers and salts, and the like. - 2 - 99485/2 Detailed Description of the Invention The following description includes matter which is not claimed, but is retained herein for the sake of completeness .
The present invention relates particularly to novel aminothiol ligands that are suitable for complexing with a radionuclide, and are useful as general imaging agents for diagnostic purposes. In particular the present invention relates to novel ligands having the general formula : —N—R* wherein R1 and may the same or different and are selected from the group consisting of hydrogen, alkyl, aryl, hydroxyl, alkoxyl, mono- or poly- hydroxyalk l , mono- or poly- alkoxyalkyl, acyl, alkoxycarbonyl , or carbamoyl; A is selected from the group consisting of wherein n is 1 to 3, wherein R3, R4 and R5 are defined in the same manner as R1 and R2 above, and wherein Y is -CH-(CH2)a-S-J or -H wherein m is 1 to 3, wherein Z is selected from the group consisting of 99485/2 3 wherein Rs and R7 are defined in the same manner as R1 and R2 above, and wherein J is hydrogen or another suitable protecting group such as ethylaminocarbonyl; and B is selected from the group consisting of 0 R 0 R 0 II I - CC¾ ) - , -C-C-(CH2) , or -U I - Y Y wherein p is 1 to 3, wherein 1 is 0 or 1, wherein RB and R9 are defined in the same manner as R1 and R2 above, and wherein Y is as defined above.
In a preferred embodiment, ligands according to the present invention have the general formula (I) above, wherein R1 is hydrogen; R2 is selected from the group consisting of butoxycarbonyl , acetyl, ethyl, or hydrogen; A is -(CH2)B- wherein n * 2; and B is O * -C-C-(CH.),- Y wherein 1 = 0, Rs is hydrogen and Y is 2 -CH-(CH2)a-S-J wherein m = 1, Z is -H, and J is a suitable protecting group .
Also novel are ligands having the general formula: wherein R10 is selected from the group consisting of hydrogen, alkyl, aryl, hydroxyl, alkoxyl, mono- or poly-hydroxyalkyl , mono- or poly- alkoxyalkyl, acyl, 99485/2 alkoxycarbonyl , or carbamoyl; R11 is a suitable sulfur protecting group selected from the group defined in the same manner as R10 above; D is selected from the group consisting of wherein i is 1 to 3, wherein R1Z, R13 and Ru are defined in the same manner as R10 above, and wherein X is Q I -CH-(CH2) -S-L wherein g is 1 to 3, wherein Q is selected from the group consisting of wherein R15 and Rlfi are defined in the same manner as R10 above, and wherein L is hydrogen or another suitable protecting group such as eth laminocarbonyl; and E is selected from the group consisting of - (CH2)h- , -C-CH2-NH-C-CH2- , , --Cϋ--CCHH-- ,, or -C-CH - CH- k17 R18 R19 wherein h is 1 to 3, wherein R17, R18 and R19 are defined in the same manner as R10 above.
Other ligands have the general formula (II) above , wherein 10 Is- hydrogen; Ru is 0 // D is -(CHj)j- wherein i The novel ligands described above, may be incorporated into radionuclide complexes used as radiographic imaging agents. The complexes of the present invention are prepared by reacting one of the aforementioned ligands with a radionuclide containing solution under radionuclide complex forming reaction conditions. In particular, if a technetium agent is desired, the reaction* is carried out with a pertechnetate solution under technetium 99m complex forming reaction conditions. The solvent may then be removed by any appropriate means, such as evaporation. The complexes are then prepared for administration to the patient by -dissolution or suspension in a pharmaceutically acceptable vehicle.
The ligands of the present invention may be prepared from commercially available starting materials such as 2- (2-aminoethyl)pyridine, 2-aminomethyl pyridine, homocysteinethiolactone, etc. by standard synthetic methods as described in the following Exaaples 1 - 7.
Radionuclide complexes may have the general formula: (III) 99485/2 6 wherein M is an appropriate radionuclide such as technetium or rhenium, and R1 and R2 are as defined above in formula (I). In a preferred embodiment a technetium radionuclide complex having the general formula (III) may be formed from a pertechnetate solution and a ligand having the general formula (I) above, wherein R1 is hydrogen; R2 is butoxycarbonyl , acetyl, ethyl or hydrogen; A is -(CH,) - wherein n = 2; and B is O R8 -C-C-(CH2),- Y wherein 1 = 0, R* is hydrogen and Y is Z -CH-(CH2)m-S-J wherein m = 1, Z is -H, and J -is a suitable protecting grou .
Also, radionuclide complexes may have the general formula: wherein M represents an appropriate radionuclide, such as technetium or rhenium and wherein R10 is as defined above in formula (II). In a preferred embodiment, a technetium radionuclide complex having the general formula (IV) may be formed from a pertechnetate solution and a ligand having the general formula (II) above, wherein R10 is hydrogen; R11 is D is -(CH2),- wherein i = 1; and E is The radionuclide containing solution nay be obtained from radionuclide generators in a known manner. For example, when forming a technetium complex, the pertechnetate solution may be obtained fron a technetium generator in a known manner. The radionuclide complex forming reaction is then carried out under appropriate reaction conditions. For example, the technetium 99m complex forming reaction is carried out under technetium complex forming temperatures, e.g. 20* C to 100 *C for 10 minutes to several hours. A large excess of the appropriate ligands over the radionuclide complex forming amounts is preferably used. For example, when forming a technetium complex, at least a ten fold excess of the ligands over the pertechnetate solution is used. The pertechnetate is used in technetium complex forming amounts, e.g. about 106 to 1012 molar amounts.
It is believed that certain radionuclide complexes of the present invention incorporating the ligands of the present invention have particular functional use as brain imaging agents. In particular, it is believed that these agents will act as opium alkaloid (e.g. morphine) mimics which may be selectively localized in the brain receptors, and may therefore exhibit optimal properties to function as diagnostic agents for the detection of brain disorders such as Alzheimer's disease, Parkinson's disease, narcotic addiction, etc.
A preferred complex for use in a brain imaging agent has the following formula: wherein. R1 is as defined above in formula (I)/ and wherein Z is a primary, secondary or tertiary amino functionality. This complex may be formed by reaction of a pertechnetate solution with a ligand according to the present invention having the general formula (I) above, wherein R1 is, in particular, hydrogen, hydroxyl, or methoxyl; R2 is CH,; A is R4 R5 3 I I -CH -C- I Y wherein R4 and R5 are hydrogen and Y is Z -CH-(CH2)m-S-J wherein m = 1, Z is ^R6 -N \»' wherein R6 is hydrogen or CH- and R7 is hydrogen or CH3/ and J is a suitable protecting group; and B is O R8 II I -C-C-(CH2),- Y wherein 1 = 1, R8 is hydrogen and Y is -H.
A further preferred complex for use in a brain agent has the following formula: wherein R10 is as defined above in formula (II), and wherein Q is a primary, secondary or tertiary amino functionality.
This complex may be formed by reaction of a pertechnetate solution with a ligand having the general formula (II) above, wherein R10 is, in particular, hydrogen, hydroxyl, or methoxyl; Ru is hydrogen or another suitable protecting group; D is R.13 R14 -CH - C- I X wherein R13 and Rl* are hydrogen and X is Q I -CH-(CH2)g-S-L wherein g = 1, Q is ,R -N ^R16 .wherein R,s is hydrogen or CH3 and R16 is hydrogen or CH3, and L is a suitable protecting group; and E is 0 II -C-CH - CH- R18 R19 wherein R18 and R19 are hydrogen.
Also related to imaging agents containing a radionuclide complex as described above, in an amount sufficient for imaging, together with a pharmaceutically acceptable radiological vehicle. The radiological vehicle should be suitable for injection or aspiration, such as human serum albumin; aqueous buffer solutions, e.g tris (hydromethyl) aminomethane (and its salts), phosphate, citrate, bicarbonate, etc; sterile water; physiological saline; and balanced ionic solutions containing chloride and or dicarbonate salts or normal blood plasma cations such as Ca*2, Na*, K+, and Mg+2.
The concentration of the imaging agent in the radiological vehicle should be sufficient to provide satisfactory imaging, for example, when using an aqueous solution, the dosage is about 1.0 to 50 millicuries. The imaging agent should be administered so as to remain in the patient for about 1 to 3 hours, although both longer and shorter time periods are acceptable. Therefore, convenient ampules containing 1 to 10 ml of aqueous solution may be prepared.
Imaging may be carried out in the normal manner, for example by injecting a sufficient amount of the imaging composition to provide adequate imaging and then scanning with a suitable machine, such as a gamma camera.
The complexes may be prepared in accordance with the examples set forth below.
Example 1 Preparation of 5-aza-3-(N-t-butoxycarbonyl ) amino- 1 - mercapto-4-oxo-7- f 2 -pyridvl ) -heptane A mixture of 2- (2-aminoethyl)pyridine (2.44 g, 0.02 mol) and N-t butoxycarbonyl-homocysteinethiolactone (4.22 g, 0.02 mol) in acetonitrile (50 ml) was heated under reflux for 12 hours. Thereafter, the reaction mixture was kept at room temperature for 6 hours by which time colorless crystals had separated. The solid was collected by filtration, washed with cold acetonitrile, and dried. 13C-NMR (CDC13) 6171.2, 159.3, 155.4, 149.2, 136.4, 123.3, 121.5, 79.9, 53.7, 38.8, 36.9, 34.8, 32.6, 28.3.
Example 2 Preparation of 3-acetamido-5-aza- l-mercapto-4-oxo-7- (2-pyridyl) heptane A mixture of N-acetylhomocysteinethiolactone (4.77 g, 0.03 mol) and 2- (2-aminoethyl) pyridine (3.66 g, 0.03 mol) in acetonitrile (50 ml) was heated under reflux for 12 hours. The solvent was removed under reduced pressure and the residue was treated with ethyl acetate (50 ml). The precipitate was collected, dried and recrystallized from acetonitrile to give colorless solid. 13C-NMR (CDClj) & 171.4, 170.6, 159.4, 149.3, 136.6, 123.4, 121.8, 51.7, 38.5, 36.8, 34.9, 32.7, 22.8.
Example 3 Preparation of 3-amino-5-a2a-l-mercapto-4-oxo-7- (2- pyridyl) heptane A solution of the butoxycarbonyl derivative from Example 1, (4 g) and trifluoroacetic acid (20 ml) was kept at room temperature for 1 hour. The reaction mixture was poured onto ether (500 ml). the precipitate was collected, washed with ether and dried. The compound was pure enough for the next step.
Example 4 Preparation of 5-aza-3-ethvlamino-l-gercapto-4-oxo- 7-(2-pyridyl) heptane A solution of diborane in tetrahydrofuran (1 M, Aldrich) (60 ml) was added dropwise to an ice-cold solution of the diamide of Example 2 (4 g) in tetrahydrofuran (20 ml). After the addition, the reaction mixture was heated under reflux for 2 hours. The reaction mixture was then cooled in an ice bath and excess diborane was decomposed by dropwise addition of ice-cold water. The solution was taken to dryness under reduced pressure and the residue was redissolved in methylene chloride (100 ml) washed with water (2 x 100 ml), dried (Na2S04), filtered and the filtrate was taken to dryness under reduced pressure. The residue was chromatographed over silica gel (200 g) using CH2C12/CH-0H (9:1) as eluent to furnish the desired co«pound as colorless gum (1 g) . nC-NMR (CDC13) 6 174.7, 159.0, 148.9, 137.2, 123.7, 121.9, 61.2, 49.8, 42.3, 38.3, 37.4, 36.8, 20.8, 14.7.
Example 5 Preparation of 7- ( S-benzoyl ) mercapto-2.5-diaza-3.6- dioxo-l-f2-pvridyl) heptane A mixture of S- (benzoyl)mercaptoacetoxy succinimide (1.4 g) and l-amino-3-aza-2-oxo-4-(2-pyridyl) butane (0.8 g) in acetonitrile (20 ml) was stirred at room temperature for 1 hour. The white precipitate was collected, washed with water, dried, and recrystallized from acetonitrile to give 700 mg of colorless solid. 13C-N R (CDC13) & 191.9, 168.9, 156.5, 149.2, 137.0, 136.1, 134.3, 128.9, 127.7, 122.5, 122.0, 44.3, 43.3, 32.5.
Example 6 Tc labelling of the lioand of Example 1 A mixture of the ligand produced in Example 1 (10 mg) in ethanol (0.9 ml) was treated with 0.01 N NaOH (0.1 ml) and technetium tartarate solution (0.1 ml). The entire mixture was heated at 100 *C for 30 ninutes. After cooling, the neutral complex was purified by reverse phase HPLC.
Example 7 "!Tc labelling of the ligand of Example 5 A mixture of the ligand produced in Example 5 (10 mg) in ethanol (0.1 ml) and 0.0001 N NaOH (0.9 ml) and technetium tartarate solution (0.1 ml) was heated at 100 *C for 45 minutes to yield neutral complex in high yield and purity. No HPLC purification was required.
Example 8 Preparation of 5 -aza-3- (N-t-butoxvcarbony1 ) amino- 1 - S-f (N-ethyl carbamoyl 1 mercapto-4-oxo-7- ( 2-pvridvH - heptane A mixture of 2-aminomethyl pyridine (2.44 g, 0.02 mol) and N-t butoxycarbonyl-homocysteinethiolactone (4.22 g, 0.02 mol) in acetonitrile (50 ml) was heated under reflux for 16 hours. Thereafter, the reaction mixture was cooled to room temperature and was treated with ethyl isocyanate (2 ml). The solution was stirred at room temperature for 16 hours. The solvent was removed under reduced pressure and the residue was treated with CH.C1. (50 ml) and water (50ml). The organic layer was separated, washed with water, dried (MgS0), filtered, and the filtrate taken to dryness under reduced pressure to give the desired compound as a pale yellow gum.
Purification by silica gel chromatography (ethyl acetate acetone, 4:1) yeilded pure ligand (1.2g) as an off white solid. 13C-NMR (CDC13) 6 171.6, 156.6, 155.6, 149.0, 136.7, 122.3, 121.7, 80.0, 53.7, 44.6, 36.4, 33.9, 28.3, 26.1, 14.9.
The foregoing has been a discussion of the preferred embodiments of the present invention, but is not intended to limit the invention in any way. Rather, many modifications, variations and changes in detail may be made within the scope of the present invention.

Claims (1)

What is claimed is:
1. A ligand useful in forming radionuclide complexes, said ligand having the general formula: wherein R1 and R may the same or different and are selected from the group consisting of hydrogen, alkyl, aryl, hydroxyl, alkoxyl, mono- or poly- hydroxyalkyl , mono- or poly- alkoxyalkyl, acyl, alkoxycarbonyl , or carbamoyl; A is selected from the group consisting of R3 R4 R5 -(CH2)n- , -C 1- , or -C1H -C1- Y Y wherein n is 1 to 3, wherein R3, R4 and R5 are defined in the same manner as R1 and R2 above, and wherein Y is Z J -CH-(CH2)B-S-J , or -H wherein m is 1 to 3, wherein Z is selected from the group consisting of R6 / -H , -NH, , or -N wherein R6 and R7 are defined in the same manner as R1 and R2 above, and wherein J is a suitable protecting group.; and B is selected from the group consisting of O R8 0 R9 0 If I If I 1/ -(CH2)p- , -0-C-(CH2)r , or -C-C -C- Y Y wherein p is 1 to 3( wherein 1 is 0 or 1, wherein R8 and R9 are defined in the same manner as R1 and R2 above, and wherein Y is as defined above. A ligand according to claim 1, wherein R1 is hydrogen; R2 is butoxycarbonyl; A is -(CH2)n- wherein n = 2; and B is 0 R8 II I -C-C-(CH2),- Y wherein 1 = 0, R8 is hydrogen and Y is Z I -CH-(CH2 ) m- S -J wherein m = 1, Z is -H, and J is a suitable protecting group. A ligand according to claim 1, wherein Rl is hydrogen; R2 is acetyl; A is -(CH2)n- wherein n = 2; and B is O R8 II I -C-C-(CH2)r Y wherein 1 = 0, R8 is hydrogen and Y is Z I -CH-(CH2)m-S-J wherein m = 1, Z is -H, and J is a suitable protecting group. A ligand according to claim 1, wherein R1 is hydrogen; R2 is ethyl; A is ~(CH2)n- wherein n = 2; and B is O R8 II I -C-C-(CH2),- Y wherein 1 = 0 R8 is hydrogen and Y is -CH- (CH2)[n-S-J wherein m = 1, Z is -H, and J is a suitable protecting group. A ligand according to claim 1, wherein R is hydrogen; R2 is hydrogen; A is -(CH2)n- wherein n 2; and B is 0 R8 II I -C-C-(CH2),- Y wherein 1 = 0, R8 i s hydrogen and Y is Z I -CH-(CH2)m-S-J wherein m = 1, Z is -H, and J is a suitable protecting group. the Appl i cants RELNHOLlk COHN AND PARTNERS
IL9948591A 1990-09-14 1991-09-15 Ligands useful in radiographic imaging agents IL99485A (en)

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IL99485A true IL99485A (en) 1995-11-27

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5382654A (en) * 1992-02-05 1995-01-17 Mallinckrodt Medical, Inc. Radiolabelled peptide compounds
US5656253A (en) * 1990-09-14 1997-08-12 Mallinckrodt Medical, Inc. Ligands useful in radiographic imaging
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