Claims for Patent: 8,894,974

Summary for Patent: 8,894,974

Title:	Radiopharmaceuticals for diagnosis and therapy
Abstract:	A method for treating a human patient is provided, including administering a radiolabeled form of a therapeutic agent to the patient at a first substantially non-therapeutically-effective dose, wherein pharmacological activity of the therapeutic agent is not due to radioactivity of the therapeutic agent. The method also includes determining information related to a biodistribution of the radiolabeled form of the therapeutic agent in the patient by performing a radioimaging procedure on the patient. Responsively to the information, a decision is made whether or not to treat the patient by administering the therapeutic agent to the patient. If the decision is made to treat the patient, the patient is treated by administering the therapeutic agent to the patient at a second therapeutically-effective dose. If the decision is made not to treat the patient, treatment of the patient with the therapeutic agent is withheld. Other embodiments are also described.
Inventor(s):	Rousso; Benny (Rishon-LeZion, IL), Sayada; Chalom Bruno (Luxembourg ville, LU)
Assignee:	Spectrum Dynamics LLC (Orangeburg, NY)
Application Number:	11/747,378
Patent Claims:	1. A method comprising: administering respective radiolabeled forms of a plurality of therapeutic agents to a patient, wherein two or more of the radiolabeled forms of the plurality of therapeutic agents are radiolabeled with a same radiotracer; determining information related to respective biodistributions of the respective radiolabeled forms of the plurality of therapeutic agents in the patient by performing simultaneous functional imaging of the respective radiolabeled forms of the plurality of therapeutic agents during a radioimaging procedure on the patient after administering the respective radiolabeled forms of the plurality of therapeutic agents, wherein performing simultaneous functional imaging of the respective radiolabeled forms of the plurality of therapeutic agents comprises analyzing differing kinetics of the respective radiolabeled forms of the plurality of therapeutic agents; and treating the patient by administering the one or more of the plurality of therapeutic agents to the patient at respective therapeutically-effective doses and withholding administering at least one other of the plurality of therapeutic agents. 2. The method according to claim 1, wherein treating the patient by administering the one or more of the plurality of therapeutic agents to the patient at the respective therapeutically-effective doses comprises treating the patient by administering non-radiolabeled forms of the one or more of the plurality of therapeutic agents to the patient at the respective therapeutically-effective doses, which non-radiolabeled forms of the therapeutic agent are substantially non-radioactive. 3. The method according to claim 1, wherein treating the patient by administering the one or more of the plurality of therapeutic agents to the patient at the respective therapeutically-effective doses comprises treating the patient by administering the radiolabeled forms of the one or more of the plurality of therapeutic agents to the patient at the respective therapeutically-effective doses. 4. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering the respective radiolabeled forms of the therapeutic agents at respective first doses each of which has a total radioactivity per body mass of the patient that is less than 0.05 mCi/kg. 5. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering the respective radiolabeled forms of the plurality of therapeutic agents at respective first doses that are less than the respective therapeutically-effective doses. 6. The method according to claim 5, wherein the respective first doses are less than 10% of the respective therapeutically-effective doses. 7. The method according to claim 6, wherein the respective first doses are less than 1% of the respective therapeutically-effective doses. 8. The method according to claim 7, wherein the respective first doses are less than 0.1% of the respective therapeutically-effective doses. 9. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering each of the radiolabeled forms formed by replacing a non-radioactive isotope of an element of a non-radiolabeled form of the therapeutic agent with a radioactive isotope. 10. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering each of the radiolabeled forms formed by bonding a radioactive radiotracer to the non-radiolabeled form of the therapeutic agent. 11. The method according to claim 1, wherein each of the therapeutic agents is selected from the group consisting of: a protein, an analgesic, an antibiotic, a cardiac drug, a neurological drug, an anti-inflammatory agent, and a non-steroidal anti-inflammatory agent. 12. The method according to claim 1, wherein performing the radioimaging procedure comprises performing a SPECT imaging procedure on the patient. 13. The method according to claim 1, wherein analyzing differing kinetics of the respective radiolabeled forms of the plurality of therapeutic agents comprises determining a time profile of the respective biodistributions of the respective radiolabeled forms of the plurality of therapeutic agents. 14. The method according to claim 13, wherein time profile is an uptake time profile. 15. The method according to claim 1, wherein the plurality of therapeutic agents comprise at least five therapeutic agents. 16. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering the respective radiolabeled forms of the plurality of therapeutic agents at therapeutic doses. 17. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering the respective radiolabeled forms of the plurality of therapeutic agents at respective substantially non-therapeutically-effective doses. 18. The method according to claim 1, wherein administering the respective radiolabeled forms of the plurality of therapeutic agents comprises administering the respective radiolabeled forms of the plurality of therapeutic agents wherein pharmacological activity of the therapeutic agents is not due to radioactivity of the therapeutic agents. 19. The method according to claim 4, wherein administering the respective radiolabeled forms of the therapeutic agents comprises administering the respective radiolabeled forms of the therapeutic agents at respective first doses each of which has a total radioactivity per body mass of the patient that is less than 0.01 mCi/kg. 20. The method according to claim 11, wherein one of the therapeutic agents comprises bevacizumab. 21. The method according to claim 11, wherein one of the therapeutic agents comprises cetuximab.

Details for Patent 8,894,974

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2026-05-11
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2026-05-11
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2026-05-11