Method and system for use in treating a patient with a biological substance to optimize therapy and prevent an adverse response

• US 6,581,607 B2
• Filed: 07/27/2001
• Issued: 06/24/2003
• Est. Priority Date: 07/06/1999
• Status: Expired due to Term

• Current Assignee: Dimensional Dosing Systems Incorporated
• Original Assignee: The Rx Files Corporation
• Inventors: Singer, Michaeal G., Kutzko, John D., McMichael, John P.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/916,411
• Publication Number:
  US 20010042551A1
• Time in Patent Office: 697 Days
• Field of Search: 128/897-98, 600/300, 600/308, 600/347, 600/364-66, 600/368
• US Class Current: 128/898
• CPC Class Codes: A61K 39/0007 Nervous system antigens; Prions
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A method, system and apparatus for use in treating a patient receiving a biological substance, such as a cancer vaccine, to optimize therapy and prevent an adverse response. This system employs surrogate markers or indicators including blood levels of the vaccine to determine the next required dose for a patient. Since the surrogate markers may be employed as a percent change in status, virtually any indicator can be used. Surrogate markers could include any measure of the effectiveness of the vaccine'"'"'s action. Given the effectiveness of the vaccine'"'"'s action relative to the surrogate markers, a change in vaccine dose is calculated by the system. Conversely, by employing this system, one could determine the expected result of the vaccine dose change on the surrogate markers.

Claims

1. A method for calculating a revised dose of a biological substance for a patient using said biological substance, comprising the steps of:

accepting as a first input the patient'"'"'s current biological substance dose;

accepting as a second input a maximum dose of said biological substance;

accepting as a third input a percent response of the patient based on one or more surrogate markers for said patient; and

determining a revised dose, wherein said revised dose is a function of said current dose minus a ratio of the percent response of the patient and a ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

2. The method of claim 1, wherein:

said determining step includes determining said revised dose based on the equation

3. The method of claim 1, wherein:

said biological substance is selected from a group comprising vaccines, serums, drugs, all vitamin antagonists, and all substances derived from and/or related to the foregoing substances.

4. A method for calculating a revised dose of a biological substance for a patient using said biological substance comprising the steps of:

accepting as a first input the patient'"'"'s current biological substance dose;

accepting as a second input the maximum dose of the biological substance;

accepting as a third input one or more numerical markers indicating a response of the patient; and

calculating said revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

5. The method of claim 4, wherein:

said calculating step includes calculating said revised dose based on the equation

6. The method of claim 4, wherein:

said biological substance is selected from a group comprising vaccines, serums, drugs, all vitamin antagonists, and all substances derived from and/or related to the foregoing substances.

7. A method for determining a dose of a biological substance for a patient, comprising the steps of:

administering an initial dose of said biological substance to the patient;

evaluating the patient to monitor and characterize one or more numerical surrogate markers;

determining, based on said numerical surrogate markers, if a dose change for said biological substance is necessary; and

calculating a revised dose as a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

8. The method of claim 7, wherein:

said biological substance is selected from a group comprising vaccines, serums, drugs, all vitamin antagonists, and all substances derived from and/or related to the foregoing substances.

9. A method for determining a dose of a biological substance for a patient, comprising the steps of:

administering an initial dose of said biological substance to the patient;

examining the patient to monitor and characterize one or more numerical surrogate markers;

determining if a dose change is necessary; and

calculating a revised dose as a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

10. A method for calculating a revised dose of a biological substance for a patient currently using said biological substance, comprising the steps of:

accepting as input the patient'"'"'s current biological substance dose;

accepting as input the maximum dose of said biological substance;

accepting as input the percent response of the patient based on surrogate markers; and

calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said percent response of the patient based on said surrogate markers.

11. A method for calculating a revised dose of a biological substance for a patient currently using said biological substance, comprising the steps of:

accepting as input a patient'"'"'s current biological substance dose;

accepting as input a maximum dose of said biological substance;

accepting as input the previous, current and desired values of one or more numerical surrogate markers indicating the response of the patient; and

calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said previous, current and desired values of said numerical surrogate markers.

12. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a predetermined method, comprising:

first means for accepting as input a patient'"'"'s current biological substance dose;

second means for accepting as input a maximum dose of said biological substance;

third means for accepting as input a percent response of a patient based on predetermined surrogate markers; and

calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

13. The storage device of claim 12, wherein:

said biological substance is selected from a group comprising vaccines, serums, drugs, all vitamin antagonists, and all substances derived from and/or related to the foregoing substances.

14. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a predetermined method, comprising:

first means for accepting as input a patient'"'"'s current biological substance dose;

second means for accepting as input the maximum dose of said biological substance;

third means for accepting as input one or more numerical surrogate markers indicating the response of said patient to said biological substance; and

calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in said numerical surrogate markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

15. An apparatus for calculating a revised dose of a biological substance for a patient, comprising:

first means for accepting as input one or more surrogate markers which indicate a patient'"'"'s response to a dose of said biological substance;

second means for accepting as input the patient'"'"'s current biological substance dose;

third means for accepting as input the maximum dose of said biological substance; and

fourth means for calculating a revised dose of said biological substance as a function of said surrogate markers, said current biological substance dose, and said maximum biological substance dose.

16. The apparatus of claim 15, wherein:

said surrogate markers are actual numerical markers.

17. The apparatus of claim 15, wherein:

said surrogate markers are surrogate markers representing a percent response of the patient to said biological substance.

18. The apparatus of claim 15, wherein:

said revised dose is calculated by the equation;

19. The apparatus of claim 15, wherein:

said revised dose is calculated by the equation;

20. The apparatus of claim 15, wherein:

said biological substance is selected from a group comprising vaccines, serums, drugs, all vitamin antagonists, and all substances derived from and/or related to the foregoing substances.

21. A method for calculating a revised dose of a vaccine for a patient using said vaccine, comprising the steps of:

accepting as a first input the patient'"'"'s current vaccine dose;

accepting as a second input a maximum dose of said vaccine;

accepting as a third input a percent response of the patient based on one or more surrogate markers for said patient; and

determining a revised dose, wherein said revised dose is a function of said current dose minus a ratio of the percent response of the patient and a ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

22. The method of claim 21, wherein:

said determining step includes determining said revised dose based on the equation

23. A method for calculating a revised dose of a vaccine for a patient using said vaccine comprising the steps of:

accepting as a first input the patient'"'"'s current vaccine dose;

accepting as a second input the maximum dose of the vaccine;

accepting as a third input one or more numerical markers indicating a response of the patient; and

calculating said revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

24. The method of claim 23, wherein:

said calculating step includes calculating said revised dose based on the equation

25. A method for determining a dose of a vaccine for a patient, comprising the steps of:

administering an initial dose of said vaccine to the patient;

evaluating the patient to monitor and characterize one or more numerical surrogate markers;

determining, based on said numerical surrogate markers, if a dose change for said vaccine is necessary; and

calculating a revised dose as a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

26. A method for determining a dose of a vaccine for a patient, comprising the steps of:

administering an initial dose of said vaccine to the patient;

examining the patient to monitor and characterize one or more numerical surrogate markers;

determining if a dose change is necessary; and

calculating a revised dose as a function of said current dose minus the ratio of the change in said numerical surrogate markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

27. A method for calculating a revised dose of a vaccine for a patient currently using said vaccine, comprising the steps of:

accepting as input the patient'"'"'s current vaccine dose;

accepting as input the maximum dose of said vaccine;

accepting as input the percent response of the patient based on surrogate markers; and

calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said percent response of the patient based on said surrogate markers.

28. A method for calculating a revised dose of a vaccine for a patient currently using said vaccine, comprising the steps of:

accepting as input a patient'"'"'s current vaccine dose;

accepting as input a maximum dose of said vaccine;

accepting as input the previous, current and desired values of one or more numerical surrogate markers indicating the response of the patient; and

calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said previous, current and desired values of said numerical surrogate markers.

29. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a predetermined method, comprising:

first means for accepting as input a patient'"'"'s current vaccine dose;

second means for accepting as input a maximum dose of said vaccine;

third means for accepting as input a percent response of a patient based on predetermined surrogate markers; and

calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

30. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a predetermined method, comprising:

first means for accepting as input a patient'"'"'s current vaccine dose;

second means for accepting as input the maximum dose of said vaccine;

third means for accepting as input one or more numerical surrogate markers indicating the response of said patient to said vaccine; and

calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in said numerical surrogate markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor.

31. An apparatus for calculating a revised dose of a vaccine for a patient, comprising:

first means for accepting as input one or more surrogate markers which indicate a patient'"'"'s response to a dose of said vaccine;

second means for accepting as input the patient'"'"'s current vaccine dose;

third means for accepting as input the maximum dose of said vaccine; and

fourth means for calculating a revised dose of said vaccine as a function of said surrogate markers, said current vaccine dose, and said maximum vaccine dose.

32. The apparatus of claim 31, wherein:

said surrogate markers are actual numerical markers.

33. The apparatus of claim 31, wherein:

said surrogate markers are surrogate markers representing a percent response of the patient to said vaccine.

34. The apparatus of claim 31, wherein:

said revised dose is calculated by the equation;

35. The apparatus of claim 31, wherein:

said revised dose is calculated by the equation;