US 2003/0192560 A1 · Method and apparatus for dosing single and multi-agent therapy

Abstract

An improved method and apparatus using a newly defined nonlinear technology that more accurately describes the biological process of dose titration to calculate next agent dose(s) in single and multi-agent therapy. The overall proportion of each agent is determined by the amount of agent as it relates to the dosing range. The overall proportion as well as the intrinsic potency of the agent is used to determine the total proportional effect that each agent has on the surrogate marker. This parameter is then inserted into the four-parameter equation for calculating dose by adjusting the proportional change in marker that is attributed to the activity of the agent.

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Claims13

Dependent claims

A method for calculating a next dose for each agent of an agent therapy, comprising the steps of:

accepting as first inputs the patient's current dose of an agent which the patient may be using;
accepting as second inputs at least one numerical marker indicating at least one response of the patient;
and
calculating a new agent dose for said agent as a function of said first inputs, said second inputs, and a contribution that each agent makes to an overall effect to be achieved by said multi-agent therapy, wherein said calculating is performed as follows:
To Calculate the Dose for One Agent
NDD=CDD+((% change level/MF))/1+(CDD/drugrange))*CDD
wherein,
% change level=(DDNM−CDNM)/CDNM for regular markers
% change level=(CDNM−DDNM)/CDNM for inverse markers
NDD=New Drug Dose
CDD=Current Drug Dose
CDNM=Current Drug Numerical Marker
DDNM=Desired Drug Numerical Marker
MarkerFunction (MF)=1.5{circumflex over ( )}(CDNM/MarkerRange)
MarkerRange=The maximal range typically seen for the marker:
DrugRange=The maximal range typically prescribed for the drug.
To Calculate the Level/Response for One Agent
NDL=−1*CDL*((NDD*MF*DrugRange+NDD*MF*CDD*MF* DrugRange −1* CDD{circumflex over ( )}2*MF −1*DrugRange*CDD)/(DrugRange*CDD))
wherein,
NDL=New Drug Level
NDD=New Drug Dose
CDL=Current Drug Level
CDD=Current Drug Dose
MarkerFunction (MF)=1.5{circumflex over ( )}(CDNM/MarkerRange)
MarkerRange=The maximal range typically seen for the marker.
DrugRange=The maximal range typically prescribed for the drug.

23 more elements

A method of calculating the best next dose for each agent of a multi-agent therapy which a patient may be using, comprising the steps of:

accepting as first inputs the patient's current doses of a plurality of agents which the patient may be using;
accepting as second inputs one or more numerical markers indicating one or more responses of the patient;
and
calculating new agent doses for said agent or plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.

1 more element

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 first inputs a patient's current doses of a plurality of agents which the patient may be using;
second means for accepting as second inputs one or more numerical markers indicating one or more responses of the patient;
and
third means for calculating new agent doses for said plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.

1 more element

An apparatus for calculating the next best dose for each agent of a multi-agent therapy which a patient may be using, comprising:

first means for accepting as first inputs the patient's current doses of a plurality of agents which the patient may be using;
second means for accepting as second inputs one or more numerical markers indicating one or more responses of the patient;
and
third means for calculating new agent doses for said plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.

1 more element

Dependencies are inferred from the claim text.

Description4,426 words

Summary1,355 words

#The present invention relates generally to a method and apparatus using a newly defined nonlinear technology for multi-agent therapy. More particularly, the present invention relates to a method and apparatus for use in treating a patient with a single or multiple agents to optimize therapy and to prevent an adverse response. The present invention can utilize either biological substance levels or other surrogate markers to determine the effectiveness of the dosing regimen and, if necessary, to suggest a new more optimal regimen.

#The term “agent” as used herein includes, but is not limited to: vaccines; serums; drugs including but not limited to antibiotics, anti-virals, immunosuppressants, anticoagulants; adjuvants to enhance or modulate a resulting immune response; vitamin antagonists; medications; autologous whole-cell vaccines (using cells derived from a patient's own tumor); allogenic whole-cell vaccines (using cancer cell lines established in vitro and then used to vaccinate multiple patients); tumor specific antigen/tumor associated antigen (TSA/TAA) based vaccines and hormonal autoimmunization approaches; all other cancer vaccines; Melacine; CancerVax; immune-boosting interferon; peptides; dendritic cells having melanoma protein thereon; interleukin-12; substances which stimulate or energize blood cells known as CD8 T cells; genes which make interleukin-12; tumor cells weakened by genes which make interleukin-12; substances which block blood-vessel formation to prevent growth of tumors; immunized cells; recombinant subunit vaccines; DNA vaccines; live recombinant viral vector vaccines; live recombinant bacterial vector vaccines; live-attenuated vaccines; whole-inactivated vaccines; virus-like particle vaccines; synthetic peptide vaccines; “Jennerian” vaccines; complex vaccines; and combinations of two or more of the foregoing.

#The term “surrogate marker” as used herein means all surrogate markers and includes, but is not limited to: a measurement of biological activity within the body which indirectly indicates the effect of treatment on a disease state or on any condition being treated; and any measurement taken on or of a patient which relates to the patient's response to an intervention, such as the intervention of a biological substance introduced into or on the patient. For example, CD4 cell counts and viral load are examples of surrogate markers in HIV infection.

Brief description of the drawings2 figures

#FIG. 1 shows a flowchart of the process by which new doses of an agent, of a multi-agent therapy, are determined according to a portion of the method of the invention.

#FIG. 2 shows an apparatus for use in calculating new doses of a plurality of agents used in a multi-agent therapy according to the invention.

Detailed description3,015 words

#FIG. 1 shows a flowchart of a portion of the overall process of treating a patient using this expert system. The actual expert system performs many steps that are described herein, whereas only the steps shown in blocks 10 and 12 are generally indicated the flowchart.

#This expert system includes a general purpose computer, shown in FIG. 2, comprising an input means, preferably a keyboard/text/voice entry device 20 and/or a mouse/pointing/tapping/visual pointing device 22, an output means 30, preferably a video display screen, a data storage means 50, preferably a hard disk drive or non-volatile storage medium, and a processor. The expert computer program receives input from a physician regarding the patient's current drug dose, the doseslope50 value for the drug, the percent response of the patient based on the surrogate markers used to monitor the drug. The doseslope50 value represents the amount of drug a typical patient is on when a 50% change in drug dose results in a 25% change in response or when there is half as much percent response as there is dose change. The embodiment of this invention requires that a physician determine the percentage of response by the patient to the drug based on the surrogate markers for that drug. A relationship is then employed which uses the input parameters described above to determine the next dose for the patient. This invention has two embodiments, one which uses actual numerical surrogate markers to calculate a dose and another embodiment that uses percentages as the numerical input for the surrogate markers.

#The software portion of the invention includes a user interface portion 100 to receive the input data and to output the revised dosage information, and a data analysis portion 110, which calculates the new dosage information based on the input data.

Facts

Application

10/453,749Filed 3 Jun 2003

Priority

24 Aug 2001

Published

16 Oct 2003

Term ends

Not estimatedThe source records don’t support an estimate.

Classification2 codes

A61M 5/16827
Active flow controllers: controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
A61M
Devices for delivering substances into the body

Family

Application09/939,056Continuation in part · filed 24 Aug 2001

Application10/453,749Continuation in part · filed 3 Jun 2003

US 2003/0051736 A1Published application

US 6,578,582 B2Related patent

US 6,883,521 B2Related patent

US 2003/0192560 A1This patent

From the US filing history. Foreign family members aren’t listed.

Method and apparatus for dosing single and multi-agent therapy

Life of this patent

Method and apparatus for dosing single and multi-agent therapy

Life of this patent

Life of this patent

Abstract

Drawings

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Claims13

Description4,426 words

Drawings

Classification2 codes

Life of this patent

Description4,426 words