# US 10,500,274 B2 · Methods for reducing viral load in HIV-1 infected patients > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,274 B2 - Document ID: US10500274B2 - Status: Granted - Kind: B2 - Application number: 13/621,590 - Filed: 2012-09-17 - Published: 2013-08-22 - Granted: 2019-12-10 - Earliest claimed: 2008-04-30 - Assignees: CytoDyn Inc. - Applicants: CytoDyn Inc. - Inventors: William C. Olson; Paul J. Maddon; Daniel C. Pevear; Robert J. Israel; Jose D. Murga - Web page: https://patentgrep.com/patent/US10500274B2 ## CPC - C07K 16/2866: {against receptors for cytokines, lymphokines, interferons} - A61K 39/39541: {against normal tissues, cells} - A61K 39/001121: {Receptors for chemokines} - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - C07K 16/2812: {against CD4} - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract This invention provides a method of reducing viral load in an HIV-1-infected human subject which comprises administering to the subject an effective HIV-1 viral load reducing dose of a CCR5 receptor antagonist, such as a humanized antibody designated PRO 140 or an anti-CCR5 receptor monoclonal antibody, wherein the viral load reducing dose achieves an average maximum decrease of viral load in the subject of at least 1.83 log10 to 2.5 log10 at about ten days following administration of the CCR5 receptor antagonist and wherein the viral load reducing dose further achieves a mean viral load reduction of 1.7 log10 at about nine days following administration of the CCR5 receptor antagonist. ## Claims ### Claim 1 A CCR5 receptor antagonist formulation consisting of a therapeutically effective single subcutaneous dose of a humanized monoclonal antibody designated PRO 140, or a fragment thereof, in an amount 5 mg/kg of body weight for an HIV-infected subject, wherein said formulation results in suppression of HIV-1 viral replication. ### Claim 2 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the PRO 140 comprises (i) two light chains, each light chain comprising the light chain variable (VL) and constant (CL) regions encoded by the plasmid designated pVK:HuPRO140-VK (ATCC Deposit Designation PTA-4097), and (ii) two heavy chains, each heavy chain comprising the heavy chain variable (VH) and constant (CH) regions encoded either by the plasmid designated pVg4:HuPR0140 HG2-VH (ATCC Deposit Designation PTA-4098) or by the plasmid designated pVg4:HuPR0140 (mut B+D+I)-VH (ATCC Deposit Designation PTA-4099), or a fragment thereof. ### Claim 3 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the therapeutically effective dose is about 324 mg. ### Claim 4 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the dose accounts for viral suppression for the HIV-infected subject for about seven days following the last dose. ### Claim 5 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the dosing regimen accounts for viral suppression for the HIV-infected subject for at least two weeks. ### Claim 6 A therapeutic composition comprising a therapeutically effective single subcutaneous or intravenous dose of a CCR5 receptor antagonist in an amount of 5 mg/kg for an HIV-infected subject that results in suppression of HIV-1 viral replication, wherein the CCR5 receptor antagonist is a humanized monoclonal antibody designated PRO 140 or a fragment thereof, or a conjugate of said CCR5 receptor antagonist. ### Claim 7 (depends on 6) The therapeutic composition of claim 6, wherein the CCR5 receptor antagonist comprises (a) a humanized monoclonal antibody designated PRO 140 which comprises (i) two light chains, each light chain comprising the light chain variable (VL) and constant (CL) regions encoded by the plasmid designated pVK:HuPR0140-VK (ATCC Deposit Designation PTA-4097), and (ii) two heavy chains, each heavy chain comprising the heavy chain variable (VH) and constant (CH) regions encoded either by the plasmid designated pVg4:HuPR0140 HG2-VH (ATCC Deposit Designation PTA-4098) or by the plasmid designated pVg4:HuPR0140 (mut B+D+I)-VH (ATCC Deposit Designation PTA-4099), or (b) a fragment thereof. ### Claim 8 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the therapeutically effective single subcutaneous dose does not result in an administration site reaction lasting more than two days. ### Claim 9 (depends on 6) The CCR5 receptor antagonist formulation of claim 6, wherein the therapeutically effective single subcutaneous or intravenous dose does not result in an administration site reaction lasting more than two days. ### Claim 10 (depends on 6) The therapeutic composition of claim 6, wherein the prolonged viral suppression is characterized by about a 1.83 log10 decrease in HIV-1 RNA. ### Claim 11 (depends on 1) The CCR5 receptor antagonist formulation of claim 1, wherein the prolonged viral suppression is characterized by about a 1.83 log10 decrease in HIV-1 RNA. ### Claim 12 A pharmaceutical composition comprising a CCR5 receptor antagonist subcutaneous formulation consisting of a therapeutically effective single subcutaneous dose of a humanized monoclonal antibody (mAb) designated PRO 140, or a fragment thereof, in an amount of 5 mg/kg of body weight for an HIV-1-infected subject, wherein said composition results in suppression of HIV-1 viral replication.