Preparation of a Therapeutic Composition

Abstract

A pharmaceutical composition includes a peptide nucleotide composition including Peptide A and Peptide B. Peptide A may be characterized by having SEQ. ID NO: 1. Peptide A may also be characterized by including 31 amino acids lacking any cysteine-cysteine cross links and including six spaced-out proline residues and four glutamine residues. Peptide B may be characterized by having SEQ. ID NO: 2. Peptide B may also be characterized by including 21 amino acids attached at a seine residue in position 18 to a diadenine (3′-5′) diribonecleotide through a diphosphodiester linkage at the 3′-position.

1 . A pharmaceutical composition comprising a peptide nucleotide composition including Peptide A and Peptide B, said Peptide A having 31 amino acids lacking any cysteine-cysteine cross links and including six spaced-out proline residues and four glutamine residues, said Peptide B having 21 amino acids attached at a seine residue in position 18 to a diadenine (3′-5′) diribonecleotide through a diphosphodiester linkage at the 3′-position. 
     
     
         2 . A pharmaceutical composition according to  claim 1 , wherein said Peptide A includes SEQ ID NO: 1 and said Peptide B includes SEQ ID NO: 2. 
     
     
         3 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition does not include material greater than 14 kDa molecular weight. 
     
     
         4 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition further comprises a plurality of nucleoside/nucleotide compounds. 
     
     
         5 . A pharmaceutical composition according to  claim 1 , wherein said plurality of nucleoside/nucleotide compounds includes three nucleosides, two nucleoside diphosphates, and eight nucleoside monophosphates. 
     
     
         6 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition is formed by a process comprising:
 forming a mixture including a protein combination consisting of casein, beef peptone, bovine serum albumin, an RNA, and a base in water, wherein the ratio of said protein combination to said water is in a range from about 1.5/100 to about 2.5/100 by weight;   processing said mixture at an elevated temperature and an elevated pressure so as to form a solution and insoluble elements;   removing said insoluble elements;   diluting said solution with water; and   after performing said processing, said removing, and said diluting, adjusting eh pH of said solution to a physiologically acceptable pH.   
     
     
         7 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition is formed by a process comprising:
 suspending about 35.0 grams of casein, about 17.1 grams of beef peptone, about 22.0 grams of ribonucleic acid (RNA), and about 3.25 grams of bovine serum albumin in about 2.5 liters of water;   adding about 11.75 ml of hydrochloric acid to the mixture from said suspending step;   autoclaving the product from said adding step at about 9 lbs pressure and 200-230° F. until the RNA is completely digested;   cooling the product from said autoclaving step to about 3-8° C.;   sequentially filtering the product from said cooling step through a 2 micron filter, a 0.45 micron filter and a 0.2 micron filter;   diluting the product from sequentially filtering step with water to yield a final volume of about 5 liters;   adjusting the pH of the product from said diluting step to a range of about 7.3 to 7.6;   filtering the product from said adjusting the pH step through a second 0.2 micron filter; and   autoclaving the product from said filtering the product step at 240° F. and 20-30 pounds pressure for about 30 minutes.   
     
     
         8 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition is formed by a process comprising:
 suspending about 35.0 grams of casein, about 17.1 grams of beef peptone, about 22.0 grams of ribonucleic acid (RNA), and about 3.25 grams of bovine serum albumin in about 2.5 liters of water;   adding about 16.5 grams of sodium hydroxide to the mixture from said suspending step;   autoclaving the product from said adding step at about 9 lbs pressure and 200-230° F. until the RNA is completely digested;   cooling the product from said autoclaving step to about 3-8° C.;   sequentially filtering the product from said cooling step through a 2 micron filter, a 0.45 micron filter and a 0.2 micron filter;   diluting the product from sequentially filtering step with water to yield a final volume of about 5 liters;   adjusting the pH of the product from said diluting step to a range of about 7.3 to 7.6;   filtering the product from said adjusting the pH step through a second 0.2 micron filter; and   autoclaving the product from said filtering the product step at 240° F. and 20-30 pounds pressure for about 30 minutes.   
     
     
         9 . A pharmaceutical composition according to  claim 1 , further comprising a pharmaceutically acceptable carrier. 
     
     
         10 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition is effective to increase the production of monocyte chemotactic protein 1. 
     
     
         11 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition is effective to increase the production of interleukin-8. 
     
     
         12 . A pharmaceutical composition according to  claim 1 , wherein said peptide nucleotide composition absorbs light at wavelengths 230 nm, 260 nm, and 280 nm so as to result in 260 nm/280 nm absorption ratio of about 1.998 and 260 nm/230 nm absorption ratio of about 1.359. 
     
     
         13 . A pharmaceutical composition comprising a peptide nucleotide composition including Peptide A and Peptide B, said Peptide A having SEQ. ID NO: 1 and Peptide B having SEQ. ID NO: 2. 
     
     
         14 . A pharmaceutical composition according to  claim 13 , wherein Peptide B further includes a diadenine (3′-5′) diribonecleotide attached at a seine residue in position 18 of SEQ. ID NO: 2 through a diphosphodiester linkage at the 3′-position. 
     
     
         15 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition does not include material greater than 14 kDa molecular weight. 
     
     
         16 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition is formed by a process comprising:
 forming a mixture including a protein combination consisting of casein, beef peptone, bovine serum albumin, an RNA, and a base in water, wherein the ratio of said protein combination to said water is in a range from about 1.5/100 to about 2.5/100 by weight;   processing said mixture at an elevated temperature and an elevated pressure so as to form a solution and insoluble elements;   removing said insoluble elements;   diluting said solution with water; and   after performing said processing, said removing, and said diluting, adjusting eh pH of said solution to a physiologically acceptable pH.   
     
     
         17 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition is formed by a process comprising:
 suspending about 35.0 grams of casein, about 17.1 grams of beef peptone, about 22.0 grams of ribonucleic acid (RNA), and about 3.25 grams of bovine serum albumin in about 2.5 liters of water;   adding about 11.75 ml of hydrochloric acid to the mixture from said suspending step;   autoclaving the product from said adding step at about 9 lbs pressure and 200-230° F. until the RNA is completely digested;   cooling the product from said autoclaving step to about 3-8° C.;   sequentially filtering the product from said cooling step through a 2 micron filter, a 0.45 micron filter and a 0.2 micron filter;   diluting the product from sequentially filtering step with water to yield a final volume of about 5 liters;   adjusting the pH of the product from said diluting step to a range of about 7.3 to 7.6;   filtering the product from said adjusting the pH step through a second 0.2 micron filter; and   autoclaving the product from said filtering the product step at 240° F. and 20-30 pounds pressure for about 30 minutes.   
     
     
         18 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition is formed by a process comprising:
 suspending about 35.0 grams of casein, about 17.1 grams of beef peptone, about 22.0 grams of ribonucleic acid (RNA), and about 3.25 grams of bovine serum albumin in about 2.5 liters of water;   adding about 16.5 grams of sodium hydroxide to the mixture from said suspending step;   autoclaving the product from said adding step at about 9 lbs pressure and 200-230° F. until the RNA is completely digested;   cooling the product from said autoclaving step to about 3-8° C.;   sequentially filtering the product from said cooling step through a 2 micron filter, a 0.45 micron filter and a 0.2 micron filter;   diluting the product from sequentially filtering step with water to yield a final volume of about 5 liters;   adjusting the pH of the product from said diluting step to a range of about 7.3 to 7.6;   filtering the product from said adjusting the pH step through a second 0.2 micron filter; and   autoclaving the product from said filtering the product step at 240° F. and 20-30 pounds pressure for about 30 minutes.   
     
     
         19 . A pharmaceutical composition according to  claim 13 , further comprising a pharmaceutically acceptable carrier. 
     
     
         20 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition is effective to increase the production of monocyte chemotactic protein 1. 
     
     
         21 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition is effective to increase the production of interleukin-8. 
     
     
         22 . A pharmaceutical composition according to  claim 13 , wherein said peptide nucleotide composition absorbs light at wavelengths 230 nm, 260 nm, and 280 nm so as to result in 260 nm/280 nm absorption ratio of about 1.998 and 260 nm/230 nm absorption ratio of about 1.359. 
     
     
         23 . A pharmaceutical composition comprising a peptide nucleotide composition including Peptide A and Peptide B, said Peptide A having SEQ. ID NO: 1 and Peptide B having SEQ. ID NO: 2, said peptide nucleotide composition not including material greater than 14 kDa molecular weight, wherein said peptide nucleotide composition is effective to increase the production of monocyte chemotactic protein 1 and interleukin-8 in cultured cells. 
     
     
         24 . A pharmaceutical composition according to  claim 23 , wherein Peptide B further includes a diadenine (3′-5′) diribonecleotide attached at a seine residue in position 18 of SEQ. ID NO: 2 through a diphosphodiester linkage at the 3′-position.