Bacterial extract for respiratory disorders and process for its preparation
The present invention relates to an extract from bacterial strains, such as Staphylococcus, Moraxella, Klebsiella, Streptococcus , and Haemophilus . The extract is useful as a treatment for indications such as respiratory disorders, compositions comprising the extract, and processes of making the extract from media that do not pose a risk of prion diseases.
1. An extract which preserves and/or retains saccharide components from one or more bacterial species chosen from Moraxella catarrhalis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes , and Streptococcus sanguinis , wherein, during preparation of said extract, the one or more bacterial species are lysed at a pH of greater than 12, wherein said extract is treated so as to remove nucleic acids to less than 100 μg/ml, wherein one or more amino acids of the proteins of said extract are racemized from L to D, said one or more amino acids being chosen from aspartic acid, asparagine, glutamic acid, glutamine, serine, methionine, histidine, alanine, arginine, phenylalanine, tyrosine, leucine, lysine, valine, and threonine, wherein the extract comprises between 6 and 8 mg/mL of one or more proteins, wherein said one or more proteins has a molecular weight of less than 10 kDa.
2. The extract of claim 1 obtained from each of the following bacterial strains: Moraxella catarrhalis 3622, Moraxella catarrhalis 3625, Moraxella catarrhalis I-045, Haemophilus influenzae 8467, Klebsiella pneumoniae ssp. ozaenae 5050, Klebsiella pneumoniae ssp. pneumoniae 204, Klebsiella pneumoniae ssp. pneumoniae 5056, Staphylococcus aureus I-049, Staphylococcus aureus I-050, Staphylococcus aureus I-051, Staphylococcus aureus I-052, Staphylococcus aureus I-053, Staphylococcus aureus I-054, Streptococcus pneumoniae 7465, Streptococcus pneumoniae 7466, Streptococcus pneumoniae 7978, Streptococcus pneumoniae 10319, Streptococcus pyogenes 8191, Streptococcus sanguinis I-046, Streptococcus sanguinis I-047, and Streptococcus sanguinis I-048.
3. The extract of claim 1 , wherein the extract comprises between 0.3 and 4.5 mg/mL of saccharides.
4. The extract of claim 1 , wherein lysis is performed at a pH of 12.6 to 13.4.
5. The extract of claim 1 , wherein the extract is treated so as to remove particulate and/or insoluble components or both.
6. The extract of claim 1 , wherein the one or more bacterial species is cultured in a medium that does not pose a risk of prion diseases.
7. The extract of claim 1 , wherein the extract comprises between 1.5 and 2.5 mg/mL of free amino acids chosen from aspartic acid, glutamic acid, serine, histidine, alanine, arginine, tyrosine, methionine, phenylalanine, and lysine, and wherein at least one of said free amino acid is racemized by at least 10%.
8. The extract of claim 1 , wherein the free amino acids in the extract comprise between 1 and 80% D-amino acids.
9. The extract of claim 8 , wherein the free amino acids in the extract comprise between 10 and 45% D-amino acids.
10. The extract of claim 9 , wherein the free amino acids in the extract comprise between 25 and 35% D-amino acids.
11. The extract of claim 1 , wherein the extract comprises less than 1000 ng/ml of LPS equivalents according to a limulus amoebocyte lysate (LAL) chromogenic test.
12. The extract of claim 1 , wherein the survival rate of at least 8 mice with wild-type LPS sensitivity 13 days after challenge with Salmonella thyphimurium is at least 70% when treated with said extract for a period of 10 days prior to the challenge, wherein the dose of Salmonella thyphimurium is chosen such that the survival rate of at least 8 control mice treated with water is 60% or lower.
13. The extract of claim 12 , wherein the survival rate of the mice treated with said extract is at least 80%.
14. The extract of claim 13 , wherein the survival rate of the mice treated with said extract is at least 90%.
15. A pharmaceutical composition comprising the extract of claim 1 .
16. A method of treating, preventing a subject suffering from or at risk of developing a respiratory disorder or allergic condition, comprising administering an effective amount of the extract of claim 1 or the pharmaceutical composition of claim 15 to said subject.
17. The method of claim 16 , wherein the subject is a human or domestic mammal.
18. The method of claim 16 , wherein the respiratory disorder or allergic condition is chosen from upper and lower respiratory infections, atopic dermatitis, nasopharyngitis, sinusitis, pharyngitis, tonsillitis, laryngitis, tracheitis, laryngopharyngitis, influenza, pneumonia, bronchopneumonia, bronchitis, lower respiratory infections, allergic rhinitis, allergic asthma, rhinitis, nasopharyngitis, pharyngitis, sinusitis, tonsillitis, laryngitis, laryngotracheitis, bronchitis, obstructive pulmonary disease with acute lower respiratory infection, and obstructive pulmonary disease with acute exacerbation.