Therapies for treating oral mucositis with polyclonal anti-tnfalpha antibodies

Use of an antibody in the manufacture of a medicament for treating oral mucositis, wherein the antibody is an intact blood-derived ovine polyclonal antibody or an intact blood-derived equine polyclonal antibody that binds to a human tumour necrosis factor α (TNFα).

A method of treating oral mucositis, the method comprising administering an antibody composition to a subject, wherein the antibody composition comprises intact blood-derived ovine polyclonal antibodies or intact blood-derived equine polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα).

The antibody composition for use, use or method according to any one of the preceding claims, wherein at least 10% of the total antibodies present in the composition bind to TNFα.

The antibody composition for use, use or method according to any one of the preceding claims, wherein the antibody composition or medicament is formulated as a liquid, preferably as a mouthwash.

The antibody composition for use, use or method according any one of the preceding claims, wherein the antibodies are present at a concentration of 1-100 g/L.

The antibody composition for use, use or method according any one of the preceding claims, wherein the antibodies are present at a concentration of 1-25 g/L (preferably about 5-10 g/L).

The antibody composition for use, use or method according to any one of the preceding claims, wherein a single dose comprises 1 g or less of the antibodies.

The antibody composition for use, use or method according to any one of the preceding claims, wherein a single dose comprises 0.25 g or less of the antibodies.

The antibody composition for use, use or method according to any one of the preceding claims, wherein a single dose comprises 0.01 to 0.25 g of the antibodies.

The antibody composition for use, use or method according to any one of the preceding claims, wherein the antibody composition is administered to a subject at least twice daily.

The antibody composition for use, use or method according to any one of the preceding claims, wherein the antibody composition is administered to a subject four times daily.

The antibody composition for use, use or method according to any one of the preceding claims, wherein a subject treated for oral mucositis is undergoing chemotherapy, radiotherapy or a combination thereof.

The antibody composition for use, use or method according to any one of the preceding claims, wherein the composition of the invention is maintained in the mouth of a subject for a suitable time and then ejected (e.g. not swallowed).

The antibody composition for use, use or method according to any one of the preceding claims, wherein the composition of the invention is not consumed (e.g. swallowed) by a subject administered said composition.

A liquid composition for treating oral mucositis comprising:

• a. intact blood-derived ovine polyclonal antibodies or intact blood-derived equine polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα);
• and
• b. a buffer, a protein stabilizer, a non-ionic surfactant, an antiseptic, a suspending agent, a dispersing agent, a binding agent, an emulsion stabilizer, a sweetener, and a flavourant.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the intact blood-derived polyclonal antibodies are intact blood-derived ovine polyclonal antibodies.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the intact blood-derived equine polyclonal antibodies are intact blood plasma-derived equine polyclonal antibodies.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the antibodies or composition have not been affinity purified.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the antibodies or composition have been subjected to a precipitation (and optionally filtration) step only.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the composition is a blood serum composition that has been subjected to a precipitation (and optionally filtration) step only.

The antibody composition for use, use, method or liquid composition according to one of the preceding claims, wherein the composition is an ovine blood serum composition comprising intact blood-derived ovine polyclonal antibodies that bind to a human TNFα and that has been subjected to a precipitation (and optionally filtration) step only.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the composition is a blood plasma composition that has been subjected to a precipitation (and optionally filtration) step only.

The antibody composition for use, use, method or liquid composition according to any one of the preceding claims, wherein the composition is an equine blood plasma composition comprising intact blood-derived equine polyclonal antibodies that bind to a human TNFα and that has been subjected to a precipitation (and optionally filtration) step only.