Claims for Patent: 8,828,403

Summary for Patent: 8,828,403

Title:	Anti-tumor immunotherapy
Abstract:	The present invention relates to the use of telomerase-derived peptides for the treatment of any cancer patients, particularly for the treatment of patients with renal or prostate cancer.
Inventor(s):	Filaci; Gilberto (Genoa, IT), Indiveri; Francesco (Genoa, IT), Traverso; Paolo (Genoa, IT)
Assignee:	Mediolanum Farmaceutici S.p.A. (Milan, IT)
Application Number:	12/997,630
Patent Claims:	1. A therapeutic method for the treatment of a cancer expressing human telomerase, comprising the following steps: A) administering to a subject in need thereof an antitumoral effective amount of 4 peptides from human telomerase wherein said peptides are: (i) one HLA class I restricted peptide having the following amino acid sequence ILAKFLHWL (SEQ ID NO. 1), (ii) Three HLA class II restricted peptides having the following amino acid sequences: RPGLLGASVLGLDD1 (SEQ ID NO. 2), LTDLQPYMRQFVAHL (SEQ ID. NO. 3) and EARPALLTSRLRFIKP (SEQ ID. NO. 4), in the form of sterile water/oil emulsion wherein the oil component is an adjuvant and consists of: from 88 to 92% by weight of a white mineral oil identified with the CAS Registry No. 8042-47-5, and from 8 to 12% by weight of mannide monooleate, B) administering to the same subject Imiquimod as a further adjuvant, before, contemporaneously or after (A), at the site wherein respectively step (A) will be, is being or was carried out. 2. The therapeutic method of claim 1, wherein said 4 peptides are administered in the form of a unitary water/oil emulsion containing each peptide in an amount of from 100 to 1000 .mu.g. 3. The therapeutic method of claim 1, wherein said cancer expressing human telomerase is selected from renal cancer and prostate cancer. 4. The therapeutic method of claim 1, wherein said water/oil emulsion is administered by intradermal injection. 5. The therapeutic method of claim 2 wherein said water/oil emulsion is administered by a protocol comprising: 1.sup.st week: 3 intradermal injections at intervals of 48 hours; 2.sup.nd-4.sup.th week: 1 injection; 6.sup.th week: 1 injection; 10.sup.th week: 1 injection. 6. The therapeutic method of claim 2, wherein said water/oil emulsion contains each peptide in an amount of from 200-800 .mu.g. 7. The therapeutic method of claim 6 wherein said water/oil emulsion contains each peptide in an amount of from 400-600 .mu.g. 8. The therapeutic method of claim 1, wherein said subject is a human patient positive for HLA alleles corresponding to HLA class I or II alleles restricting presentation of said HLA class I and HLA class II restricted peptides. 9. The therapeutic method of claim 8, wherein said human patient, is positive for the HLA-A2 allele. 10. A vaccine for the treatment of a cancer expressing human telomerase comprising as the active ingredients: (i) one HLA class I restricted peptide having the following amino acid sequence ILAKFLHWL (SEQ ID NO. 1), (ii) three HLA class II restricted peptides having the following amino acid sequences: RPGLLGASVLGLDD1 (SEQ ID NO. 2), LTDLQPYMRQFVAHL (SEQ ID. NO. 3) and EARPALLTSRLRFIKP (SEQ ID. NO. 4), in combination with suitable aqueous excipients and/or diluents, said vaccine being associated with the following adjuvants: (.alpha.) an oily component consisting of: from 88 to 92% by weight of a white mineral hydrocarbon oil identified by the CAS No. 8042-47-5, and from 8 to 12% by weight of a mannide monooleate; and (.beta.) Imiquimod.

Details for Patent 8,828,403

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2028-06-16