Claims for Patent: 10,351,615

Summary for Patent: 10,351,615

Title:	Methods of treatment with long-acting growth hormone
Abstract:	Use of a growth hormone protein and polynucleotides encoding same comprising an amino-terminal carboxy-terminal peptide (CTP) of chorionic gonadotrophin and two carboxy-terminal chorionic gonadotrophin CTPs attached to the growth hormone in methods of inducing weight loss or body fat reduction, methods of increasing insulin-like growth factor (IGF-1) levels, and methods of reducing the dosing frequency of a growth hormone in a human subject are disclosed. Pharmaceutical compositions comprising the growth hormone and polynucleotides encoding the growth hormone of the invention and methods of using same are also disclosed.
Inventor(s):	Fares; Fuad (Hourfish Village, IL), Fima; Udi Eyal (Dvira, IL)
Assignee:	OPKO Biologics Ltd. (Kiryat Gat, IL)
Application Number:	14/236,509
Patent Claims:	1. A method of treating growth hormone deficiency in a human adult subject as measured by maintaining insulin-like growth factor (IGF-1) levels within a normal therapeutic range in said growth hormone deficient human subject, the method comprising administering to said human adult subject a therapeutically effective amount of a CTP-modified polypeptide consisting of (i) a human growth hormone, (ii) a single chorionic gonadotropin carboxy terminal peptide (CTP) attached to the amino terminus of said growth hormone, and (iii) two chorionic gonadotropin CTPs attached to the carboxy terminus of said growth hormone, wherein optionally (iv) a signal peptide is attached to the amino terminus of said amino terminal CTP, measuring IGF-1 levels to determine the maintenance of IGF-1 in said human adult subject, wherein said CTP-modified polypeptide consists of the amino acid sequence set forth in amino acids 27-301 of SEQ ID NO: 11 when said signal peptide is not attached, wherein said therapeutically effective amount consists of a single dose of approximately 1.8-2 mg/week of the CTP-modified polypeptide, wherein said administration maintains IGF-1 levels within a normal therapeutic range and treats said growth hormone deficient human subject. 2. The method of claim 1, wherein said CTP-modified polypeptide is administered at a dose of approximately 2 mg/administration. 3. The method of claim 1, wherein said CTP-modified polypeptide is administered subcutaneously to said subject. 4. The method of claim 1, wherein said CTP-modified polypeptide is encoded by the nucleotide sequence set forth in SEQ ID NO: 16. 5. The method of claim 1, wherein at least one CTP is glycosylated. 6. The method of claim 1, wherein said maintaining is for at least one week. 7. The method of claim 1, wherein the amino acid sequence of said signal peptide is set forth in SEQ ID NO: 3. 8. The method of claim 1, wherein said CTP-modified polypeptide is administered at a dose of approximately 1.8 mg/administration. 9. The method of claim 1, wherein said adult subject is male.

Details for Patent 10,351,615

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	10,351,615	2032-08-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	10,351,615	2032-08-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	10,351,615	2032-08-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	10,351,615	2032-08-02