# US 9,433,664 B2 · Factor II and fibrinogen for treatment of haemostatic disorders

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- Number: US 9,433,664 B2
- Document ID: US9433664B2
- Status: Granted
- Kind: B2
- Application number: 13/877,854
- Filed: 2011-09-19
- Published: 2013-10-24
- Granted: 2016-09-06
- Earliest claimed: 2010-10-06
- Assignees: MedImmune, LLC
- Applicants: Ann Lovgren; Kenny Hansson
- Inventors: Ann Lovgren; Kenny Hansson
- Web page: https://patentgrep.com/patent/US9433664B2

## CPC

- A61K 38/4833: {Thrombin (3.4.21.5)}
- A61K 38/363: {Fibrinogen}
- A61K 38/4846: {Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to normalizing impaired haemostasis comprising administering a clotting factor treatment selected from the group consisting of (1) FII; (2) PCC; and (3) a three factor combination of FH, FX and FVIIa. The clotting factor treatment can be administered in combination with fibrinogen. The clotting factor(s) can be recombinant human clotting factor(s).

## Claims

### Claim 1

A method of normalizing impaired haemostasis associated with dilutional coagulopathy in a mammal in need thereof comprising administering a clotting factor treatment selected from the group consisting of: (1) recombinant human FII (rhFII), (2) a combination of rhFII and recombinant human FVIIa (rhVIIa), (3) a combination of rhFII, rhVIIa, and recombinant human FX (rhFX), (4) fibrinogen and a combination of rhFII, rhFVIIa, and rhFX, (5) fibrinogen and rhFII, and (6) fibrinogen and a combination of rhFII and rhVIIa,
wherein administration of said clotting factor treatment is performed without co-administration of any other coagulation factors selected from human coagulation factors FV-FXIII.

### Claim 2 (depends on 1)

The method of claim 1, wherein said impaired haemostasis associated with dilutional coagulopathy is associated with massive blood loss or a traumatic bleeding event.

### Claim 3 (depends on 2)

The method of claim 2, wherein said hemorrhage or traumatic bleeding event is associated with peri-surgical bleeding, post-surgical bleeding or postpartum hemorrhage.

### Claim 4 (depends on 1)

The method of claim 1, wherein the mammal in need of treatment has a blood fibrinogen concentration level of less than 2 g/L, less than 1 g/L, less than 0.5 g/L, less than 200 mg/dL, less than 150 mg/dL, less than 100 mg/dL, or less than 50 mg/dL g/L.

### Claim 5 (depends on 1)

The method of claim 1, wherein said dilutional coagulopathy is associated with a blood loss of greater than 30%, greater than 40%, greater than 50%, greater than 60%, greater than 70%, greater than 80% or greater than 85% of the estimated total blood volume of a mammal.

### Claim 6 (depends on 1)

The method of claim 1, wherein said dilutional coagulopathy results from reestablishment of normovolemia or haemodynamic stabilization.

### Claim 7 (depends on 1)

The method of claim 1, wherein fibrinogen is administered in an amount sufficient to raise the blood fibrinogen concentration above 0.5 g/L, above 1 g/L, above 1.5 g/L, or above 2 mg/L.

### Claim 8 (depends on 1)

The method of claim 1, wherein fibrinogen is administered at a dose of 12.5 to 200 mg/kg.

### Claim 9 (depends on 1)

The method of claim 1, wherein the clotting factor is rhFII and is administered at a dose of 1 to 10 mg/kg.

### Claim 10 (depends on 1)

The method of claim 1, wherein the clotting factor treatment is administered at a dose that reduces clotting time by 40 seconds to 60 seconds.

### Claim 11 (depends on 1)

The method of claim 1, wherein the clotting factor treatment is administered at a dose that increases maximum clot firmness to 10 mm to 30 mm.

### Claim 12 (depends on 1)

The method of claim 1, wherein administration of said clotting factor treatment results in the maintenance of normalized coagulation for at least two hours after administration.

### Claim 13

A method of normalizing impaired haemostasis associated with dilutional coagulopathy in a mammal in need thereof, the method comprising administering a clotting factor treatment selected from the group consisting of: (1) recombinant human FII (rhFII), and (2) fibrinogen and rhFII; wherein fibrinogen is administered at a dose of 12.5 to 200 mg/kg, rhFII is administered at a dose of 1 to 10 mg/kg and administration of said clotting factor treatment is performed without co-administration of any other coagulation factors from among the human coagulation factors FV-FXIII.

### Claim 14 (depends on 13)

The method of claim 13, wherein fibrinogen is administered in an amount sufficient to raise the blood fibrinogen concentration above 0.5 g/L, above 1 g/L, above 1.5 g/L, or above 2 mg/L.

### Claim 15 (depends on 13)

The method of claim 13, wherein the mammal in need of treatment has a blood fibrinogen concentration level of less than 2 g/L, less than 1 g/L, less than 0.5 g/L, less than 200 mg/dL, less than 150 mg/dL, less than 100 mg/dL, or less than 50 mg/dL g/L.

### Claim 16 (depends on 13)

The method of claim 13, wherein said dilutional coagulopathy is associated with a blood loss of greater than 30%, greater than 40%, greater than 50%, greater than 60%, greater than 70%, greater than 80% or greater than 85% of the estimated total blood volume of a mammal.