# US 8,771,663 B2 · Formulation having mobilising activity

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 8,771,663 B2
- Document ID: US8771663B2
- Status: Granted
- Kind: B2
- Application number: 12/755,321
- Filed: 2010-04-06
- Published: 2010-10-07
- Granted: 2014-07-08
- Earliest claimed: 2000-04-18
- Assignees: Gentium S.R.L.
- Applicants: Laura Ferro; Roberto Porta; Massimo Iacobelli; Massimo Alessandro Gianni; Carmelo Carlo Stella
- Inventors: Laura Ferro; Roberto Porta; Massimo Iacobelli; Massimo Alessandro Gianni; Carmelo Carlo Stella
- Web page: https://patentgrep.com/patent/US8771663B2

## CPC

- A61K 31/7088: Compounds having three or more nucleosides or nucleotides
- A61K 31/711: Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
- A61K 38/18: Growth factors; Growth regulators
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 38/2053: {IL-8}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- 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 innovation relates to a novel formulation capable of increasing the amount of stem cells and progenitor cells in circulation in the peripheral blood of a mammal; the formulation is characterized in that it contains defibrotide in combination with at least one haematopoietic factor having the capacity to mobilize haematopoietic progenitors, preferably G-CSF. In one embodiment, the formulation includes two separately administrable formulations, one containing a haematopoietic factor having the capacity to mobilize haematopoietic progenitors and the other containing defibrotide. The formulation is effective to achieve an increase in the number of haematopoietic progenitor cells that is greater than an increase in the number of haematopoietic progenitor cells achieved by the haematopoietic factor alone.

## Claims

### Claim 1

A formulation comprising a haematopoietic factor having the capacity to mobilize haematopoietic progenitors and defibrotide as described in Chemical Abstract Registry No. 83712-60-1, wherein said formulation is effective to achieve an increase in the number of haematopoietic progenitor cells that is greater than an increase in the number of haematopoietic progenitor cells achieved by the haematopoietic factor alone.

### Claim 2 (depends on 1)

The formulation according to claim 1, characterized in that the haematopoietic factor having the capacity to mobilize haematopoietic progenitors is G-CSF.

### Claim 3 (depends on 1)

The formulation according to claim 1, characterized in that it is an aqueous solution.

### Claim 4 (depends on 1)

The formulation according to claim 1 further comprising an excipient or a coadjuvant.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein defibrotide is in the form of a salt of an alkali metal.

### Claim 6 (depends on 1)

The formulation of claim 1, wherein said alkali metal is sodium.

### Claim 7

A formulation comprising defibrotide as characterized by Chemical Abstract Registry No. 83712-60-1 and at least one haematopoietic factor having the capacity to mobilize haematopoietic progenitors, as a combined preparation,
wherein said formulation is effective to increase the number of haematopoietic progenitor cells relative to the increase in the number of haematopoietic progenitor cells achieved by the haematopoietic factor alone.

### Claim 8 (depends on 7)

The formulation of claim 7, wherein defibrotide is in the form of a salt of an alkali metal.

### Claim 9 (depends on 7)

The formulation of claim 7, wherein said alkali metal is sodium.

### Claim 10 (depends on 7)

The formulation of claim 7, wherein the haematopoietic factor having the capacity to mobilize haematopoietic progenitors is G-CSF.

### Claim 11 (depends on 1)

A method of increasing the amount of stem cells and/or haematopoietic progenitors in the peripheral blood of a mammal comprising administering to the mammal the formulation according to claim 1;
wherein administration of said formulation results in an increase in the number of haematopoietic progenitor cells that is greater than the increase in the number of haematopoietic progenitor cells achieved by administration of the haematopoietic factor alone.