Claims for Patent: 8,623,354

Summary for Patent: 8,623,354

Title:	Therapeutic compositions comprising hyaluronan and therapeutic antibodies as well as methods of treatment
Abstract:	The present invention relates generally to treatment and prophylactic protocols for cellular diseases or disorders, such as diseases and disorders associated with abnormal cellular proliferation. More particularly, the present invention provides compositions comprising therapeutic antibodies and hyaluronan and their use in the treatment or prophylaxis of cellular diseases and disorders.
Inventor(s):	Brown; Tracey J. (Flemington, AU), Brownlee; Gary R. (East Burwood, AU)
Assignee:	Alchemia Oncology Pty Limited (Eight Mile Plains, AU)
Application Number:	12/065,945
Patent Claims:	1. A formulation comprising hyaluronan (HA), or salt thereof, wherein the hyaluronan is in the molecular weight range of about 800 kDaltons to 900 kDaltons, and a therapeutic antibody selected from the group of antibodies consisting of: Bevacizumab; Cetuximab and Rituximab, or antigen-binding portion thereof and, optionally, one or more, pharmaceutically acceptable carriers, diluents and/or excipients, and wherein the hyaluronan or synthesized form thereof and the therapeutic antibody are not covalently bound; and wherein said formulation does not comprise a non-antibody chemotherapeutic agent. 2. The formulation of claim 1, wherein the hyaluronan has a modal molecular weight of 860 kDaltons. 3. The formulation of claim 1, wherein the pH range of the composition is between pH 2.5 and 10.5. 4. The formulation of claim 1, wherein the pH range of the composition is between pH 5.0 and 8.5. 5. The formulation of claim 1, wherein the therapeutic antibody is cetuximab. 6. The formulation of claim 1, wherein the therapeutic antibody is bevacizumab. 7. The formulation of claim 1, wherein the therapeutic antibody is humanised. 8. The formulation of claim 1, wherein the composition is in parenteral form. 9. The formulation of claim 8, wherein the parenteral form is formulated for subcutaneous injection, intravenous, intramuscular, intrathecal, intracranial, intrasternal injection or infusion techniques. 10. The formulation of claim 1, wherein the HA is administered in an amount of about 0.01 to about 40 mg/kg of body weight. 11. The formulation of claim 1, wherein the HA is administered in an amount of about 0.1 to about 27 mg/kg of body weight. 12. A formulation comprising an aqueous suspension of hyaluronan (HA), or salt thereof, wherein the hyaluronan is in the molecular weight range of about 800 kDaltons to 900 kDaltons, in admixture with a therapeutic antibody selected from the group of antibodies consisting of: Bevacizumab; Cetuximab and Rituximab, or antigen-binding portion thereof and one or more, pharmaceutically acceptable carriers, diluents and/or excipients; wherein said formulation does not comprise a non-antibody chemotherapeutic agent. 13. The formulation of claim 12, wherein the hyaluronan has a modal molecular weight range of 860 kDaltons. 14. The formulation of claim 12, wherein the therapeutic antibody is cetuximab.

Details for Patent 8,623,354

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2025-09-07
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2025-09-07
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2025-09-07
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2025-09-07
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2025-09-07