The State University of New York

Robert M Straubinger

Marc Besman

Ramesh Kashi

Sathy V Balu-Iyer

Sathyamangalam V Balasubramanian

Razvan D Miclea

Karthik Ramani

Aaron Peng

Vivek S Purohit

Eric Mayhew

Amarnath Sharma

Razvan Michlea

Razvan Miclea

The present invention provides compositions and methods for reducing the immunogenicity and increasing the circulating half-life of therapeutic proteins such as Factor VIII. The compositions comprise lipidic structures such as liposomes, micelles and cochleates comprising a negatively charged lipid and polyethylene glycol derivatized phosphatidyl ethanolamine.

Compositions and methods for less immunogenic protein-lipid complexes

Provided are lipidic particles comprising phosphatidylcholine, phosphatidylinositol and cholesterol. Also provided are compositions comprising the lipidic particles and having associated therewith therapeutic agents such as peptides, polypeptides or proteins. In these compositions, the therapeutic agents have reduced immunogenicity and/or longer circulating time. These compositions can be used for therapeutic administration of the peptides, polypeptides and/or proteins.

Compositions of less immunogenic and long-circulating protein-lipid complexes

Provided is a method for treatment of blood coagulation disorders. The method comprises administering to an individual compositions comprising lipidic particles comprising phosphatidylcholine, phosphatidylinositol and cholesterol. One or more peptides, polypeptides or proteins involved in the blood coagulation cascade are associated with the lipidic particles.

Method for treating blood coagulation disorders

The present invention relates to methods for complexing a protein in a dispersed medium. Also disclosed are associated proteins produced by the methods of complexing of the present invention. Pharmaceutically effective stabilized protein dosages are also disclosed. The present invention also relates to a method for associating AHF protein in a dispersed medium.

Method of complexing a protein by the use of a dispersed system and proteins thereof

Methods and composition are described for low immunogenic protein, polypeptide or peptide formulations. The method comprises forming complexes of the protein, polypeptide or peptide with a binding agent which can be a serine containing compound or other phosphatidyl compounds or phospholipids. The complexes formed include simple complexes, micelles, cochleate structures, liposomes, non-bilayer and novel lipidic structures. The antigenicity and imminogenicity of the protein, polypeptides or peptides is reduced upon formation of such complexes.

Compositions and methods for less immunogenic protein formulations

The invention provides a method of stabilizing a taxane in a dispersed system, which method comprises exposing the taxane to a molecule which improves physical stability of the taxane in the dispersed system. By improving physical stability of the taxane in the dispersed system, higher taxane content can be achieved. The invention thus further provides a stable taxane-containing liposome preparation comprising a liposome containing one or more taxanes present in the liposome in an amount of less than 20 mol % total taxane to liposome, wherein the liposome is suspended in a glycerol:water composition having at least 30% glycerol.

Stabilization of taxane-containing dispersed systems

The present invention relates to a pharmaceutical composition for use in treatment of cancer patients. The composition includes at least one taxane present in a pharmaceutical effective amount and a mixture of one or more negatively charged phospholipids and one or more zwitterion (i.e. uncharged) phospholipids. This mixture entraps the at least one taxane in what is believed to be a liposome. The mixture contains a ratio of negatively charged phospholipids to zwitterion phospholipids of 1:9 to 7:3. The taxol is present in an amount of 1.5-8.0 mole percent taxane. The composition is in the form of particles having a size of 0.025 to 10 microns with substantially no taxane crystals.

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Amherst, NY, United States of America

Robert M Straubinger