Alkermes Controlled Therapeutics, Inc. Ii

Stolle Research & Development Corporation

Southern Research Institute

Richards Medical Company

Clsn Laboratories, Inc.

The United States of America As Represented by the Secretary of

Egen, Inc.

Antriabio, Inc.

Syntex (u.s.a.) Inc.

Alkermes Controlled Therapeutics, Inc.

Janssen Pharmaceutica

Repromed, Inc.

Pr Pharmaceuticals, Inc.

Danny H Lewis

J Michael Ramstack

Michael E Rickey

Khursheed Anwer

Jason Fewell

Majed Matar

Richard L Dunn

Thomas R Tice

Paul J Schmidt

Thomas W Sander

Kenneth Hinds

Jennifer Rice

James A Davidson

Lee R Beck

Donald R Cowsar

Neil B Beals

Clifford S Lofgren

David F Williams

Kathleen M Campbell

Yancy L Gill

Robert K Meer

William E Meyers

Jean Louis Mesens

Richard W Treharne

John S Kent

Lynda M Sanders

William E Myers

Leonard E Laufe

Jason G Fewell

Compositions, methods, and applications that increase the efficiency of nucleic acid transfection are provided. In one aspect, a pharmaceutical composition may include at least about 0.5 mg/ml concentration of a nucleic acid condensed with a cationic lipopolymer suspended in an isotonic solution, where the cationic lipopolymer includes a cationic polymer backbone having cholesterol and polyethylene glycol covalently attached thereto, and wherein the molar ratio of cholesterol to cationic polymer backbone is within a range of from about 0.1 to about 10, and the molar ratio of polyethylene glycol to cationic polymer backbone is within a range of from about 0.1 to about 10. The composition further may include a filler excipient.

Nucleic acid-lipopolymer compositions

The invention is directed to a single-step method for rapidly and efficiently preparing protein-polymer conjugates, including an insulin-polymer conjugate. According to the method of the present invention, a protein and hydrophilic polymer are contacted in the presence of at least one organic solvent and at least one metal chelator, under conditions that promote the formation of a conjugate of the protein and polymer. Thus, the invention is directed to the site-specific modification of selected proteins, such as insulin, with poly(ethylene glycol) at residue PheB1. The invention also provides a pharmaceutical formulation for encapsulating the conjugate in a biodegradable polymer.

Site-specific insulin-polymer conjugates

Pharmaceutical compositions comprising a nucleic acid, a gene delivery polymer, and at least one adjunctive chemotherapeutic drug for the treatment of mammalian cancer or hyperproliferative disorders and methods of using thereof for the treatment of mammalian cancer or hyperproliferative disorders by intratumoral, intraperitoneal or systemic injection.

Immuno gene therapy for treatment of cancer and hyperproliferative diseases

Materials and methods for preparing protein-polymer conjugates

Combination of immuno gene therapy and chemotherapy for treatment of cancer and hyperproliferative diseases

Formulations for controlled, prolonged release of bioactive molecules such as therapeutic proteins, peptides and oligonucleotides have been developed. These formulations are based on solid microparticles or nanoparticles formed of the combination of biodegradable, synthetic polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and copolymers thereof. Bioactive molecules are coupled to hydrophilic polymers such as polyethylene glycol or polypropylene glycol and formulated to provide controlled release. The bioactive molecules are more stable, less immunogenic and have improved release rate profiles with lower burst levels and increased drug loading relative to the same bioactive molecules lacking coupled hydrophilic polymers. The controlled release formulations can be administered by injection, by inhalation, nasally, or orally.

Methods and compositions for enhanced delivery of bioactive molecules

A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymer, an active agent, and a solvent. A second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The discontinuous first phase is separated from the continuous second phase. The residual level of solvent in the discontinuous first phase is reduced to less than about 2% by weight.

Preparation of biodegradable, biocompatible microparticles containing a biologically active agent

A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymer, an active agent, and a solvent. An immiscible second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are immersed in a quench liquid that includes a quench medium and a quantity of the solvent. The quantity of the solvent is selected to control a rate of extraction of the solvent from the first phase. The first phase is isolated in the form of microparticles. Also disclosed is a microencapsulated active agent prepared by the method for preparing biodegradable, biocompatible microparticles.

Preparation of biodegradable, biocompatible microparticles containing a

A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymeric encapsulating binder, and an active agent having limited water solubility dissolved or dispersed in a solvent. An aqueous second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are separated. The discontinuous first phase is washed with water, or an aqueous solution of water and a solvent for residual solvent in the first phase, to reduce the level of residual solvent in the microparticles to less than about 2% by weight of the microparticles. Also disclosed are a microencapsulated drug prepared by the method for preparing biodegradable, biocompatible microparticles, and a pharmaceutical composition that includes biodegradable and biocompatible microparticles in a pharmaceutically acceptable carrier.

Preparation of extended shelf-life biodegradable, biocompatible

A delivery system for providing antiparasitic agents to animals is provided and a method of treating parasitic infections in animals using such delivery systems is described. The delivery system is particularly useful for treatment with avermectins and milbemycins in lactide/glycolide polymeric matrices.

Controlled release of antiparasitic agents in animals

A delivery system for providing growth promoters to food animals is provided and a method of promoting growth in food animals using such delivery systems is described.

Growth promoters for animals

Growing community of inventors

Hartselle, AL, United States of America

Danny H Lewis