Abstract: The present invention relates to a method for preventing, treating, or ameliorating arterial restenosis after angioplasty in an animal by administering to the animal active vitamin D compounds. The invention further relates to a method for preventing, treating, or ameliorating restenosis after angioplasty in an animal by administering to the animal active vitamin D compounds in combination with other therapeutic agents. A further aspect of the invention is a method for preventing, treating, or ameliorating stenosis within and/or around an arterial bypass graft in an animal comprising administering to the animal an active vitamin D compound.

Abstract: The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit dose composition comprising 0.2 ?g/kg to 48 ?g/kg of an FGF-2 of SEQ ID NO: 2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. In another aspect, the present invention is directed to a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of a human patient in need of treatment for coronary artery disease a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. The single unit dose composition of the present invention provides an angiogenic effect in a human CAD patient that lasts 2 months before re-treatment is required. In another aspect, the present invention is directed to a method of administration which optimizes patient's safety.

Abstract: The present invention relates to a method for preventing, treating, or ameliorating arterial restenosis after angioplasty in an animal by administering to the animal active vitamin D compounds. The invention further relates to a method for preventing, treating, or ameliorating restenosis after angioplasty in an animal by administering to the animal active vitamin D compounds in combination with other therapeutic agents. A further aspect of the invention is a method for preventing, treating, or ameliorating stenosis within and/or around an arterial bypass graft in an animal comprising administering to the animal an active vitamin D compound.

Abstract: Compositions and methods for treating peripheral artery disease in a patient are provided. Compositions comprise recombinant fibroblast growth factor-2. Fibroblast growth factor, such as FGF-2, is administered in therapeutically effective amounts to treat or prevent peripheral artery disease including claudication and critical limb ischemia. Pharmaceutical compositions comprising a therapeutically effective amount of FGF-2 and a pharmaceutically acceptable carrier are also provided. The methods of the invention to treat peripheral artery disease and claudication comprise administering at least a single dose of a pharmaceutical composition comprising the FGF, such as FGF-2, via intra-arterial, intravenous, or intramuscular infusion to the patient. It is recognized that increased benefits may result from multiple dosing, including intermittent dosing.

Abstract: Methods of treating MDS, or ameliorating a symptom thereof, are disclosed. Specific methods encompass the administration of one or more vitamin D compounds, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with one or more additional active agents. Other methods include intermittent administration of a high dose of one or more vitamin D compounds, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with one or more additional active agents. Such intermittent administration allows high doses of the vitamin D compounds to be administered while minimizing or eliminating hypercalcemia.

Abstract: Disclosed are pharmaceutical compositions comprising an active vitamin D compound in emulsion pre-concentrate formulations, as well as emulsions and sub-micron droplet emulsions produced therefrom. The compositions comprise a lipophilic phase component, one or more surfactants, and an active vitamin D compound. The compositions may optionally further comprise a hydrophilic phase component.

Abstract: The present invention relates to a method for treating, ameliorating, or preventing immune-mediated disorders in an animal by administering to the animal active vitamin D compounds or mimics thereof The invention further relates to a method for treating, ameliorating, or preventing immune-mediated disorders in an animal by administering to the animal active vitamin D compounds or mimics thereof in combination with other therapeutic agents.

Abstract: The present invention relates to a method for treating or ameliorating lung cancer in an animal by administering to the animal active vitamin D compounds or mimics thereof by high dose pulse administration in combination with one or more chemotherapeutic agents or radiotherapeutic agents/treatments.

Abstract: The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit dose comprising 0.2 ?g/kg to 36 ?g/kg of a recombinant FGF or an angiogenically active fragment or mutein thereof. In another aspect, the present invention is directed to a pharmaceutical composition comprising an angiogenically effective dose of an FGF or an angiogenically active fragment or mutein thereof, and a pharmaceutically acceptable carrier. Typically, the angiogenically effective dose comprises 0.2 ?g/kg to 36 ?g/kg of an FGF of any one of SEQ ID NOS:1-3, 5, 8-10, or 12-14 or an angiogenically active fragment or mutein thereof.

Abstract: The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit dose composition comprising 0.2 ?g/kg to 48 ?g/kg of an FGF-2 of SEQ ID NO: 2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. In another aspect, the present invention is directed to a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of a human patient in need of treatment for coronary artery disease a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. The single unit dose composition of the present invention provides an angiogenic effect in a human CAD patient that lasts 2 months before re-treatment is required. In another aspect, the present invention is directed to a method of administration which optimizes patient's safety.

Abstract: Methods of treating MDS, or ameliorating a symptom thereof, are disclosed. Specific methods encompass the administration of one or more vitamin D compounds, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with one or more additional active agents. Other methods include intermittent administration of a high dose of one or more vitamin D compounds, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with one or more additional active agents. Such intermittent administration allows high doses of the vitamin D compounds to be administered while minimizing or eliminating hypercalcemia.

Abstract: Disclosed are pharmaceutical compositions comprising an active vitamin D compound in emulsion pre-concentrate formulations, as well as emulsions and sub-micron droplet emulsions produced therefrom. The compositions comprise a lipophilic phase component, one or more surfactants, and an active vitamin D compound. The compositions may optionally further comprise a hydrophilic phase component.