A method of warming a vial containing a sterile corticotropin composition from a temperature of 2? to 8? C. to a temperature of 18? to 26? C., withdrawing the sterile corticotropin composition from the vial with a first needle having a first gauge size with a first diameter, replacing the first needle with a second needle having a second gauge size with a second diameter that is different from the first diameter, and injecting 80 (United States Pharmacopeia) USP units of the sterile corticotropin composition into a human subject.

The present invention relates to a CRH formulation having improved stability/efficacy. The improved CRH formulation is particularly suitable for treatment of various disorders. The invention also relates to a method of producing the CRH formulation, and to methods of treatment using said CRH formulation.

The present invention relates to a CRH formulation having improved stability/efficacy. The improved CRH formulation is particularly suitable for treatment of various disorders. The invention also relates to a method of producing the CRH formulation, and to methods of treatment using said CRH formulation.

A sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.

The present disclosure relates to polypeptides (also referred to herein as CXCR4 binding molecules or polypeptides) that are directed against the G-coupled protein receptor CXCR4, also known as Fusin or CD184. The invention also relates to nucleic acids encoding such polypeptides; to methods for preparing such polypeptide; to compositions, and in particular to pharmaceutical compositions that comprise such polypeptides and to uses of such polypeptides for therapeutic or diagnostic purposes.

The present invention provides a compound or a pharmaceutically acceptable salt of the Formula:

X.sub.1IVX.sub.2SLDVPIGLLQILX.sub.3EQEKQEKEKQQAK*TNAX.sub.4ILAQV-NH.sub.2 wherein the X.sub.1 denotes that the I residue is modified by either acetylation or methylation at the N-terminus; wherein X.sub.2 is L or T; wherein X.sub.3 is L or I; wherein X.sub.4 is Q or E; and wherein a modified K residue (K*) at position 29 is modified through conjugation to the epsilon-amino group of the K-side chain with a group of the formula X.sub.5X.sub.6, wherein X.sub.5 is selected from the group consisting of one to four amino acids; one to four ([2-(2-Amino-ethoxy)-ethoxy]-acetyl) moieties; and combinations of one to four amino acids and one to four ([2-(2-Amino-ethoxy)-ethoxy]-acetyl) moieties; and X.sub.6 is a C.sub.14-C.sub.24 fatty acid. In some embodiments, the group of the formula X.sub.5X.sub.6 is ([2-(2-Amino-ethoxy)-ethoxy]-acetyl).sub.2-(E).sub.2-CO(CH.sub.2).sub.xCO.sub.2H where x is 16 or 18.

In alternative embodiments, provided are methods for treating, ameliorating or protecting (preventing) congestive heart failure (CHF) or a diabetes-related cardiac dysfunction, comprising: providing a urocortin 2-encoding and/or a urocortin 3-encoding nucleic acid, transcript or message, or gene, operatively linked to a transcriptional regulatory sequence, optionally contained in an expression vehicle or a vector such as an adeno-associated virus (AAV), e.g., an AAV8 serotype; and administering to an individual or a patient in need thereof, such as a type 2 diabetic (T2DM), e.g., by IV administration, thereby treating, ameliorating or protecting against (preventing) the T2DM and/or the diabetes-related cardiac dysfunction in the individual or patient.

Methods for treating or preventing tauopathies and/or A amyloidosis by modulating CRF receptor signaling. Accumulation of hyperphosphorlyated tau protein in the CNS may be reduced by administration of CRF-R1 selective antagonists and/or CRF-R2 selective agonists. For example, in some aspects, methods for preventing the onset of Alzheimer's disease by administration of CRF-R1 selective antagonist are provided.

Methods, compositions, uses and kits can be provided to treat cancer in a subject, which can include administering to the subject an active agent to induce enhanced tumor cell mitosis, and providing, in proximity or immediately after that, a therapy that specifically targets cells in mitosis, such as chemotherapy or radiation.

Methods, compositions, uses and kits can be provided to treat cancer in a subject, which can include administering to the subject an active agent to induce enhanced tumor cell mitosis, and providing, in proximity or immediately after that, a therapy that specifically targets cells in mitosis, such as chemotherapy or radiation.