An improved method for producing human growth hormone (hGH) in vitro or in vivo. This invention can be applied to a non-invasive method of gene therapy to achieve sustained delivery of this therapeutic protein.

This invention described and claimed in this patent application provides for an improved method for producing human growth hormone (hGH) in vitro or in vivo. In particular, the patent application describes compositions and methods which are based on a modified form of human growth hormone where the regulated secretory pathway (RSP) sorting signal has been modified to provide for the constitutive secretion of human growth hormone via the nonregulated secretory pathway (NRSP) in a mammalian cell. One particular modified hGH composition, has been demonstrated to be biologically active and able to be secreted into the bloodstream in an animal model providing proof-of-concept. This invention can be applied to a non-invasive method of gene therapy to achieve sustained delivery of this therapeutic protein. This work has been published in J Wang et al., "Partial redirection of transgenic human growth hormone secretion from rat salivary glands," Human Gene Therapy 16(5):571-583 (May 2005).

U.S. Patent Application No. 10/477,651 filed 14 Nov 2003 (HHS Reference No. E-184-2001/1-US-02), which is a 371 application of PCT/US02/15172 filed 14 May 2002 and which claims priority to 60/290,836 filed 14 May 2001. The application has been published as WO 02/092619 (11/21/2002) and as 2004/0158046 A1 (08/12/2004). Only U.S. patent protection has been sought for this technology. There are no foreign counterpart patent applications. Inventors: YP Loh, NX Cawley (both of NICHD), BJ Baum (NIDCR), and CR Snell

Licensees sought. This technology is available for non- exclusive and exclusive licensing. Collaborative Research Opportunity: The NICHD Office of the Scientific Director is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the non-invasive method of production and systemic delivery of growth hormone or other proteins for therapeutic purposes. Please contact Dr. Y. Peng Loh at 301/496-3239 or lohp@mail.nih.gov for more information.