Patent Evaluation: CGRP for the Treatment of Undescended Testes

Summary

Novelty: Methods for the treatment of undescended testicles in male animals are described which comprise administration of calcitonin gene-related peptide (CGRP) or an analogue having CGRP activity, optionally in association with a carrier and/or excipient, in an amount effective to cause testicular descent. Pharmaceutical compositions containing CGRP (or an analogue) and methods for their administration (topical, intravenous, subcutaneous) are included in the claim. The use of CGRP in this way is an effective alternative to invasive surgery.

Biology: CGRP activity was assessed quantitatively in vivo using isolated male gubernacum tissue and infant male rodents whose testes have not previously descended. In the first assay, the isolated male gubernacum tissue undergoes rhythmic contractions in the presence of CGRP (or its analogues) and in the second, testicular descent takes place following CGRP (or its analogues) application. No such changes occur in control experiments.

Chemistry: CGRP is produced by automated peptide synthetic techniques or by recombinant DNA methods. Analogues of CGRP containing amino acid sequence variants fall into three classes; substitutional, insertional or deletional variants. Substitutional variants are those in which at least one amino acid residue in the CGRP sequence has been substituted by an alternative.