A ghrelin agonist in Cancer Anorexia/Cachexia (CACS) Syndrome.

• Two functions of ghrelin which support the rationale for the development in CACS:
  • appetite enhancement
  • gain in body weight (in particular in lean body mass) mediated by the growth hormone.
• Anamorelin carries out the functions of ghrelin but associated with a favorable pharmacokinetics (much longer half-life).
• Oral formulation (tablets) available in a preliminary form and already used in clinical studies
• IND opened in 2003 and fast track designation obtained from FDA in 2004.
• 9 Phase I studies and 3 Phase IIa studies completed. 1 Phase IIb study currently on-going.
• Good safety profile and promising efficacy results
• Encouraging meeting with FDA in June.
• Positive decision of the "Cancer Cachexia Data Monitoring" commission after the interim analysis of the Phase II study.