Endocrine Therapy

Diagnostic test for growth hormone deficiencies

Phase 3

Solorel^TM (AEZS-130), a growth hormone secretagogue (GHS), is a novel synthetic small molecule, acting as a ghrelin mimetic, that is orally active and stimulates the secretion of growth hormone (GH).  In addition to the diagnostic indication, Solorel^TM(AEZS-130), based on results of Phase 1 studies, has potential applications for the treatment of cachexia, a condition frequently associated with severe chronic diseases such as cancer, chronic obstructive pulmonary disease and AIDS.

Growth hormone secretagogues (GHS) are a potent regulator of lipid, sugar and protein metabolism, that directly stimulate growth hormone (GH) secretion from the pituitary gland without the involvement of Growth Hormone Releasing Hormone (GH-RH) or somatostatin.

The poster #P2-749 entitled, "Use of an oral GHS ghrelin-mimetic GHS as a simple diagnostic test for adult GH deficiency", G.R. Merriam, K.C.J. Yuen, P. Asberry, .V Bonert, A. Dobs, J.M. Garcia, M. Kipnes, M. Kletke, M. Molitch, R. Swerdloff, C. Wang, D. Cook and B.M.K. Biller, presents the first clinical data relating to the use of Solorel^TM(AEZS-130) as a simple diagnostic test for adult growth hormone deficiency. Data showed that in adult growth hormone deficient patients, the responses to the orally administered Solorel^TM(AEZS-130) compound were comparable to currently validated agents and cleanly separated patients from normal control subjects.

The poster was presented at the annual meeting of the Endocrine Society on Thursday, June 11, 2009.

A pivotal Phase 3 trial was initiated in the US to investigate the safety and efficacy of Solorel^TM (AEZS-130) as a GH stimulation test for the diagnosis of GH deficiency in adults (AGHD) for which Orphan Drug status had been granted by the FDA in 2007. As we regained this compound from a former partner, we expect to reactivate the Phase 3 study for the diagnosis of AGHD in the second half of 2010.