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Lupus Clinical Trials

New Medical Therapies™

Metabolic Syndrome

October 4, 2004

LAB International has announced positive results of a phase I/II trial of their Growth Hormone Releasing Hormone (GHRH) analog, being developed as an inhalable treatment for growth hormone (GH) deficiency caused by a number of diseases, including HIV, chronic renal failure and lipodystrophy. The drug was found to be safe and well tolerated, with no significant adverse events. Furthermore, the drug produced significant increases in serum GH levels up to 12 hours after treatment at all dosing regimens, and demonstrated a higher-than-expected efficacy for this endpoint. No impact on normal nocturnal GH secretion was observed. The placebo-controlled, single-dose safety and efficacy cross-over study enrolled a total of 10 healthy volunteers, all of whom received randomized sequential dosing regimens of 5-25 ug/kg and placebo. LAB announced plans for both indication-driven phase II trials and another phase I/II dose-ranging trial to establish minimum therapeutic dose.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.