Hollis-Elden to begin HE2200 trials in USA

Hollis-Eden Pharmaceuticals has received clearance from the US Food andDrug Administration to begin human clinical trials with HE2200, an immune regulating hormone drug candidate, which has been shown to provide significant benefit in a number of animal models of immune dysregulation, possibly by improving defects in cell-mediated (T-helper cell) immunity.

The initial Phase I trial is expected to begin next month and will evaluate the compound in healthy adults and elderly volunteers, with the primary endpoint being safety and tolerance of two dosage levels, with additional objectives of evaluating changes in a number of key immune markers and pharmacokinetic data. Further trials are also planned for several immune dysregulation conditions, including reversal of immune deficiencies seen in the elderly, particularly as this relates to the inability of this group of people to mount an optimal response to vaccines, and hematopoeisis.