A development-stage pharmaceutical company based in San Diego, California, Hollis-Eden Pharmaceuticals, announced the preliminary results of an exploratory phase II clinical trial with the company's investigational immune regulating hormone, HE2200, in patients with significant dyslipidemia that could not be corrected by strict dietary control. The study was designed to evaluate the safety of HE2200 as well as the effect of the compound when given bucally once daily for 28 days on a number of lipid parameters. Results of the study indicated that HE2200 was generally well tolerated. When compared to placebo, the compound did not have a statistically significant effect on lipids in the patient population overall in this trial.
"This study, in which a total of 66 patients completed the trial, was designed based on findings from two earlier 30-person placebo controlled Phase I studies which showed that HE2200 reduced cholesterol levels after three days of subcutaneous or five days of buccal dosing in healthy volunteers who were not subject to strict dietary control," stated Dr. James Frincke, chief scientific officer of Hollis-Eden. "While the preliminary results from this exploratory trial in patients with multiple lipid abnormalities do not confirm our earlier cholesterol findings, we continue to believe that this class of compounds has an important potential role to play in metabolic disorders. We are continuing to evaluate the data from this study as well as from preclinical work in this area. We will also be analyzing results from a separate Phase II clinical trial with HE2200 focused on immune enhancement in the elderly, which should be available in the next several months."
"While we will continue to review further analyses and opportunities for HE2200, our top near-term priority clearly remains in the area of radiation and chemotherapy-induced immune suppression with HE2100," stated Richard Hollis, chairman and CEO of Hollis-Eden. "We are making significant progress in these areas and I am pleased to announce that we have been selected to give an oral presentation at the upcoming American Society of Hematology meeting that is taking place in San Diego from December 6-9, 2003, where we will be presenting an update on these programs. We continue to move aggressively to bring HE2100 forward towards commercialization."