Initial Phase I Clinical Study With HE2200 Completed.(Brief Article)

2001 DEC 19 - (NewsRx.com & NewsRx.net) -- Hollis-Eden Pharmaceuticals, Inc., (HEPH) announced it has completed a Phase I clinical study with subcutaneously administered HE2200, an immune-regulating hormone drug candidate, in healthy young and elderly adult volunteers.

HE2200 was generally well tolerated by patients in the Phase I study. Hollis-Eden also received clearance from the United States Food and Drug Administration (FDA) to begin a similar Phase I human clinical trial with HE2200 using a buccal tablet formulation.

Preclinical studies with HE2200 have indicated the compound has the potential to provide benefit in a variety of settings of immune dysregulation including inflammatory bowel disease, age-related loss of immunity and radiation-induced immune suppression. Hollis-Eden plans to conduct U.S. Phase II clinical studies related to one or more of these areas.

Hollis-Eden and its collaborators have made a series of presentations at medical meetings demonstrating the broad-spectrum activities of HE2200 in a number of different preclinical models. In November 2001, Hollis-Eden scientists presented data at the Cytokine Odyssey 2001 meeting indicating HE2200 was very effective in a model of inflammatory bowel disease. In this experiment HE2200 was compared with sulfasalazine, a standard of care in inflammatory bowel disease.

The results indicated HE2200 was superior to sulfasalazine in controlling inflammation and ulcerations and also in reducing the incidence of diarrhea. In addition the Company presented data at this meeting indicating HE2200 produced significant bone sparing effects in a well-accepted bone loss model.

HE2200 has also been shown in preclinical studies to improve defects in cell-mediated (Th1) immunity. Deficiency of cell-mediated immunity has been strongly correlated with an immune system's inability to effectively fight a number of infectious diseases and cancer types. A progressive loss of the ability to mount a strong cell-mediated immune response is seen in the elderly and is believed to be a primary reason why patients in this age group have difficulty recovering from infectious diseases such as the flu and pneumonia and is also believed to be why vaccines in this population tend to be less effective.

Results presented in April 2001 at the 4th Annual Conference on Vaccine Research reported that administration of hepatitis B vaccine to young ...