BioMedTec Normal client4 2 2004-01-07T08:29:00Z 2004-01-30T12:44:00Z 2004-01-30T12:44:00Z 1 271 1682 27 2 2034 9.2812

Immune Regulating Steroid Hormones.

Chris Reading, Hollis Eden Pharmaceuticals, Inc., 92121 San Diego, CA, USA

e-mail: creading@holliseden.com

Immune regulating hormones (IRH) are anti-inflammatory, immune modulating steroids, devoid of immune suppressive or androgenic side effects. IRH show benefit in models of infectious, metabolic, neoplastic and autoimmune diseases. IRH increase Th1 and limit Th2 responses. Differences relate to orientation and functionality at specific points on the steroid ring. One synthetic IRH, HE2000 (16 a epi-androsterone) shows dramatic benefit as immune therapy for patients with HIV/AIDS. Benefits include significant reductions in viral loads, frequencies of opportunistic infections (especially TB), levels of pro-inflammatory cytokines (TNF-a, IL-1b, IL-6, IL-8) and increased markers of protective immunity (HIV specific CD8+ CTL, CD123+ DC). HE2000 improves innate immunity, and clears parasites in patients infected with P. falciparum malaria. Benefits depend on anti-inflammatory and immune modulating capacity. HE2000 (0.1-10 uM) dose-dependently prevents LPS induced NO production by 24 hr cultures of RAW 264.7 cells. Treatment with HE2000, 24 hr and 1 hr before challenge, limits (>50%) numbers of neutrophils and exudate volumes in the carageenan-induced pleurisy model of acute inflammation. In the popliteal lymph node assay, HE2000 significantly increased CD8+ T cells, DC, and IFN-g, but not IL-4, producing cells. Certain metabolites of HE2000 show increased (10X) potency in in vitro and in vivo models of acute inflammation and infectious disease. Another natural IRH, HE2100 (3b, 17b-androstenediol) restores innate immune responsesafter radiation and chemotherapy to protect against lethal sepsis. IRH represent a novel approach to immune therapy, simultaneously limiting inflammation and restoring protective immune responses. With an understanding of metabolism and structure function relationships, IRH have the potential to address some of the most challenging and unmet medical needs of our time.