Hollis-Eden Receives FDA Clearance to Initiate Human Clinical Studies With HE2200
SAN DIEGO, Jun 29, 2001 /PRNewswire via COMTEX/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH chart, msgs) today announced it received clearance this week from the United States Food and Drug Administration (FDA) to begin human clinical trials with HE2200, an immune regulating hormone (IRH) drug candidate. HE2200, which has been shown to provide significant benefit in a number of animal models of immune dysregulation, was among the compounds licensed to Hollis-Eden from Roger Loria Ph.D., a leading researcher in the field of IRHs and a Professor of Microbiology and Immunology at Virginia Commonwealth University.
The initial Phase I clinical trial, which is expected to be initiated in July, will study HE2200 in healthy adults and healthy elderly volunteers, with the primary endpoint being safety and tolerance of two dosage levels. Additional objectives of the trial will be to evaluate changes in a number of key immune markers and pharmacokinetic data in both groups of volunteers. The Phase I study will be randomized, double blinded, and placebo-controlled. Following successful completion of the Phase I study, the Company expects to commence Phase II studies with the compound in several conditions of immune dysregulation, including reversal of immune deficiencies seen in the elderly, particularly as it relates to the inability of the elderly to mount an optimal response to vaccines. The Company also plans to explore the clinical potential for HE2200 in hematopoeisis.
Preclinical studies with HE2200 and initial clinical results with the Company's lead IRH, HE2000, indicate that this class of compounds may 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. The loss of ability to mount a strong cell-mediated immune response seen in the elderly is believed to be a primary reason patients in this age group have difficulty recovering from infectious diseases such as the flu and pneumonia and also why vaccines in this population tend to be less effective. Preclinical studies with HE2200 have shown that the compound can reverse the loss of cell-mediated immunity seen in aged animals and that correcting this dysregulation with HE2200 treatment allows these animals to respond better to vaccination.
Additional preclinical studies show that HE2200 may also improve hematopoiesis (restoring neutrophils and platelets). A study recently published in the Annals of New York Academy of Sciences demonstrated immune protection for HE2200-treated animals exposed to whole-body radiation. The authors of the study concluded that treatment with HE2200 was providing this benefit by accelerating bone marrow recovery. As previously reported, the Company's lead IRH, HE2000, has demonstrated an ability to improve neutrophil and platelet counts in initial clinical studies in HIV patients. This finding, combined with its potential ability to improve cell-mediated immunity (which may have implications for slowing tumor growth), makes HE2200 and other IRHs of the company attractive potential drug candidates for use in improving immunity in immunosuppressed cancer patients.
In addition to its effects on vaccine enhancement and generation of neutrophils and platelets, HE2200 has also been shown to provide benefit in a preclinical model of ulcerative colitis, an autoimmune disorder that affects approximately a half-million people in the U.S. The study, presented at the 10th Annual National Inflammation Research Association symposium, indicated that HE2200 compared favorably with sulfasalazine, a current standard of care in the treatment of the disease. If further preclinical work in autoimmune models is successful, additional clinical studies may also be conducted in this area with the compound.
"We are excited about the opportunity to further advance our vision and build our leadership position in the area of immune regulating hormones by moving HE2200 into human clinical trials," stated Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "We are now involved in the clinical development of three drug candidates that are immune regulating hormones targeted at a wide variety of infectious diseases and immune system disorders. Our product pipeline and the number of disease indications we are pursuing is creating a diverse and broad array of opportunities with promising compounds that represent potential for tremendous future growth. We look forward to reporting clinical trial results of HE2200."
Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California, engaged in the development of products for the treatment of infectious diseases and immune systems disorders. The Company's vision is to become the world leader in immune regulating hormones and their application to numerous diseases. Hollis-Eden is currently testing its lead drug candidate HE2000 in Phase I/II and Phase II clinical trials in treatment naive HIV infected South African patients. The Company is also conducting a Phase I/II clinical trial with HE2000 in the United States in HIV infected patients failing at least their second antiviral drug regimen. Additionally the Company is pursuing clinical trials with HE2000 in malaria and hepatitis. Through its relationship with Aeson Therapeutics, the Company also has access to HE2500, which is in Phase II clinical trials in cardiovascular disease and actinic keratosis. For more information on Hollis-Eden, contact the Company's website at holliseden.com. |
