respectively. For men in the United States

The protocol for this study allows for expansion of additional patientsin any dosing cohort upon signs of safety, activity or adequate concentrationsof APOPTONE found in the plasma of patients in a dosing cohort. If the Company and its clinical investigators elect to expand a dosingcohort to 20 or more patients upon satisfying the protocols criteria, thiscould essentially initiate the evaluation of APOPTONE in a Phase II study. The Phase I/II open-label dose ranging study is being conducted with selectclinical sites that are members of the Prostate Cancer Clinical Trial Consortium(PCCTC). The PCCTC membership sites currently participating in the Phase I/IItrial are: Memorial Sloan-Kettering Cancer Center, New York, University ofCalifornia San Francisco and the University of Washington, Seattle. Additionalclinical sites outside the PCCTC consortium have recently been opened to allowfor more rapid enrollment of patients into the planned expanded cohort(s). HRS tumors are themost common types of malignancy, representing 30 and 38 of all new cancercases in men and women, respectively. For men in the United States, prostatecancer is the second leading cause of deaths from cancer, following lung cancer.It has been estimated that one in six men will develop prostate cancer and onein 30 will die from this disease.

It is well documented that the aberrant growthof prostate cancer cells can be due to a mutation in a tumor suppressor genecalled PTEN, a natural inhibitor of the PI3/AKT pathway. The Company believes that the activation of the Raf/MEK/ERK pathway andsubsequent cytotoxic activity observed with APOPTONE preclinically to date,distinguishes APOPTONE from other steroid hormone based compounds that interruptthe binding of hormones to the cell receptor or block the ability of the body toproduce hormones. Over one million men in the United States have prostate cancer and theprevalence of late stage prostate cancer in the United States is approximately90 thousand patients of which approximately 28 thousand die each year. There arecurrently no approved treatments for end-stage prostate cancer and the survivaltime is estimated to be between 8 and 12 months.

Current treatments for prostatecancer focus on blocking testosterone and other hormones associated with diseaseprogression and chemotherapy and range in annual sales from $500 million to $1.8billion. Unfortunately these agents become ineffective at treating the diseaseas it is progressing, leaving late-stage prostate cancer an unmet medical need. About Hollis-Eden Pharmaceuticals, Inc.Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of aproprietary class of adrenal steroid hormones as novel pharmaceuticals for humanhealth.