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Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies of Apoptone (HE3235) at AACR Molecular Targets and Cancer Therapeutics Conference
Date:11/16/2009

This results in an increase in tumor cell PSA expression followed by induction of apoptosis, which releases PSA into circulation. As tumor cell death occurs, the PSA is expected to decline or stabilize.

"Based on the encouraging responses and the tolerability profile we have seen in these end-stage patients, we are dose-escalating to 200 mg per day," commented Dr. Montgomery. "As we track time to progression through further treatment cycles, we expect that PSA levels will remain stable or continue to decline, consistent with the unique mechanism of this drug, which is distinct from other compounds in later-stage development for CRPC."

Howard Scher, M.D., Chief of the Genitourinary Oncology Service at the Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan-Kettering and Principal Investigator of the PCCTC, added: "These data provide initial evidence of activity in late-stage prostate cancer. The next step will be to expand the subject eligibility criteria to include earlier-stage, chemotherapy-naive patients in a controlled Phase II trial."

APOPTONE Clinical Trial Design

The study is an open-label study with the primary objective of assessing safety, tolerance, PK and activity of Apoptone in men with CRPC and an ECOG PS of <2 who failed at least one taxane-containing chemotherapy regimen and either radiographically or biochemically progressed. Patient cohorts are defined by oral twice-daily doses of 10 mg, 20 mg, 30 mg, 50 mg, 100 mg or higher (MTD has not yet been reached). Subjects are treated on 28-day cycles until toxicity or disease progression; CT and bone scans are obtained every two cycles to assess progression.

About Prostate Cancer

Over one million men in the United States have prostate cancer; approximately 90,000 of these patients have late-stage prostate cancer, resulting in approximately 28,000 deaths each year. There are currently no approved treat
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SOURCE Hollis-Eden Pharmaceuticals, Inc.
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