Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies of Apoptone (HE3235) at AACR Molecular Ta
16 November 2009 - 3:00PM
PR Newswire (US)
BOSTON, Nov. 16 /PRNewswire-FirstCall/ -- Hollis-Eden
Pharmaceuticals, Inc. (NASDAQ:HEPH), today reported preliminary
results of its ongoing Phase I/II clinical trial with Apoptone®
(HE3235) for hormone-resistant prostate cancer (also called
castrate-resistant prostate cancer or CRPC). Presented at the
Molecular Targets and Cancer Therapeutics Conference, which is
co-sponsored by the AACR, NCI and EORTC, the poster is titled:
"Results of preclinical and clinical Phase I/II open-label
dose-ranging trial with HE3235, a synthetic adrenal hormone, in
Castrate Resistant Prostate Cancer (CRPC)." Apoptone (HE3235), a
novel steroid that is an analog of a dihydrotestosterone metabolic
pathway member, stimulates cell death (apoptosis) in
hormone-dependent prostate tumors. Presenting the data is the lead
investigator of the study, R. Bruce Montgomery, M.D., Associate
Professor, Department of Medicine, Division of Oncology, University
of Washington School of Medicine. The poster also included
supportive preclinical data. The interim results of the Phase I/II
study, which is being conducted with participating member sites of
the Prostate Cancer Clinical Trial Consortium (PCCTC), demonstrated
that 47% of subjects who were radiographically evaluable for
response had stable disease. With the assessment of progression
every 56 days, the median time to progression was 107 days.
Forty-three percent of the biochemically evaluable subjects
experienced a drop in PSA during treatment, with 33% equal to or
greater than a 50% decline. Individuals experienced increases in
PSA with stable disease. Plasma PSA increases are expected because
the mechanism of action is believed to involve inhibition of tumor
cell proliferation while the androgen receptor transcription
element is engaged, independent of the androgen receptor. 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