Harbor BioSciences Wraps Up Phase I/IIa Prostate Cancer Study
07 Febrero 2011 - 7:30AM
Harbor BioSciences
, Inc. (OTCBB:HRBR), a
biopharmaceutical company developing novel therapeutics for the
treatment of cancer, metabolic and inflammatory diseases, today
announced it is closing the clinical sites of its U.S.-based Phase
I/IIa clinical trial with Apoptone
® (HE3235) for
castration resistant prostate cancer (CRPC) – also referred to as
hormone resistant prostate cancer. The final statistics for the
study will be generated after all sites have been closed and the
database is locked. The results are not expected to change
significantly from the company's September 2010 update. The
Phase I/IIa data, which will include the final statistical
analysis, will then be transferred to the China State Institute of
Pharmaceutical Industry (CIPI), Harbor BioSciences' development
partner. That partnership was announced on January 19, 2011.
Apoptone, a novel steroid analog of a testosterone metabolite,
has been found to induce cell death (apoptosis) in prostate
tumors. The dose-response study was designed to determine
safety, maximum tolerated dose and biological activity of Apoptone
in both taxane-resistant and chemotherapy-naïve patients with CRPC.
The study was conducted with the Prostate Cancer Clinical Trial
Consortium (PCCTC) and other clinical sites. Harbor BioSciences
recently received a patent for the use of Apoptone in treating
breast and prostate cancer: U.S. Patent No. 7,863,261; and patent
applications are pending in various foreign countries. Patent
applications for formulations and solid-state forms of the compound
are also pending.
A total of 68 patients were treated with Apoptone at doses
ranging from 10 to 700 mg per day. The drug was judged to be
safe and well tolerated. Antitumor effects were noted in all
doses studied including the lowest dose. In some individuals,
there have been favorable responses in bone scans ranging from
decrease of tracer uptake to resolution of some bone tumors; and in
one patient there was a sustained partial response (RECIST) for
greater than six cycles following the first evaluation at cycle
two.
Data, analyzed using standard methodology for prostate cancer
research, demonstrate an effect on circulating tumor cells (CTC).
For patients who at baseline have favorable circulating tumor cell
counts (< 5), the majority remains favorable at 4 weeks (86.2%)
and for those with CTC enumeration at 12 weeks
(84.2%). Furthermore, for those patients with unfavorable CTC
(greater than or equal to 5), 26% become favorable at 4 weeks and
for those with counts at 12 weeks 62.5% become favorable. CTC
enumerations below 5 are associated with increased survival.
One patient at the highest dose group (700 mg) experienced a
drug-to-drug interaction with simvastatin that resolved after
cessation of both drugs and had not been observed at lower
doses. Because anti-tumor activity has been seen at all dose
levels, and a qualitative difference in this biological activity at
even higher doses is not expected, the company concluded that
further dose escalation represents a safety concern and that the
trial has provided sufficient information to proceed to a Phase IIb
study with a suitable partner. Additional clinical trials will
also be conducted by CIPI in China and Hong Kong; and with a
suitable partner(s) elsewhere, Harbor BioSciences will use CIPI's
data to support these further development efforts.
About Harbor BioSciences,
Inc.
Harbor BioSciences is a development-stage company with two
product candidates recently in clinical trials: Apoptone® (HE3235)
in the cohort expansion portion of a Phase I/IIa trial of patients
with late-stage prostate cancer, and Triolex® (HE3286), has
completed Phase IIa trials in obese type 2 diabetes mellitus
patients. Apoptone and Triolex represent two of the
lead candidates from Harbor BioSciences' small molecule platform
based on metabolites or synthetic analogs of endogenous human
steroids. For more information please visit
www.harborbiosciences.com.
This press release contains forward-looking statements within
the meaning of the federal securities laws concerning, among other
things, dose escalation in our Phase I/IIa trial; Apoptone's
inducement of cell death (apoptosis) in prostate tumors; the breath
of the soft tissue response; the continued tumor regression in the
patient who experienced a partial overall response; tolerability of
our drug in our Phase I/IIa trial; and ongoing efforts for
partnerships. Any statements included in this press
release that are not a description of historical facts are
forward-looking statements that involve risks, uncertainties,
assumptions and other factors which, if they do not materialize or
prove correct, could cause Harbor BioSciences' actual results to
differ materially from historical results or those expressed or
implied by such forward-looking statements. Such statements
are subject to certain risks and uncertainties inherent in the
Company's business, including, but not limited to: the ability to
complete preclinical and clinical trials successfully and within
specified timelines, if at all; the Company's capital needs; the
Company's ability to obtain additional funding; our ability to
obtain regulatory approval for Apoptone, Triolex, or any other
investigational drug candidate; and other risks detailed from time
to time in the Company's filings with the Securities and Exchange
Commission. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. Except
as required by law, Harbor BioSciences undertakes no obligation to
update or revise the information contained in this press release as
a result of new information, future events or circumstances arising
after the date of this press release.
CONTACT: Robert Weber
Chief Financial Officer
Harbor BioSciences, Inc.
(858) 587-9333
rweber@harborbiosciences.com
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