Harbor BioSciences Preclinical Study of Apoptone(R) in Breast Cancer Published in the International Journal of Breast Cancer
28 Febbraio 2011 - 2:30PM
Harbor BioSciences, Inc. (OTCBB:HRBR), a biopharmaceutical company
developing novel therapeutics for the treatment of cancer,
metabolic and inflammatory diseases, today announced publication of
the company's study of Apoptone (HE3235) against breast cancer in a
preclinical rat model. "17a-Ethynyl-5a-androstane-3α, 17B-diol
Treatment of MNU-induced Mammary Cancer in Rats," describes the
activity of Apoptone in a breast cancer model that is known for its
similarity to breast cancer in humans. The paper was published this
month in the International Journal of Breast Cancer (Volume 2011
(2011), Article ID 618757).
As described in the publication, Apoptone dramatically decreased
tumor size by inducing programmed cell death (apoptosis). A
molecular analysis showed that apoptosis was triggered by
decreasing the expression of genes that cancer cells use to
maintain their survival, and increasing the expression of genes
that promote apoptosis. Apoptone also decreased the expression
of genes that are associated with treatment failure in human breast
cancer. The preclinical study was conducted in collaboration
with Dr. Rajkumar Laksmanaswamy, the research director at the
Center of Excellence in Cancer Research at the Texas Tech
University Health Sciences Center.
Apoptone aggressively shrank established tumors and prevented
the appearance of new tumors in the rodent breast cancer
model. The rate of tumor volume reduction and degree of tumor
suppression after treatment cessation was similar for Apoptone and
tamoxifen. The anti-cancer activity of Apoptone was enhanced
when combined with a common chemotherapeutic drug docetaxel
(Taxotere®), without evidence of increased toxicity. The
combination of Apoptone and docetaxel destroyed existing tumor
cells better than either anastrazole (Arimidex®) or tamoxifen, the
most common therapies used to treat breast
cancer. Furthermore, Apoptone in combination with docetaxel
prevented the growth of new tumors for 60 days after therapy ended,
whereas new tumors rapidly appeared when anastrazole, docetaxel,
and tamoxifen were used as single agents.
Apoptone as a single agent was also highly active compared to
anastrazole and docetaxel and was similar to tamoxifen, although
based on current clinical results in prostate cancer, it is
expected that Apoptone would produce substantially fewer side
effects or toxicities in humans than any of the other single agent
therapies tested in this animal model. This expectation is
based on the observed modulation effects by Apoptone on signal
transduction pathways in hyperproliferating cells and the apparent
absence of interference with these same pathways in normal
cells.
"We are encouraged by these preclinical results, which suggest
that in addition to its activity against prostate cancer, with
funding, Apoptone is ready to enter clinical trials to address a
need for improved breast cancer treatment," commented James
Frincke, Ph.D., Harbor BioSciences Chief Executive Officer.
Dwight Stickney, M.D., Harbor BioSciences Chief Medical Officer,
added, "I was especially impressed by both the strength and the
durability of the anti-tumor response of Apoptone in combination
with docetaxel, along with the apparent lack of toxicity. A
similar enhancement of docetaxel was seen with Apoptone in a
prostate cancer model, supporting the concept that an
apoptosis-inducting drug may increase chemotherapy effects.
"
About Harbor BioSciences,
Inc.
Harbor BioSciences is a development-stage company with two
product candidates which recently completed Phase I/IIa clinical
trials: Apoptone® (HE3235) in patients with late-stage prostate
cancer, and Triolex® (HE3286) 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. 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. Forward-looking statements can be identified by
words such as "anticipates," "intends," "plans," "seeks,"
"believes," "estimates," "expects" and similar references to future
periods. Examples of forward-looking statements include, but
are not limited to, statements we make regarding Apoptone producing
substantially fewer side effects or toxicities in humans than any
of the other single agent therapies tested, Apoptone's readiness
for clinical trials, and an apoptosis-inducing drug increasing
chemotherapy effects.
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;
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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