updated 2/28/2011 8:45:49 AM ET 2011-02-28T13:45:49

SAN DIEGO, Feb. 28, 2011 (GLOBE NEWSWIRE) -- 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

© Copyright 2012, GlobeNewswire, Inc. All Rights Reserved


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