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Wednesday, February 24, 2010 8:56:01 AM
SAN DIEGO, Feb. 24 /PRNewswire-FirstCall/ -- Harbor BioSciences, Inc. (Nasdaq:HRBR - News) today announced that the company has received a notice of allowance from the United States Patent Office of patent claims covering the use of its lead product candidate Apoptone®. The patent claims cover the use of Apoptone to treat prostate cancer, breast cancer and benign prostatic hypertrophy. Apoptone (HE3235) is a novel synthetic steroid analog of a dihydrotestosterone metabolite and has been found to stimulate cell death (apoptosis) in animal models of prostate and breast cancers.
Apoptone is a first-in-class oral compound in a Phase I/IIa clinical trial in late-stage prostate cancer patients who have failed hormone therapy and at least one round of taxane-based chemotherapy treatment. Currently there is no effective treatment for late-stage prostate cancer, the second leading cause of death in men in the United States. 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 treatments for hormone and chemotherapy refractory prostate cancer and the survival time is estimated to be between 8 and 12 months.
About Harbor BioSciences, Inc.
Harbor BioSciences is a development-stage company with two product candidates 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®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. Apoptone and Triolex represent the lead candidates from Harbor BioSciences' small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones. For more information on Harbor BioSciences please visit www.harborbiosciences.com.
This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, our focus on attaining proof-of-concept data for Apoptone in its initial indication of CRPC; and the continuation of treatment, with Apoptone, of men with CRPC for the balance of 2010 under our current Apoptone Phase Ib/IIa Clinical Trial protocol. Any statement 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 (HE3235), Triolex (HE3286) 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.
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