Harbor Diversified Inc (HRBR)

[Camaro1093]

Form 8-K for HARBOR BIOSCIENCES, INC.

http://biz.yahoo.com/e/100305/hrbr8-k.html

5-Mar-2010

Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure

On March 6, 2010, R. Bruce Montgomery, M.D., lead investigator of the ongoing Phase I/IIa clinical trial for Harbor Biosciences, Inc.'s Apoptone(r) (HE3235) drug, will present updated data for Apoptone at the ASCO Genitourinary Cancers Symposium in San Francisco. Apoptone is a novel steroid analog of a dihydrotestosterone metabolite that has been found to induce cell death (apoptosis) in prostate tumors. Apoptone is intended for use in the treatment of castration resistant prostate cancer (CRPC), also referred to as hormone resistant prostate cancer. Initial results from this study, conducted with participating member sites of the Prostate Cancer Clinical Trial Consortium (PCCTC), were reported on November 16, 2009.

Dr. Montgomery's presentation will note several developments including that the Kaplan-Meier estimate (a standard statistical method for predicting the outcome of an ongoing study) for the median time to progression for the ongoing trial is 15.3 weeks and the range is between four and forty weeks. Due to early signs of activity, the 20 mg dose group was expanded to include 14 patients. Eleven of the patients were evaluable with an actual median time to progression of 20 weeks and the range of eight and twenty eight weeks.

Based on these encouraging signs of activity, the PCCTC recommended an extension of the current trial into patients that have not been treated with taxane chemotherapy. In the extension, subject eligibility criteria have been amended to include earlier-stage, patients who have not yet been treated with chemotherapy. Ten such patients have been enrolled to date and will be treated with 100 mg doses of Apoptone.

The information in this Current Report on Form 8-K shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to liability under such section, nor shall it be deemed incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.