-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, P9Z/ZuD4tRq9JWF9/YfaA9ANrKQqjJqlQsiPPHH46mlupukWTjnt4v319tsz9uuI qUFcDaFH3t0QpNBEm0H2YQ== 0001171843-11-000321.txt : 20110207 0001171843-11-000321.hdr.sgml : 20110207 20110207083037 ACCESSION NUMBER: 0001171843-11-000321 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110207 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110207 DATE AS OF CHANGE: 20110207 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Harbor BioSciences, Inc. CENTRAL INDEX KEY: 0000899394 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133697002 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34584 FILM NUMBER: 11576464 BUSINESS ADDRESS: STREET 1: 9171 TOWNE CENTRE DRIVE STREET 2: SUITE 180 CITY: SAN DIEGO STATE: CA ZIP: 92122 BUSINESS PHONE: 858-587-9333 MAIL ADDRESS: STREET 1: 9171 TOWNE CENTRE DRIVE STREET 2: SUITE 180 CITY: SAN DIEGO STATE: CA ZIP: 92122 FORMER COMPANY: FORMER CONFORMED NAME: HOLLIS EDEN PHARMACEUTICALS INC /DE/ DATE OF NAME CHANGE: 19970410 FORMER COMPANY: FORMER CONFORMED NAME: INITIAL ACQUISITION CORP DATE OF NAME CHANGE: 19930329 8-K 1 document.htm FORM 8-K FILING DOCUMENT Form 8-K Filing

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K


CURRENT REPORT

Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) February 7, 2011  


Harbor BioSciences, Inc.
(Exact name of registrant as specified in its charter)


Delaware
 
001-34584
 
13-3697002
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer Identification No.)


 
4435 Eastgate Mall, Suite 400
San Diego, California
 
92121
 
  (Address of principal executive offices)   (Zip Code)  

Registrant's telephone number, including area code:   (858) 587-9333



________________________________________________________________________________
(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
    [    ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    [    ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    [    ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    [    ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01. Other Events.

On February 7, 2011 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

    Exhibit 99.1.       Press release dated February 7, 2011


SIGNATURE

    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

    Harbor BioSciences, Inc.
(Registrant)

February 7, 2011
(Date)
  /s/   ROBERT W. WEBER
Robert W. Weber
Chief Financial Officer


  Exhibit Index
  99.1 Press release dated February 7, 2011






EX-99.1 2 newsrelease.htm PRESS RELEASE Harbor BioSciences Wraps Up Phase I/IIa Prostate Cancer Study

EXHIBIT 99.1

Harbor BioSciences Wraps Up Phase I/IIa Prostate Cancer Study

SAN DIEGO, Feb. 7, 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 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 abi lity 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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