-----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, UQ+3EV6dssUqlhEODVF/1VMtEoZHtHyhtoHTDPA5nYISkMAUqETUKuWm4UgDanRC sjFsLlnFzMKxhVyncPTLOg== 0001181431-10-014269.txt : 20100305 0001181431-10-014269.hdr.sgml : 20100305 20100305160805 ACCESSION NUMBER: 0001181431-10-014269 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20100305 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20100305 DATE AS OF CHANGE: 20100305 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: 10660791 BUSINESS ADDRESS: STREET 1: 4435 EASTGATE MALL STREET 2: SUITE 400 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 858-587-9333 MAIL ADDRESS: STREET 1: 4435 EASTGATE MALL STREET 2: SUITE 400 CITY: SAN DIEGO STATE: CA ZIP: 92121 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 rrd268230.htm 8-K 7.01 FD DISCLOSURE - PRESS RELEASE 050810 Prepared By R.R. Donnelley Financial -- Form 8-K
 
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):  03/05/2010
 
Harbor BioSciences, Inc.
(Exact name of registrant as specified in its charter)
 
Commission File Number:  000-24672
 
DE
  
13-3697002
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
4435 Eastgate Mall, Suite 400, San Diego, CA 92121
(Address of principal executive offices, including zip code)
 
858.587.9333
(Registrant’s telephone number, including area code)
 
(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 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 a mended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.

 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
           
Hollis-Eden Pharmaceuticals, Inc.
 
 
Date: March 05, 2010
     
By:
 
/s/    /Robert Weber/
               
Robert Weber
               
Chief Financial Officer
 
 
-----END PRIVACY-ENHANCED MESSAGE-----