8-K 1 v051657_8k.htm Unassociated Document
 


 
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): August 29, 2006
 

  Cellegy Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
 


Delaware
 
0-26372
 
82-0429727
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
 
1800 Byberry Road, Bldg. 13
Huntingdon Valley, Pennsylvania
 
19006
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (215) 914-0900
 

 
(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 (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
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 August 28, 2006, Cellegy Pharmaceuticals, Inc. (“Cellegy” or the “Company”) announced that the Data Monitoring Committee (DMC) reviewing interim data from the Savvy® Nigeria Phase 3 HIV prevention trial made the recommendation that continuing the trial would not allow the effect of Savvy (C31G vaginal gel) on HIV to be determined because of a lower than expected rate of HIV seroconversion in the trial, which was less than half of the expected rate. This lower rate was possibly due in part to procedures designed to ensure ethical trial design, including counseling on HIV prevention and distribution of condoms.

After examining the trial’s data, the DMC indicated that continuation of the trial was not warranted due to a lack of statistical significance in the data. Cellegy, Family Health International and the United States Agency for International Development, which is funding the trial, collectively agreed that the trial in Nigeria should be discontinued. The Savvy Phase 3 contraception trial underway in the United States will continue as planned.

A copy of the Company’s press release relating to the above matters is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits
 
 
 
 
 
Exhibit List
 
Description of Exhibit
 
 
 
 
 
Exhibit 99.1
 
Press Release dated August 28, 2006

 

SIGNATURE
 
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.  
 
 
 
 
 
 
 
CELLEGY PHARMACEUTICALS, INC.
 
 
 
 
 
 
Date: August 29, 2006
By:  
/s/ Robert J. Caso
 

Robert J. Caso
 
Vice President, Finance
(Duly Authorized Officer)