-----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, ON7SfiPgsVpd9UkuK2fvribM+2aqiC/NlMFgFFuKS4Jx2zH6kahMPCPLlaxAxx5J XJE4rijDVXi7f6PSGTuDuA== 0000950133-04-003722.txt : 20041008 0000950133-04-003722.hdr.sgml : 20041008 20041008102700 ACCESSION NUMBER: 0000950133-04-003722 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040707 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041008 DATE AS OF CHANGE: 20041008 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENVEC INC CENTRAL INDEX KEY: 0000934473 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232705690 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24469 FILM NUMBER: 041071326 BUSINESS ADDRESS: STREET 1: 65 W WATKINS MILL RD CITY: GAITHERSBURG STATE: MD ZIP: 20878 BUSINESS PHONE: 2406320740 MAIL ADDRESS: STREET 1: 65 W WATKINS MILL RD CITY: GAITHERSBURG STATE: MD ZIP: 20878 8-K 1 w03545e8vk.htm FORM 8-K e8vk
 

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):
October 7, 2004

GENVEC, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)
     
0-24469
(Commission File Number)
  23-2705690
(IRS Employer Identification No.)
     
65 West Watkins Mill Road, Gaithersburg, Maryland
(Address of Principal Executive Offices)
  20878
(Zip Code)

(240) 632-0740

Registrant’s telephone number, including area code

Not Applicable

(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))  

 


 

Section 8 – Other Events

Item 8.01 Other Events

     On October 7, 2004, GenVec, Inc. issued a press release announcing that the United States Food and Drug Administration issued a clinical hold on GenVec’s clinical trials of TNFerade™. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Section 9 – Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits

(c) Exhibits. The following exhibit is filed herewith:

       
  Exhibit No.   Description
 
 
       
 
99.1
  Press release, dated October 7, 2004.

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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.

             
    GENVEC, INC.
(Registrant)
 
           
Date: October 7, 2004
  By:   /s/ Jeffrey W. Church    
     
 
   
      Jeffrey W. Church    
      Chief Financial Officer, Treasurer and    
      Corporate Secretary    

2


 

EXHIBIT INDEX

     
Exhibit No.   Description

 
     
99.1
  Press release, dated October 7, 2004.

 

EX-99.1 2 w03545exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

     
(GENVEC LOGO)   65 West Watkins Mill Road
  Gaithersburg, MD 20878
  tel: 240-632-0740
    fax: 240-632-0735
    www.genvec.com

Rena Cohen, Corporate Communications

Tel: 240-632-5501

E-mail: rcohen@genvec.com

GENVEC ANNOUNCES CLINICAL HOLD ON TNFerade™ TRIALS

     GAITHERSBURG, MD (October 7, 2004) – GenVec (Nasdaq: GNVC) today announced that the U.S. Food and Drug Administration (FDA) has requested that clinical trials of TNFerade be placed on clinical hold, pending review of information pertaining to a potential increase in the incidence of blood clots in patients with esophageal cancer who received the highest dose of TNFerade in a Phase 2 clinical trial. Interim results from this dose-escalation trial were reported by GenVec and presented at the European Organization for Research and Treatment of Cancer (EORTC) meeting in Geneva, Switzerland on October 1, 2004. GenVec will be providing additional data to the FDA over the next several days and expects to receive a letter from the agency confirming the clinical hold and providing details of the follow up actions needed before the company can resume clinical trials. TNFerade is currently in Phase 2 clinical studies for locally advanced pancreatic, esophageal, and rectal cancer.

     “Our patients’ safety is very important to us. We are responding quickly to the FDA and look forward to addressing their questions, and will provide an update on the

1


 

status of our discussions as soon as more substantive information is available,” said Paul H. Fischer, Ph.D., GenVec’s President and CEO.

     GenVec is a biopharmaceutical company developing treatments for cancer, heart disease, vision loss, and vaccines for infectious diseases. Additional information on GenVec is available at www.genvec.com and in GenVec’s various filings with the Securities and Exchange Commission. A copy of the poster presented at the EORTC meeting on October 1, 2004 is also available on the Company’s website at www.genvec.com.

     Statements herein relating to GenVec’s continued development of TNFerade, future business performance, or strategies are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. These include the timing and content of future FDA regulatory actions, unexpected results in future clinical trials and related analyses, any required additional research and testing, and risks relating to the early stage of GenVec’s product candidates under development. Further information on the factors and risks that could affect GenVec’s business, financial conditions and results of operations, are contained in GenVec’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.

###

2

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