-----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, Rm6FqMo6OLT5CfP+5nUc7P3fHi03D1WLKcM1x0VLXpPsd23ZqxQo6J2PPHkp/KTz TaLSTt7G/L0jVL/CdGbwvA== 0000950144-07-009905.txt : 20071106 0000950144-07-009905.hdr.sgml : 20071106 20071106080244 ACCESSION NUMBER: 0000950144-07-009905 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071102 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071106 DATE AS OF CHANGE: 20071106 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Geovax Labs, Inc. CENTRAL INDEX KEY: 0000832489 STANDARD INDUSTRIAL CLASSIFICATION: COMPUTER & OFFICE EQUIPMENT [3570] IRS NUMBER: 870455038 STATE OF INCORPORATION: IL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52091 FILM NUMBER: 071215950 BUSINESS ADDRESS: STREET 1: 1256 BRIARCLIFF ROAD N.E. STREET 2: EMTECH BIO SUITE 500 CITY: ATLANTA STATE: 2Q ZIP: 30306 BUSINESS PHONE: 404 727-0971 MAIL ADDRESS: STREET 1: 1256 BRIARCLIFF ROAD N.E. STREET 2: EMTECH BIO SUITE 500 CITY: ATLANTA STATE: 2Q ZIP: 30306 FORMER COMPANY: FORMER CONFORMED NAME: DAUPHIN TECHNOLOGY INC DATE OF NAME CHANGE: 19940826 FORMER COMPANY: FORMER CONFORMED NAME: SUCCESSO INC DATE OF NAME CHANGE: 19910410 8-K 1 g10366e8vk.htm GEOVAX LABS, INC. GEOVAX LABS, INC.
 

 
 
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): November 2, 2007
 
GEOVAX LABS, INC.
(Exact name of registrant as specified in Charter)
         
Illinois
(State or other jurisdiction of
incorporation or organization)
  000-52091
(Commission File No.)
  87-0455038
(IRS Employee Identification No.)
1256 Briarcliff Road N.E.
Emtech Bio Suite 500
Atlanta, Georgia 30306
(Address of Principal Executive Offices)
(404) 727-0971
(Issuer Telephone number)
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 CFR240.14a-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© under the Exchange Act (17 CFR 240.13(e)-4(c))
 
 

 


 

     This Form 8-K and other reports filed by GeoVax Labs, Inc. (the “registrant”) from time to time with the Securities and Exchange Commission (collectively the “Filings”) contain forward looking statements and information that are based upon beliefs of, and information currently available to, the registrant’s management as well as estimates and assumptions made by the registrant’s management. When used in the Filings the words “anticipate”, “believe”, “estimate”, “expect”, “future”, “intend”, “plan” or the negative if these terms and similar expressions as they relate to the registrant or the registrant’s management identify forward looking statements. Such statements reflect the current view of the registrant with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to the registrant’s industry, operations and results of operations and any businesses that may be acquired by the registrant. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Item 8.01 Other Events
     On November 2, 2007 we issued a press release announcing excellent safety and immunogenicity results from our full-dose HIV/AIDS vaccine human trial which began in September 2006. A copy of the press release is attached to this Current Report.
Item 9.01 Financial Statements and Exhibits
     
Exhibit 99.1
  Press Release
SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: November 2, 2007
         
  GEOVAX LABS, INC.
 
 
  By:   /s/ Mark W. Reynolds    
    Mark W. Reynolds   
    Chief Financial Officer   
 

 

EX-99.1 2 g10366exv99w1.htm EX-99.1 PRESS RELEASE EX-99.1 PRESS RELEASE
 

Exhibit 99.1
AT THE COMPANY
Donald Hildebrand/Jennifer Nelms
(404) 727-0971
FOR IMMEDIATE RELEASE
02 November 2007
Excellent Results Received from GeoVax’s Full-Dose HIV/AIDS Vaccine Trial
ATLANTA, Ga., 02 Nov 2007 — GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta based biotechnology company, announced today excellent safety and immunogenicity data from its full-dose HIV/AIDS vaccine human trial which began in September 2006.
This full-dose trial is the second in a series of four Phase 1 human trials designed to test the safety and immunogenicity of the GeoVax HIV/AIDS vaccines. Involving 36 participants of which 30 received vaccine and 6 received placebo, this trial protocol included vaccination with two full-doses of GeoVax’s DNA vaccine to prime the immune response followed by two full-doses of GeoVax’s MVA vaccine to boost the immune response. GeoVax’s DNA and MVA vaccines express over 50% of the AIDS virus (HIV-1) protein components in order to stimulate a broad anti-HIV immune response. The vaccines cannot cause AIDS because they do not include complete virus. A Phase 1 human trial, started in April 2006, evaluated the delivery of only 1/10th of the full dosage and utilized the same vaccine regimen evaluated in the full dose trial.
From data collected from the 26 participants who completed the trial, the following positive conclusions were observed:
    GeoVax HIV/AIDS vaccines, both DNA and MVA, continue to demonstrate that they are quite safe and immunogenic following the delivery of the four full-doses (two of each vaccine) used in the trial’s protocol
 
    The full-dose regimen of GeoVax vaccines continues to be well tolerated without any type of reaction, mild or systemic, in the majority of participants
 
    CD4 T-cell responses are high in both the low and full-dose regimens, 84% and 78% of participants
 
    CD8 T-cell responses are present in 42% of the full-dose recipients and 33% of the 1/10th dose recipients.
 
    Antibody responses to the envelope glycoprotein (Env) increased following the fourth vaccination, and were present in 88% of the full-dose participants
 
    Delivery of the fourth vaccination increased the frequency and magnitude of the CD8 T-cell and Antibody responses
Two additional Phase 1 human trials testing different vaccine regimens started in June 2007 and are currently in process. Planning of a large Phase 2 trial is underway and tentatively scheduled for a mid-2008 start.
“These results extend the earlier positive results for both our full and 1/10th dose groups to a larger number of volunteers,” says Dr. Harriet Robinson, GeoVax Chief Scientific Advisor.

 


 

“They are extremely encouraging and provide a strong foundation for proceeding with phase 2 human testing.”
The human trials, testing GeoVax’s HIV/AIDS vaccines, are conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded and supported by the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. Preclinical work enabling the development of the clinical evaluation of GeoVax’s DNA and MVA vaccines was funded by the National Institute of Allergy and Infectious Diseases of the US National Institute of Health. The NIH recently provided additional support to GeoVax’s vaccine development program in the form of a $15 million IPCAVD grant awarded in October 2007.
* * * * * * * * * * * * * * *
About GeoVax Labs, Inc. (www.geovax.com)
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax’s vaccine technology is protected by 20 filed patent applications and issued patents.
GeoVax HIV/AIDS vaccines are designed to prevent development of Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, by vaccinating individuals prior to infection with the AIDS virus. In addition, GeoVax AIDS vaccines may be effective as therapeutics (treatment of people infected with AIDS virus). Studies evaluating these vaccines in already HIV/AIDS infected individuals are being planned.
GeoVax DNA and Recombinant MVA HIV/AIDS vaccines:
    Use DNA vaccines to “prime” immune responses and MVA vaccines to “boost” immune responses against the AIDS virus
 
    Vaccinate against more than 50% of AIDS virus components and can not cause AIDS
 
    Protected 22 of 23 (96%) non-human primates against the development of AIDS for over 3 1/2 years
 
    Are manufactured & tested under GMP/GLP — EMEA (EU) and FDA guidelines
 
    Satisfactorily completed earlier DNA HIV/AIDS vaccine Phase 1 human trial
 
    Are currently being tested in 4 Human Trials. Two started in 2006, two in summer 2007
 
    Have been demonstrated safe to date in human trials
 
    Are demonstrating positive immune responses against HIV in the majority of vaccine recipients
 
    Are in planning stage for a larger Phase 2 human trial in 2008
For further information, contact Don Hildebrand or Jennifer Nelms at (404) 727-0971 or visit www.geovax.com.

 


 

Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Company’s Securities and Exchange Commission filings and report.

 

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