-----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, FvKx3TxrmOWAjZFY2gBPQRU5hg/YUopZrYRf+Vi0CdCGiK81gvMhlQp47StXnVrn Dulk0lLxCsv4+CxgGyMNBQ== 0000950123-10-030950.txt : 20100331 0000950123-10-030950.hdr.sgml : 20100331 20100331170155 ACCESSION NUMBER: 0000950123-10-030950 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100330 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100331 DATE AS OF CHANGE: 20100331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GeoVax Labs, Inc. CENTRAL INDEX KEY: 0000832489 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 870455038 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52091 FILM NUMBER: 10720124 BUSINESS ADDRESS: STREET 1: 1900 LAKE PARK DRIVE STREET 2: SUITE 380 CITY: SMYRNA STATE: 2Q ZIP: 30080 BUSINESS PHONE: 678-384-7220 MAIL ADDRESS: STREET 1: 1900 LAKE PARK DRIVE STREET 2: SUITE 380 CITY: SMYRNA STATE: 2Q ZIP: 30080 FORMER COMPANY: FORMER CONFORMED NAME: Geovax Labs, Inc. DATE OF NAME CHANGE: 20061002 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 c98649e8vk.htm FORM 8-K 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): March 30, 2010

GEOVAX LABS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   000-52091   87-0455038
(State or other Jurisdiction of Incorporation)   (Commission File Number)   (IRS Employer Identification No.)
     
1900 Lake Park Drive, Suite 380
Smyrna, Georgia
  30080
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (678) 384-7220
 
 
(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:

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))

 
 

 

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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 March 30, 2010 we issued a press release announcing that we are now allowed by the U.S Food and Drug Administration to begin a Phase 1 clinical trial for our therapeutic vaccine, which is intended as treatment for individuals infected with HIV (Human Immunodeficiency Virus). A copy of the press release is attached to this Current Report as Exhibit 99.1.

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: March 31, 2010

GEOVAX LABS, INC.

By: /s/ Mark W. Reynolds            
Mark W. Reynolds
Chief Financial Officer

 

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EX-99.1 2 c98649exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
Exhibit 99.1
(GEOVAX LOGO)
Contact
At the Company:
Robert McNally, President & CEO
(678) 384-7220 or rmcnally@geovax.com
At The Investor Relations Group:
Investor Relations
James Carbonara / Jason Strominger
or
Public Relations
Janet Vasquez / Robin O’Malley
(212) 825-3210
FOR IMMEDIATE RELEASE
MONDAY, MARCH 30, 2010
GEOVAX LABS GRANTED ALLOWANCE BY FDA TO START PHASE 1
CLINICAL TRIAL FOR HIV/AIDS THERAPEUTIC VACCINE
Company Will Begin Non-Blinded Study in HIV Infected Individuals
Who Started Drug Treatment During Their First Year of Infection
SMYRNA, GA — March 30, 2010 — GeoVax Labs, Inc. (OTCBB: GOVX), a biotechnology company that creates, develops, and tests innovative HIV/AIDS vaccines, is now allowed by the FDA (US Food and Drug Administration) to begin a phase 1 clinical trial for GeoVax’s therapeutic vaccine, which is intended as a treatment for individuals infected with HIV (Human Immunodeficiency Virus). The company will begin a non-blinded study in HIV infected individuals who started drug treatment during their first year of infection.
Robert McNally, Ph.D., President and CEO of GeoVax, stated, “Based upon preclinical animal data, we believe our therapeutic vaccine may improve treatment options for people infected with HIV and are delighted we will be able to begin a phase 1 clinical trial. An unmet need exists in the market for a HIV therapeutic vaccine if it can reduce the need for expensive and poorly tolerated lifelong oral medications currently available to infected individuals. We also recognize that this trial will enable GeoVax to gather crucial information toward our vaccine’s success on a more timely basis than the time required to perform a preventative trial. ”
The protocol for the Phase 1 clinical trial, conceived in collaboration with ARCA (AIDS Research Consortium of Atlanta), will carefully monitor safety while evaluating the ability of the vaccine to elicit protective immune responses in vaccinated participants. The next step of starting the process will be a submission by ARCA to the IRB (Institutional Review Board) for local review of trial documentation, a standard requirement to protect human subjects. The trial is based on the achievement of post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.
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About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus — AIDS) and other infectious agents. Our goals include developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting human trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. All preventative phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA AIDS vaccines in human volunteers for their demonstrated ability to raise anti-HIV immune responses as well as for their safety. Successful results from all phase 1 testing supported the initiation of the first phase 2 testing. GeoVax’s phase 2 human trial began in January 2009 and will involve 225 participants at sites in the United States and South America. Long term, we expect that GeoVax will grant manufacturing and distribution rights in several global markets in return for upfront fees, collaborative development agreements, and royalties on sales and distribution revenues. Internal vaccine manufacturing and distribution will also be considered by GeoVax. For more information, please visit www.geovax.com.
Forward-Looking Statements
Certain statements in this document are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVax’s filings with the Securities and Exchange Commission including those set forth at “Risk Factors” in GeoVax’s Form 10-K.
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