FDA Grants GeoVax Labs Inc. Request For Pre-IND Meeting
Published: Nov 17, 2009
ATLANTA, Nov. 17 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that the U.S. Food and Drug Administration (FDA) has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for GeoVax's therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package. Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial.
"While there are no guarantees of success for our therapeutic IND package, the pre-IND process helps ensure that our IND will adequately address any concerns the FDA may have about the proposed therapeutic trial," Dr. McNally added. "We understand the extreme need for this vaccine and we understand the process necessary to navigate forward."
The IND process is expected to take a number of months to complete. Based on the Company's current progress, commencement of the trial is targeted for early 2010.
About GeoVax Labs, Inc.
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 AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person become infected. GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for people already infected with the HIV-1 virus).
GeoVax's AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $17 million IPCAVD grant awarded in late 2007.
CONTACT: Robert McNally of GeoVax Labs, Inc., +1-678-384-7222,
email@example.com; or Leslie Loyet, Investor Relations, +1-312-640-6672,
firstname.lastname@example.org, or Nikki Snodgrass, Media Relations, +1-312-640-6732,
email@example.com, both of Financial Relations Board
Web site: http://www.geovax.com/