FDA Grants GeoVax Labs, Inc. Request For Pre-IND Meeting
Wed, 11/18/2009 - 3:38am
GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, has announced that the 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. Robert McNally, Ph.D., president and chief executive officer, stated, "In anticipation of a pre-IND meeting in mid December, we have submitted a pre-IND information packet to the FDA. This packet includes rationale and supporting data for each question in the pre-IND package to allow a response from the FDA. The main purpose of the Pre-IND meeting is to ensure the FDA understands the purpose, approach and endpoints for the anticipated Phase 1 therapeutic trial and that we have answers to all of our questions to the FDA prior to filing the actual IND. "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." A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The Phase 1 therapeutic protocol stresses safety parameters to minimize any risk to the volunteers. The protocol, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), has specific objectives to optimize safety while evaluating the ability for the vaccine to elicit protective immune responses in vaccinated participants. The proposed trial is based on the achievement of excellent post-vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University. The proposed human trial follows the precedents set in the preclinical animal trials and is a critical step towards developing a therapeutic vaccine for HIV-1 infected humans. 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.