SOURCE: Immunotech Laboratories Inc.

Immunotech Laboratories Inc.

April 26, 2013 09:00 ET

Immunotech Laboratories Begins Regulatory Process With US Food & Drug Administration

MONROVIA, CA--(Marketwired - Apr 26, 2013) - Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) today announced the company has initiated the Pre-IND and IND process with the US Food & Drug Administration (FDA). The successful submission of an Investigational New Drug (IND) to FDA will permit Immunotech to conduct clinical trials designed to result in marketing approval for a new drug.

Harry Zhabilov, President and Chief Science Officer, along with Blaine Nabors, VP of business development, are commencing the development of Immunotech's HIV therapeutic peptide vaccine.

Immunotech has engaged the drug development and regulatory consulting firm, IND Directions, LLC, to assist Immunotech in its development and regulatory processes.

Dr. Patricia Williams, CEO of IND Directions, stated "An analysis of the needs for a successful Pre-IND and IND with FDA has been initiated and IND Directions will work closely with Immunotech to initiate a productive dialogue with FDA."

About IND Directions, LLC
IND Directions staff and collaborators have extensive experience in drug development from combined experience in the biotechnology and pharmaceutical industry, contract research services, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and legal and medical practice. The staff has broad capabilities across therapeutic areas and technology, from small and large molecules to gene therapy to cell-based therapies and vaccines. With this broad experience base, IND Directions provides strategic support in the preparation of comprehensive development plans and the resources and expertise to implement those plans. 

Patricia D. Williams, Ph.D., leads the efforts of IND Directions with over 30 years experience in drug development. Dr. Williams has held various management positions at Bristol-Myers, Eli Lilly, American Cyanamid, Glycomed, Ligand, Biochem Pharma, SRA Life Sciences, TherImmune, Gene Logic and Summit Drug Development Services. Teams under Dr. Williams' leadership have advanced over 50 small molecules and biologics into clinical development.

About Immunotech Laboratories
Immunotech Laboratories is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases such as HIV and AIDS.

Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Immunotech Laboratories, Inc. from time to time in its periodic reports filed with the SEC. IPF is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Immunotech Laboratories believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Immunotech Laboratories to establish the efficacy of IPF in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of IPF in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, Immunotech Laboratories or any other person that the objectives and plans of Immunotech Laboratories will be achieved should not regard the forward-looking statements as a representation.

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