Immunotech Laboratories Begins Regulatory Process With US Food & Drug Administration
April 26 2013 - 9:00AM
Marketwired
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.
www.inddirections.com
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.
www.immunotechlab.com
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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Company Contact: Immunotech Laboratories, Inc. Email Contact
Public Relations: The Nabors Group 713-875-9200 E-mail: Email
Contact www.facebook.com/Naborsgroup
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