Immunotech Announces Canadian Special Access Program Could Allow Legal Treatment of Company's Patented (IPF-ITV-1) AIDS-HIV T...
March 07 2013 - 9:12AM
Marketwired
Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) today announced
the company has entered negotiations with a Canadian Wellness
Organization for the use of Immunotech's Patented AIDS-HIV
Treatment.
Immunotech's Chief Scientific Officer commented, "Canada has a
Special Access Program (SAP) for Experimental Drugs for Treatment
of Life Threatening and Terminal Diseases, such as Immunotech's
IPF-ITV AIDS-HIV Treatment."
The SAP authorizes a manufacturer to sell a drug that cannot
otherwise be sold or distributed in Canada. Drugs considered for
release by the SAP include pharmaceutical, biologic, and
radiopharmaceutical products and upon satisfactory due diligence
and agreement of terms by both parties an agreement such as this
could be expedited to implement the legal treatment of the
IPF-ITV-1 Treatment in short order, which could result in helping
save lives of terminal patients right away. The results from these
patients could assist with the Clinical Trials for FDA approval in
the United States.
Background on the Special Access
Program
The SAP considers requests from practitioners for access to
non-marketed drugs for treatment, diagnosis or prevention of
serious or life-threatening conditions when conventional therapies
have been considered and ruled out, have failed, are unsuitable,
and/or unavailable. The regulatory authority supporting the program
is discretionary and a decision to authorize or deny a request is
made on a case-by-case basis by taking into consideration the
nature of the medical emergency, the availability of marketed
alternatives and the information provided in support of the request
regarding the use, safety and efficacy of the drug. This authority
however, does not extend to covering the cost of drugs and does not
take into consideration the cost of marketed alternatives. If
access is granted, the physician agrees to report on the use of the
drug including any adverse events encountered with such use, and
must account for all quantities received to both the SAP and the
manufacturer.
The SAP authorizes a manufacturer to sell a drug that cannot
otherwise be sold or distributed in Canada.
According to the CDC, millions of people worldwide are infected
today with HIV/AIDS.
More than 34 million people now live with the HIV/AIDS Virus
according to "amfAR" The Foundation for AIDS
Research.
Link to SAP Program & Application:
www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index_e.html
RECENT ARTICLES & LINKS FOR RELATIVE
AIDS-HIV MEDICINE & BABY HIV CURES
http://timesofindia.indiatimes.com//articleshow/18786108.cms?intenttarget=no
http://www.mccormick.northwestern.edu/news/articles/2012/10/david-kelso-HIV-clinical-trial-in-mozambique.html#.UTTtjmHF-PI.email
http://www.amfar.org/about_hiv_and_aids/facts_and_stats/statistics__worldwide/
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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