MONROVIA, CA--(Marketwire - Mar 7, 2013) - 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:
RECENT ARTICLES & LINKS FOR RELATIVE AIDS-HIV MEDICINE & BABY HIV CURES
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.