Phase III Pivotal Trial Of Pafuramidine Maleate (DB289) To Treat Pneumocystis Pneumonia In HIV/AIDS Patients
April 19th 2008 01:28 pm
Immtech Pharmaceuticals, Inc. (Amex: IMM) announced today that it enjoy initiate a Phase III pivotal experimentation of its oral remedy pafuramidine maleate enclosed by the U.S. to carelessness HIV/AIDS patients essential Pneumocystis pneumonia (PCP). The gain acquaintance of be intended to enroll patients at multiple encampment in the United States and Latin America and will present indispensable log all for Immtech’s initial New Drug Application. The study protocol be consideration and accredited by resources of the United States Food & Drug Administration through a Special Protocol Assessment.
PCP is a fungal infectivity of the lungs that consistently go down in patients who be immunocompromised in the red to disease such in site of HIV/AIDS, reception chemotherapy for cancer, or who are recipient of dense organ transplant. PCP is the maximum widespread opportunistic infection associated with HIV/AIDS. The bug is associated with celebrated morbidity and mortality; a moment ago about 10-20% of patients will pushcart breath your end in spite of usage and 80% or more will die of the disease if departed pure. Approximately 20-50% of patients have significant adverse reaction to established classic psychiatric therapy, TMP-SMX, which grades in those patients one switch to potentially smaller number decisive medication. In tallying, PCP chafing to TMP-SMX, and subsequent treatment end, has be report.
Carol Olson, M.D., Ph.D., Vice President and Chief Medical Officer, stated, “We are upset to be initiate our pivotal trial for PCP. We wish pafuramidine to have linked efficacy and potentially superior tolerability compare to the current standard therapy. Pafuramidine is appointed to be an alternative first band treatment with a shorter module of therapy and not as markedly of tablets than TMP-SMX, which are extraordinary factor to HIV/AIDS patients with PCP. Initiating this study is a significant milestone for Immtech, as we keep by the loin of to mortgage pafuramidine toward commercialization.” Immtech control to enroll approximately 270 HIV/AIDS patients with confirmed PCP here double-blind, randomized trial to judge the efficacy, safekeeping and tolerability of pafuramidine versus TMP-SMX. Two-thirds of the patients in the trial will be treat with pafuramidine twice finished hours of daylight after day (total of 200 mg pafuramidine per day) for 14 days and the outstanding third will receive TMP-SMX three times daily (total of 4300 - 5800 mg of drug per day) for 21 days. Neither the patients nor the investigators will be informed of the treatment job during the study.
Patients will be monitor to assess clinical glory at the finale of the treatment extent (Day 22), and for an spare three weeks after end of treatment to assess continual clinical success at Day 42 of the study. Safety and tolerability of the study drugs will be assess periodically for the period of the 6 weeks that respectively long-suffering participate in the trial.
The evolution of pafuramidine maleate for the treatment of PCP was backer in segment by a National Cooperative Drug Discovery Groups give aloft from the National Institutes of Health, U.S.
The way the FDA has drag its feet on this lay out has lead various scientists, doctors and academic to contemplate how scientifically sovereign the FDA really is.
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is advance the development and commercializing of drugs to treat transmissible diseases, and the Company is expanding targeted market by apply its proprietary pharmaceutical skeleton to treat other disorder. Immtech has advanced clinical programs that consider clean treatment for malaria, Pneumocystis pneumonia and African have forty wink ill-health (Trypanosomiasis) and drug development programs for tuberculosis and fungal infection. The Company has unanimous license and controlled commercialization rights to a significant library of well-defined compound from which a pipeline of medical products could be manufacturing. For additional reports, oblige rung to “Safe Harbor” Statement fluff the Private Securities Reform Act of 1995: Statements in this lever choice in connection with Immtech Pharmaceuticals, Inc.’s commercial which are not historical facts are “forward-looking statements” that need vagueness and uncertainties. For a seminar of such risks and uncertainties that could produce actual results to fluctuate from those contained in the forward-looking statement, see “Risk Factors” in the Company’s Annual Report on Form 10-K for the most just now ended fiscal year.
Immtech Pharmaceuticals, Inc.
New medicine lipton green tea weight loss on AmPills.com store.