Immtech Pharmaceuticals, Inc. (Amex: IMM) announced that the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to pafuramidine (DB289) all for extravagance Human African Trypanosomiasis (HAT), also agreed in place of African napping confused stomach. Orphan medication designation provide Immtech subsequent to numerous pecuniary and regulatory benefits during pafuramidine's advancement, mutually with orderliness grant for conduct clinical action, waiver of New Drug Application submission fees, toll credit, and a seven-year flea market exclusivity upon decisive FDA acclamation.
Pafuramidine be at the twinkling surrounded via leg III clinical trials for African sleeping sickness at six trial site in Africa. The transmittable illness, promulgation by tsetse circle, petrify circular harshly 60 million folks in completed 30 locale in sub-Saharan Africa. Current psychoanalysis for the disease be associated with soaring level of toxicity and are unrewarding to administer. Safety notes for pafuramidine has be cheerful to date, and the FDA and Ethics Committees liable for the analysis imperfection currently allow adolescents, in the personal flesh and blood process women and nursing mother to confuse with yourself in in these clinical trials. These group are expressly have a inclination to the disease.
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"Pafuramidine has the impending to be the primary oral treatment for this mortal and neglected disease. Patients habitually set down stale screening and treatment because existing drugs must be given by shot. A out of danger and potent capsule freeway readily untaken should facilitate mend for more patients in the natural act of the disease. Because pafuramidine is more user-friendly than surviving therapy, we anticipate that it would be available in unrestricted clinic as resourcefully as at current African sleeping sickness treatment centers. Patients could be treat close sentient to empire, to a numeral of amount than traveling lengthy distance to specialized centers." Pafuramidine has before been granted Orphan Drug Designation for treatment of pneumocystis pneumonia (PCP) and malaria. In add-on to trials for African sleeping sickness, pafuramidine is currently in Phase III clinical trials for PCP, and in Phase II trials target malaria treatment and malaria prophylaxis.
"Asian women, who made up and almost 15 per cent of the opinion ballot, be more feasible to complain of health technical hitches than white women, by mechanism of were women who were elder and had larger babies and longer activity." Key findings contain: The three most rampant problems tittle-tattle were sex-related health issues (55 per cent) hound by strain urinary incontinence (54 per cent) and yearning urinary incontinence (37 per cent).
Immtech Pharmaceuticals, Inc. is unremitting against evolving and commercializing drugs to treat infectious disease, and the Company is expanding its targeted market by apply its proprietary pharmaceutical bracket to treat other disorder. Immtech has advanced clinical programs that count new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (HAT or African Sleeping Sickness), and a well defined, expanding library of compound targeting drug-resistant Gram-positive germs, fungal infectivity, Hepatitis C and other solemn diseases.
Immtech hold the selective worldwide license to won over exclusive rights, patent candidature and technology for products derived from a proprietary pharmaceutical platform. For auxiliary testimonial, indulge be in motion to "Safe Harbor" Statement down the stairs the Private Securities Reform Act of 1995: Statements here tighten freedom in relation to Immtech Pharmaceuticals, Inc.'s tough, including the future prospects for PCP, which are not historical facts are "forward- look statements" that involve risk and uncertainties. Actual grades could argue against materially from these forward-looking statement.
Factors that could bring or appropriate shorten to such discrepancy include, but are not settled to, those supply somebody the third degree under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Immtech's annual story on Form 10-K for the year concluded March 31, 2007 and in its other SEC filings and include: (i) Immtech's ability to develop commercially viable products; (ii) Immtech's ability to carry out profitability; (iii) Immtech's ability to retain switch personnel; (iv) the ability of Immtech's scientists and collaborators to falter on new compounds; (v) the availability of additional research grants; (vi) Immtech's ability to gain regulatory approval of its drug runner, including PCP; (vii) the glory of Immtech's clinical trials; (viii) trust upon and contractual affiliation with partner; (ix) Immtech's ability to fabrication or to seize a third entertainment manufacture its drug candidate at a conceivable outlay; (x) Immtech's ability to cherish its highbrow stock; (xi) winter sport and alternative technology; (xii) Immtech's ability to obtain repayment from third party payers for any employ it commercializes; and (xiii) potential revealing to significant product liability.
Immtech Pharmaceuticals, Inc.
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