Immtech Pharmaceuticals, Inc. (Amex: IMM) announced the achievement of intervening time analysis of its Phase III pivotal clinical research of Immtech's oral linctus entrant, pafuramidine. An self-sufficient Data Safety Monitoring Board (DSMB) conduct the interim analysis and recommended that the trial should propagate by way of intentional. The trial be evaluate the sanctuary and tolerability of pafuramidine, and compare pafuramidine's efficacy to pentamidine, a non-oral drug, delimited by means of extravagance Human African Tryanosomiasis (HAT), also know as African having forty wink queasiness.
African sleeping sickness is a lethal, vector-borne parasitic virus circulation by tsetse ascend that compel in the decree of 60 million race in sub- Saharan Africa. Current treatment in approve of the opening elaboration place of the disease cover pentamidine and suramin. Both of these intravenous drugs be associated beside chitchat lethal edge effects. If agreed, pafuramidine could become the first undamaging and final oral nurture for first-stage African sleeping sickness.
Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical Officer stated, "Successfully completing pafuramidine's Phase III interim analysis is a highest milestone subsequent to the bridleway to register pafuramidine for treatment of African sleeping sickness. The next major milestone will be to be full of the that will live forever patients wide-reaching the 12-month hunt wide open up and doing protocol and for Immtech to ferment the documents for the NDA submission. We aim to have pafuramidine approved to combat this shocking communicable disease." Enrollment here trial be completed ahead of time in 2007, and all patients are appointed to complete the 12-month follow up, which is the initial endpoint for the trial, in second quarter 2008. Subject to have favorable primary analysis grades, Immtech electioneer to submit a New Drug Application (NDA) to the US Food and Drug Administration in the second somewhat of 2008. The FDA have agreed to reflect on "accelerated approval" of the 12-month facts. The 24-month follow up data will be submit subsequently to fulfill requirements. The FDA has also granted to pafuramidine's African sleeping sickness manifestation Fast Track and Orphan Drug regard, which is expected to take faster consideration and take part for waiver of the Prescription Drug Users Fee.
HUMIRA offer controllable every-other-week dosing by subcutaneous injection (shot underneath the skin) via a purposely designed pre-filled syringe.
Gill, who was recently call to draw together with Congresswoman Rosa DeLauro to slice whichever of his results, noted that their ongoing Yale Precipitating Events Project (PEP) and the same study around the country have shown that mobility-the ability to reallocate concise assistance-is a nit-picking factor in an older person's volume to function one by one.
A DSMB is a committee of physician, scientists, and at smallest possible one non- medical river who review clinical trial data trim to ensure cushion of participant and to provide scientific and medical slip for the trial. The DSMB operate underneath a trial-specific Charter and also according to the trial protocol. The DSMB could recommend discontinue a trial if they scrutiny any decisive safety or efficacy difficulties for the theory test drug. The Charter also allows the DSMB to recommend halting the trial if enrollment is not adequate to complete the trial in a timely manner.
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is determined on growing and commercializing drugs to treat infectious disease, and the Company is expanding its targeted market by apply its proprietary pharmaceutical dais to treat other disorder. Immtech has advanced clinical programs that include investigational oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (HAT or African sleeping sickness), and a well defined, escalating library of merged target drug-resistant Gram-positive microbes, fungal infection, Hepatitis C and other intense diseases.
Immtech hold the predetermined complete license to abiding patent, rights application and technology for products derived from a proprietary pharmaceutical platform. For new gen, oblige progress to "Safe Harbor" Statement under the Private Securities Reform Act of 1995: Statements in this pull let off the lead in connection with Immtech Pharmaceuticals, Inc.'s company, with the wished-for prospects for PCP, which are not historical facts are "forward-looking statements" that confuse with risk and uncertainties. Actual results could vary materially from these forward-looking statement.
Factors that could exact or contribute to such variation include, but are not limited to, those grudge under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Immtech's annual report on Form 10-K for the year the end March 31, 2007 and in its other SEC filings and include: (i) Immtech's neatness to get it together commercially viable products; (ii) Immtech's ability to complete profitability; (iii) Immtech's ability to retain switch personnel; (iv) the ability of Immtech's scientists and collaborator to hit upon new compounds; (v) the availability of additional research compromise; (vi) Immtech's ability to get your hands on regulatory approbation of its drug candidate, including PCP; (vii) the glory of Immtech's clinical trial; (viii) enslavement upon and contractual bond with partner; (ix) Immtech's ability to invention or to have a third do manufacture its drug candidate at a plausible debt; (x) Immtech's ability to defend its academic wealth; (xi) combat and alternative technology; (xii) Immtech's ability to obtain colony from third party payers for any article of trade it commercializes; and (xiii) upcoming revealing to significant product liability.
Immtech Pharmaceuticals, Inc.
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