CHINESE SFDA GRANTS IMMTECH FAST TRACK STATUS.Immtech Pharmaceuticals, Inc. (Amex: IMM IMM See: International Monetary Market ) has announced that the State Food and Drug Administration The State Food and Drug Administration (SFDA Simplified Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration. of the People's Republic of China (SFDA) has granted Immtech's application Fast Track Status for conducting a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with pafuramidine, the company's oral drug candidate for the treatment of Pneumocystis pneumonia (PCP PCP abbr. 1. phencyclidine 2. primary care physician Pneumocystis carinii pneumonia (PCP) ). Pafuramidine is among the first drugs to be considered for Fast Track Status under new and more stringent SFDA rules recently introduced in China. The PCP clinical trial to be conducted in China will be under the US FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. protocol (www.sfda.gov.cn). Eric L. Sorkin, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Immtech stated, "This is a significant milestone for Immtech to work in China to accelerate the approval and availability of pafuramidine as a treatment for PCP. As the most populous nation in the world, China is well positioned to support and benefit from important efforts to combat PCP and other devastating infectious diseases." PCP is a fungal infection in the lungs and can cause potentially life-threatening pneumonia in patients with HIV and other immune-related diseases. An estimated one million adults and children are afflicted with PCP worldwide, and approximately five million more receive prophylaxis. PCP is one of the most common opportunistic infections in the estimated 42 million AIDS/HIV patients worldwide. There are only a few treatment options for PCP, and patient intolerance of current therapies is a significant problem. In addition, molecular evidence suggests that resistance of Pneumocystis Pneumocystis /Pneu·mo·cys·tis/ (-sis´tis) a genus of yeastlike fungi. P. cari´nii is the causative agent of interstitial plasma cell pneumonia. pneu·mo·cys·tis n. fungus to current therapy is increasing and may result in failure of treatment or prophylaxis. Pending approval to proceed by the Chinese regulatory authority, pafuramidine will be the first drug candidate to advance to clinical stage development in China for HIV related PCP. Carol Olson, MD, PhD, Immtech's Sr. vice president and chief medical officer, stated, "We are enthusiastic about the opportunity to conduct clinical trials in China. International collaboration will be an essential element in global efforts to treat infectious diseases, and we look forward to working closely with China's Centers for Disease Control and other health organizations to bring safe and effective drugs to market." In June 2007, Immtech entered into an exclusive licensing agreement with Par Pharmaceutical Companies, Inc. (NYSE NYSE See: New York Stock Exchange : PRX) under which Par will receive commercialization rights in the U.S. to pafuramidine for the treatment of PCP in AIDS patients. About Immtech Pharmaceuticals, Inc. Immtech Pharmaceuticals, Inc. is developing and commercializing drugs to treat infectious diseases. Immtech has advanced clinical programs that include new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis trypanosomiasis (trəpăn'əsōmī`əsis), infectious disease caused by a protozoan organism, the trypanosome, which exists as a parasite in the blood of a number of vertebrate hosts. (African sleeping sickness Af·ri·can sleeping sickness n. African trypanosomiasis. ), and a well defined, expanding library of compounds targeting Hepatitis C, fungal infections, and bacterial infections. Immtech holds exclusive worldwide licenses to certain patents, patent applications and technology for products derived from a proprietary pharmaceutical platform. For more information, visit http://www.immtechpharma.com or call 646/213-2822. About Par Pharmaceutical Companies, Inc. Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For more information, visit http://www.parpharm.com. |
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