If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Positive Results With NTZ for Cryptosporidial Diarrhea in AIDS Patients NEW ORLEANS, Sept. 18, 1996 -- Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) today announced that its new product, nitazoxanide (NTZ), showed positive results in treating cryptosporidial diarrhea, a potentially life-threatening complication of AIDS, in a Phase II study presented here at the Interscience Conference on Antimicrobial Agents and Chemotherapy. In addition, positive results also were observed in an ongoing nationwide compassionate use study. Condition Occurs in 15-20 Percent of AIDS Patients, Others Worldwide There is no consistently effective or approved therapy for cryptosporidiosis, caused by a microscopic protozoan parasite. Symptoms include profuse diarrhea, abdominal cramping, urgency, severe dehydration and weight loss. It is estimated that 15 to 20 percent of AIDS patients suffer from this condition. For them this diarrhea can be chronic, severe and often life threatening. In people with normal immune function, cryptosporidiosis may be intense and prolonged, but usually is self-limited, lasting up to two to four weeks. However, it is estimated that 45 million people in the U.S. may be exposed to drinking water from systems contaminated with "Cryptosporidium." In 1993, an outbreak in Milwaukee caused illness in 400,000 and was linked to at least 100 deaths. Studies Indicate NTZ Reduces Diarrheal Frequency, Helps Improve Weight The Phase II clinical trial included 28 patients with both AIDS and cryptosporidial diarrhea, who failed to respond to other therapies. These patients received up to 2,000 mg (milligrams) per day of NTZ for eight weeks. Results showed that 58 percent had a clinical response, with 50 percent having complete or partial reduction in bowel movement frequency, and 36 percent showing complete or partial reduction of cryptosporidial parasites. In addition, 32 percent of patients experienced reduction of both diarrhea and parasites. Dr. Rosemary Soave, assistant professor of medicine at Cornell University, was the lead investigator of the study conducted at New York Hospital - Cornell Medical Center and the Kaiser Foundation Research Institute in San Francisco. "NTZ appears to have a favorable clinical effect on cryptosporidial diarrhea, and greater benefit may be obtained with longer treatment times and/or higher doses," she explained. "In addition, the drug was well tolerated and patient compliance was excellent. The findings of this study suggest that NTZ may represent a significant advance in the treatment of cryptosporidial diarrhea." Interim results of an ongoing compassionate use study, in which access to NTZ was given to AIDS patients who failed to respond to other therapies, also were positive. NTZ was associated with a significant and progressive decrease in the frequency of bowel movements and liquid stools beginning at the end of the first week. By the eighth week, the mean total stool frequency in 113 patients who received 500 mg twice a day declined by 50 percent. Mean liquid stool frequency declined by 65 percent. Moreover, body weight in these patients increased by approximately one pound per week during eight weeks of therapy. Phase III Trial Planned "A Phase III study is planned to begin by year-end to more fully demonstrate the safety and effectiveness of NTZ," said Stephen Simes, Unimed president and CEO. "NTZ currently is approved for marketing in Mexico and has been designated an Orphan Drug by the U.S. Food and Drug Administration. We plan to submit results of the Phase III study to health authorities in the U.S. and other countries seeking approval to market NTZ as soon as they are available. This compound shows great promise for treating a condition where therapies are urgently needed. "NTZ is a nitrothiazole benzamide compound with activity against a number of protozoan and helminthic pathogens. Unimed holds an exclusive license to develop and market oral dosage formulations of NTZ for human use in the U.S., Canada, Australia and New Zealand from Romark Laboratories, L.C. in Tampa, Florida. NTZ has been sublicensed to BioChem Therapeutic Inc., the wholly-owned therapeutic subsidiary of BioChem Pharma (Nasdaq: BCHXF) for eventual marketing in Canada," Simes explained. Unimed Pharmaceuticals develops and markets niche pharmaceutical products for AIDS, endocrinology, urology and other therapeutic areas. The company also is growing through inlicensing niche marketed and late-stage development products.
|
