Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - 27 December 1995
The U.S. Phase II clinical trial is being conducted at Cornell Medical Center in New York City under the direction of Dr. Rosemary Soave, Department of Infectious Disease, an internationally known cryptosporidium expert. Patients currently are being recruited for the study. The results are expected in the first half of 1996. If the findings are as positive as seen to date in AIDS patients, Unimed intends to begin a Phase III clinical trial shortly afterwards.
In addition to the ongoing Phase II clinical trial, the FDA has allowed expanded access to NTZ for AIDS patients suffering from cryptosporidium. The FDA action provides an open-label Compassionate Use protocol and expands access to the drug to patients who do not qualify for the controlled clinical trial. The data produced in the Compassionate Use protocol also will be available as supportive once a submission for approval is made with the FDA.
Unimed estimates that about 15-20 percent of AIDS patients suffer from cryptosporidium. While this gastrointestinal parasite causes temporary diarrhea in those with competent immune systems, it may result in profound chronic diarrhea in AIDS patients. There currently is no approved therapy to treat cryptosporidium.
NTZ Shown Safe and Effective in Studies Outside U.S.
President and Chief Executive Officer Stephen M. Simes stated, "NTZ is an important product for Unimed. Our initial focus will be developing NTZ for AIDS patients suffering from cryptosporidium infection. Preliminary work in AIDS patients has shown it to be safe and effective. To date, NTZ has been tested in over 1,000 patients outside the U.S. and has been shown to be safe and effective in a variety of gastrointestinal infections. We look forward to the results of the ongoing clinical trial in order to begin our Phase III clinical trial in 1996."
Cryptosporidium parvum is a protozoan: a waterborne microscopic parasite first identified in humans in the late 1970s. It attaches itself to intestinal cells and causes profuse watery diarrhea. In healthy people, it is self-limited and usually is not life threatening. However, in the immune-compromised patient, such as an AIDS sufferer, it can last for weeks or months and cause severe dehydration, weight loss, and even eventual death. Cryptosporidium is one of the most common opportunistic parasites in HIV-infected patients. It is spread by coming in contact with contaminated food or water, or the stool of an infected person (including sexual contact) or animal. In 1993, an outbreak of cryptosporidium in Milwaukee caused sickness in over 400,000 people. At least 100 deaths were linked to that outbreak. Estimates are that 45 million people in the U.S. may be exposed to drinking water from systems contaminated with cryptosporidium.
NTZ Fits Unimed Focus on AIDS
Unimed has rights to NTZ for the U.S., Canada, Australia, and New Zealand. "The product fits well with Unimed's current marketing of Marinol(R) (dronabinol) as an appetite stimulant in AIDS patients and with our intent to develop a newly licensed testosterone gel (Androgel(R)-DHT) for HIV wasting syndrome," said Simes.
Unimed Pharmaceuticals, Inc. develops and markets niche pharmaceutical products, with the AIDS market currently representing about 75 percent of revenues. The company is growing through in- licensing of other niche marketed and late-stage development products.
CONTACT: Stephen M. Simes, Pres. & CEO, of Unimed, 708-541-2525/ 11:23 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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