Business Wire - November 29, 2001
The Phase Ia study, conducted in 13 subjects suffering from HIV/AIDS, found Cytolin(R) to be safe and well tolerated across a narrow dose range. The initial safety study, which consisted of two single escalating doses of 0.05mg and 0.1mg/kg body weight, affirmed the safety and tolerability of the drug in these lower dose groups with no serious or severe adverse events reported.
"We are pleased with the continuing progress of Cytolin(R) in the clinical setting," said Donald W. Northfelt, M.D., F.A.C.P., Assistant Clinical Professor of Medicine at the University of California, San Diego and principal investigator for the Phase Ia trial. "We look forward to examining safety results at higher dose levels and, ultimately, generating efficacy data."
About Cytolin(R)
Cytolin(R) is a patented monoclonal antibody that blocks certain adhesion molecules on one of the disease-fighting cells of the immune system, thereby protecting the immune system from "killer-type" T cells that tend to turn the human immune system against itself.
By helping to shore up the immune system's natural defenses, Cytolin(R) is a distinctly different therapeutic approach from antiviral drugs (e.g., reverse transcriptase inhibitors and protease inhibitors), which take the offensive against the virus.
Amerimmune is engaged in pharmaceutical research and development with the primary purpose of developing Cytolin(R), a drug designed to protect the immune system, especially in patients suffering from human immunodeficiency virus (HIV).
The company believes that Cytolin(R) is an important drug for the growing number of patients who have not been receiving treatment, for those who are on multi-drug therapy and for those who have become resistant to drugs currently used to treat the HIV/AIDS virus.
For more information, visit the company's Web site, www.amerimmune.com.
Statements made in this news release that are not historical facts, such as anticipated results of clinical trials, may constitute "forward-looking statements," which are made pursuant to the safe harbor provisions in the federal securities laws. Forward-looking statements are subject to risks, uncertainties and other factors beyond the control of the company that could cause actual results to differ materially from those from those set forth in, contemplated by, or underlying the forward-looking statements. Factors that could cause actual results to differ materially from the company's expectations are detailed in the company's filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K. The company disclaims any obligation to revise any forward-looking statements to reflect events or circumstances after the date of such statement or to reflect the occurrence of anticipated or unanticipated events.
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