Business Wire - March 6, 2000
Amerimmune reported that infusion of the first cohort of patients has begun, following successful recruitment of subjects who meet the trial's rigorous inclusion criteria.
The fundamental goal of the trial remains to evaluate the safety, potential benefits, and biological effects of various doses of the drug.
The new principal investigator for the trial is Donald W. Northfelt, M.D., F.A.C.P. Dr. Northfelt has been an Assistant Clinical Professor of Medicine in the AIDS Clinic at University of California, San Diego since 1996 and has held faculty positions in HIV/AIDS and Hematology/Oncology at University California, San Francisco, and at the AIDS Clinic at San Francisco General Hospital.
The Cytolin trial is being conducted in Dr. Northfelt's research facility at Eisenhower Medical Center in Rancho Mirage, Calif.
"Dr. Northfelt is an outstanding clinician with extensive experience as an HIV/AIDS specialist and is an ideal lead investigator for the trial. Furthermore, his extensive patient base contains subjects who meet the inclusion criteria of the study," said Rex H. Lewis, president and chief executive officer of Amerimmune.
Amerimmune reported that the company's ongoing extensive patient recruitment campaign in the Palm Springs area consists of direct patient outreach and local television appearances and print stories featuring representatives of the company. Dr. Northfelt is spearheading this local effort with the support of Tom Bianchi, a well-known photographer/author who was one of the first patients to receive Cytolin therapy.
"Tom is working closely with Pam Kapustay, Amerimmune's vice president of operations, to maximize the visibility of the study and attract a broad potential patient population," added Lewis. "For example, on March 4 Amerimmune sponsored a well-attended reception in Palm Springs to raise awareness about Cytolin in the community at large and identify potential patients now and for prospective future studies."
Other Developments
Amerimmune announced the appointment of Deborah Garrett Kalof, CPA, as chief financial officer. Kalof replaces Wellington Ewen, who has left the company to pursue other opportunities. Kalof, who holds B.S. and M.B.A. degrees from the University of Florida, Gainesville, has extensive accounting, reporting and financial management experience with both domestic and multinational firms, including Bastion Capital Fund LP, and Westfield Corporation Inc.
Amerimmune also reported the resignations of Daniel L. Azarnoff, M.D. and Roy S. Azarnoff from the company's Board of Directors and the resignation of Roy S. Azarnoff as secretary/treasurer of the company.
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 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, a drug designed to protect the immune system, especially in patients suffering from human immunodeficiency virus (HIV). The company believes that Cytolin 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, http://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 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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