BUSINESS WIRE; Tuesday May 19, 7:32 am EST
The first study, reported in the Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, examined the use of activated cellular therapy in cats diagnosed with feline leukemia (FeLV), an incurable viral disease that closely models human HIV/AIDS. Eighteen FeLV-antigen-positive household cats had lymph nodes removed without complication. "Helper" T lymphocytes were taken from the lymph nodes, then activated and expanded in a laboratory. Sixteen cats received a single infusion of the newly expanded cells which was well tolerated, with only short-term fever occurring after the injection.
Clinical activity, antiviral activity or both were observed in ten of 16 cats. Nine cats had clinical responses with improvement in weight, activity, appearance or a combination of these that began two to four weeks after cell infusion and that lasted for 13 or more months. FeLV antigen became undetectable in four cats.
In the second study, appearing in AIDS Research and Human Retroviruses, scientists investigated whether HIV-specific, helper T lymphocytes could be expanded from the lymph nodes of patients with advanced HIV infection. In this preclinical lab study, lymph nodes were obtained from ten HIV-infected donors. Helper T cells were activated and expanded in vitro for up to 12 days. Cells expanded an average of 16-fold, indicating that a significant number of helper T cells can be produced in these short-term cultures, even when the cells are taken from the lymph nodes of patients with advanced disease.
The study also reported that, after one to three days, HIV levels as detected in the culture were increased, but by day six to nine, the HIV was undetectable. Target cells from the patients were modified in the laboratory to express particular "pieces" of the virus. The T cells responded to the target cells by expanding and secreting cytokines, and in particular, chemokines, which may play a role in blocking the entry of HIV into human cells.
"We believe these studies indicate that adoptive immunotherapy using lymph node cells that are activated and expanded in the laboratory in short-term cultures can regulate the course of retroviral infection," said Pierre L. Triozzi, M.D., the first author of both publications and a hematologist-oncologist at The Ohio State University, Columbus, Ohio. Dr. Triozzi and researchers at Ohio State pioneered the first clinical trial using the therapy in ten patients, with encouraging results that have been submitted for publication.
"These exciting results led to my collaboration with Neoprobe to begin a series of targeted clinical trials to further investigate this innovative cellular therapy," said Nancy Klimas, M.D., director of AIDS research, Miami VA Medical Center's AIDS Program and the South Florida VA Foundation for Research and Education, Inc., and professor of medicine, University of Miami School of Medicine, Miami, Fla. "Its low toxicity and overall immune restoration potential may make it a natural treatment candidate for patients with HIV/AIDS who are co-infected with other viruses."
Neoprobe has a research agreement with Dr. Klimas to conduct clinical and laboratory research using ACT for the treatment of patients with HIV/AIDS and other chronic viral diseases. She is currently enrolling patients in a Phase I trial to investigate the use of activated cellular therapy with patients co-infected with HIV/AIDS and chronic active hepatitis B or C.
"Although recent new anti-retroviral drug `cocktails' have greatly increased our capability to manage HIV/AIDS, we haven't yet found a way to eradicate it," said John L. Ridihalgh, Ph.D., Neoprobe chairman of the board and chief scientific officer. "An immune approach such as ours could complement today's pharmacological approach. This potential has compelled Neoprobe to pursue a series of small, cost effective clinical studies that will help us to quickly assess our activated cellular therapy."
Neoprobe Corporation is developing products intended to improve the standard of care, enhance the quality of life and extend survival for patients with cancer and other life-threatening diseases.
The statements made in this news release contain certain forward looking statements that involve a number of risks and uncertainties. Actual events or results may differ from Neoprobe's expectations. In addition to the matters described in this news release, ultimate timing and approval by FDA and other regulatory agencies, inherent uncertainties accompanying new product development and marketing, actions of government and private organizations concerning reimbursement, the impact of competitive products and pricing, the results of further clinical trials as well as the risk factors listed from time to time in Neoprobe's SEC filings, including but not limited to its annual report on Form 10-K for the year ended December 31, 1997, may affect the actual results achieved by Neoprobe.
Contact: Neoprobe Corporation David Bupp, Judy Barnes or Beth Gonda, 614/793-7500 jbarnes@neoprobe.com bgonda@neoprobe.com
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