Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - December 12, 2002
"Initial excitement about the potential of Product R as an anti-HIV medication came about when it was shown to inhibit HIV in cell cultures as well as stimulate proinflammatory chemokines, small proteins produced by the immune system cells in response to viral, among other infections," Dr. Shalom Z. Hirschman, President and CEO of ADVR told the publication.
The A&U story noted that the potential of Product R was evident in the results of a clinical study, published in the July/August 2002 issue of HIV Clinical Trials. In this trial, 43 antiretroviral naive patients were studied, 21 of whom received Product R through subcutaneous injection. "Even with this small study, in a short-term, the statistical power of the rise in CD4 cell counts and the rise in weight in the treated patients was really remarkable," said Dr. Hirschman. "There were also trends toward rises in the CD8 counts and the lowering of the viral loads."
The article noted that the Israeli trials, which are now underway, will look at "Product R's treatment and reversal of body wasting, and, more significantly, as a salvage therapy for patients who have not benefited from or cannot tolerate HAART." The story went on to note that the Company "would like to see Product R become one of the 'anchor' drugs in HIV/AIDS treatment, enabling patients to tolerate HAART longer and improve their quality of life."
On November 14th, the Company announced that it had initiated the single- dose safety study which is the first phase of three Product R clinical trials in Israel. The three clinical trials include:
* a Phase I/II clinical trial with injectable Product R in cachectic patients who have failed highly active antiretroviral therapy and require salvage therapy;
* a Phase I clinical study for the treatment of body wasting (cachexia) in patients with solid tumors; and
* a Phase I clinical trial for cachectic patients with hematopoietic and lymphoid tumors, including acute lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma.
As the Company noted in announcing the initiation of the trials, "ADVR continues to make significant progress in the development of Product R. We plan to build on these clinical trials so as to increase the potential clinical applications of Product R as an innovative and safe therapeutic agent and we remain committed to developing Product R as efficiently as possible for the treatment of diseases that represent potentially significant market opportunities."
Additional information about the Israeli clinical trials is available in the President's Progress Report for December 2002, posted on the Company's web site at http://www.adviral.com.
Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases.
Access to the A&U website and the text of the study are available at http://www.aumag.org.
Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. Product R is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of Product R or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Contact: Charles Mayr, Mayr Communications Inc
877-777-6010
mayrcomm@att.net
SOURCE Advanced Viral Research Corporation
Web Site: http://www.adviral.com
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