Study Concludes Product R Patients Had Increased CD-4 Cell Counts and Weight
Gains Compared to Placebo Patients
YONKERS, N.Y., Aug. 20 /PRNewswire-FirstCall/ --
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that
the results of a randomized, controlled and blinded clinical study of Product
R therapy in patients with HIV/AIDS have been published in the July/August
2002 issue of HIV Clinical Trials. This international, peer-reviewed
scientific journal is devoted to disseminating reports of original clinical
trials in HIV/AIDS patients. The now published clinical trial was designed to
determine the safety and efficacy of Product R in treating HIV-infected
patients.
Patients treated with Product R during the trial showed statistically
significant increases of CD4 positive cell counts and weight gain. In
addition, there was a trend towards decreased numbers and severity of
opportunistic infections and decreased HIV viral loads in the Product R
treated patients. The authors noted, however, that there is need for "larger
clinical studies to assess the efficacy of the drug at various clinical time
points during the course of HIV infection and to determine the optimum dosage
regimen and duration of treatment with Product R."
"Product R effected a statistically significant increase in CD4 positive
lymphocytes and weight gain in the treated patients, drawn from a population
of patients that previously had never been treated with other drugs. There is
an urgent need for new therapies that act adjunctively with antiretroviral
agents to enhance the efficacy and tolerability of the drugs that make up
highly active antiretroviral therapy regimens," said Shalom Z. Hirschman,
M.D., President and CEO of Advanced Viral Research Corp. "We hope to extend
the results of this published study in future clinical trials, including those
that we are preparing to initiate in Israel. In those trials, we will examine
the efficacy of Product R in treating patients who have failed highly active
antiretroviral therapy and require salvage therapy, and the effects of Product
R on AIDS-related body wasting."
"We are pleased that this paper has been published in a peer-reviewed
journal that focuses on the critical need for developing more effective AIDS
therapies," said Eli Wilner, ADVR Chairman. "We are hopeful that future
clinical trials will support the Company's objective of eventually
establishing Product R as an anchor drug in the treatment of AIDS."
Study Design
The study, entitled "A Randomized, Placebo-Controlled Trial of Product R,
a Peptide-Nucleic Acid Immunomodulator, in the Treatment of Adults Infected
with HIV" was conducted in 1996 at the University of West Indies School of
Clinical Medicine and Research, Queen Elizabeth Hospital, in Bridgetown,
Barbados.
The study protocol was reviewed and approved by a committee chaired by the
Chief Medical Officer, Ministry of Health and the Environment, Barbados.
Patients were recruited if they had a diagnosis of HIV infection, as confirmed
by two different enzyme-linked immunoabsorbent assays (ELISAs) or by one ELISA
and a Western blot, and if they had not previously received antiretroviral
therapy. Patients were excluded if they were co-infected with any form of
hepatitis virus.
The clinical study enrolled 43 HIV-infected adults naive to anti-
retroviral therapy. A total of 21 patients received Product R, and 22
patients received the placebo. Both physicians and patients were blinded to
treatment assignment.
The dosage was two 1ml subcutaneous injections daily on the first 14 days,
followed by one daily 1ml dose on days 22-28, 36-42 and 50-56. The follow up
period lasted until day 120. At the end of the follow up period, there was a
statistically significant increase in CD4 positive cell counts (p=.014) in the
Product R treated patients. The Product R group experienced a mean weight
increase (p = .003) while the placebo group experienced a mean weight loss.
No toxic effects were observed in any of the patients who received Product R.
There was a trend towards higher CD8 cell counts, lower viral loads and fewer
opportunistic infections in the product R treated group.
The paper published in HIV Clinical Trials was authored by
Paul N. Levett, PhD, Shalom Z. Hirschman, MD, Timothy C. Roach, MD, Hedy
Broome, PhD, Richard J. Alexander, PhD, and Henry S. Fraser, MD, PhD. A
summary of the results of the study were initially presented at the 98th
Annual Meeting of the American Society for Microbiology in Atlanta, Georgia,
May 1998. The study was supported by Advanced Viral Research Corporation.
The CDC estimates that more than 800,000 - 900,000 persons are living with
HIV infection or AIDS in the United States, that more than 20,000 new cases
are diagnosed each year, and that approximately 17,000 persons die annually of
the disease in the United States. Recent reports indicate that the virus
mutates and becomes resistant to highly active antiretroviral therapy
treatment, and side effects of HAART can lead to non-compliance.
Israeli Injectable Clinical Studies
In June 2002, ADVR announced that it had received approval from the
Ministry of Health in Israel for Phase I/II clinical trials with injectable
Product R in 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 patients with hematopoietic and lymphoid tumors, including acute
lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, who also
manifest symptoms of cachexia. The Company intends to initiate the studies
once adequate funding has been secured.
ADVR's Product R represents a biopolymer chemistry that possesses novel
immunomodulator activity. This peptide-nucleic acid, which to date has shown
no indication of human toxicity, appears to stimulate the proinflammatory
responses required to combat viral infections such as AIDS and human papilloma
virus and to dampen aberrant autoimmune-type inflammatory responses, such as
occur in patients with rheumatoid arthritis. Therefore, Product R has been
termed a "switch type" immunomodulator.
Product R is also being studied for the promise shown in its ability to
mitigate the toxic side effects of other drugs, including those used to treat
HIV infection and chemotherapeutic drugs employed in the treatment of cancers.
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 HIV Clinical Trials website and the text of the study is
available at http://www.thomasland.com.
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.
Mayr Communications
Contact: Charles Mayr
Tel: 877.777.6010
MayrComm@att.net
SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
http://www.thomasland.com
CONTACT:
Charles Mayr of Mayr Communications,
+877-777-6010, or MayrComm@att.net, for Advanced Viral Research
Corp.
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