YONKERS, N.Y., June 6 /PRNewswire-FirstCall/ --
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that
its antiviral immunomodulator, Product R, was approved by the Israeli Ministry
of Health for Phase I/II clinical trials in patients who have failed highly
active anti-retroviral therapy (HAART) and require salvage therapy. The
Company anticipates that these clinical trials will help facilitate the
investigational new drug (IND) application process for Product R with the U.S.
Food and Drug Administration (FDA).
"The approval by the Israeli Ministry of Health for the Phase I/II studies
of the injectable form of Product R is a milestone in our objective to
ultimately establish Product R as an anchor drug for the treatment of patients
with AIDS," commented Shalom Z. Hirschman, M.D., President and Chief Executive
Officer of Advanced Viral Research Corp. "Product R will be put to rigorous
scientific tests as a therapy for patients with AIDS, including patients who
have failed HAART."
"We believe that Product R may have three major beneficial effects in
patients with AIDS. First, Product R is being studied for its therapeutic
effects on the body wasting (cachexia) seen in patients with AIDS," Dr.
Hirschman continued. "Second, Product R appears to mitigate the toxicity of
drugs included in HAART regimens for the treatment of AIDS. Third, Product R
appears to act synergistically with the drugs used in HAART regimens to
suppress the replication of HIV and increase the CD4 and CD8 cell counts in
patients with AIDS. Thus, Product R may prove to be an important "enabler"
drug in the treatment of AIDS."
The Phase I segment of these clinical trials is a dose escalation study
designed to determine the safety and toxicity profile of Product R. The study
also will determine the effect of Product R on AIDS related wasting
(cachexia). The possible salvage effects of Product R in these patients will
be investigated as well. The study population will be composed of patients
aged 18 years or older who have received maintenance anti-retroviral therapy
for at least one month prior to entry into the study. The patients will have
experienced involuntary weight loss of greater than 10% of pre-morbid body
weight during the prior six months.
The protocol was designed by medical researchers at the Selikoff Center
for Environmental Health and Human Development in collaboration with the
Principal Investigator, Professor Z. Bentwich, a world leader in clinical AIDS
research and director of the largest AIDS center in Israel and staff members
of the Company's FDA consultants, Globomax, LLC. The clinical trial will be
based at The Barzilai and Kaplan Medical Centers that serve as clinical
facilities for the Faculty of Health Sciences of both Ben Gurion University
and The Hebrew University. The Company is currently in the process of raising
the funds necessary to commence the clinical trials.
The Centers for Disease Control and Prevention (CDC) estimate a prevalence
of 850,000 to 950,000 patients in the U.S. with HIV infection. The CDC
further estimate that approximately 40,000 persons are newly infected with HIV
each year in the U.S. There were 15,245 AIDS related deaths in the U.S. in
the year 2000, according to the CDC.
The National Institutes of Health (NIH) cite figures indicating that one
in every 100 adults aged 15 to 49 is infected with HIV worldwide. At the end
of the year 2001, it was estimated by the NIH that 40 million people worldwide
were living with HIV/AIDS.
The incidence of HIV infection and AIDS continues to increase worldwide.
The CDC estimate that at least 20% of patients do not respond to HAART or can
not tolerate the drugs that make up HAART regimens. Moreover, according to
the CDC, most patients experience some side effect from the HAART drug
regimens.
The Company believes that new "enabling" drugs -- that is, drugs that
allow the patient to better tolerate the drugs that constitute HAART regimens
and also increase the therapeutic activities of HAART drug regimens -- are
greatly needed to improve the therapy and quality of life of patients with
AIDS.
Product R is being investigated as a non-toxic peptide-nucleic acid-type
immunomodulator that 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.
For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.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.
SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
CONTACT:
Mayr Communications, Inc., +1-877-777-6010,
or mayrcomm@att.net, for Advanced Viral Research
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