Findings Presented at Meeting of the American Association for Cancer Research
Show That Product R Induces Differentiation of a Human Promyelocytic Leukemia
Cell Line
YONKERS, N.Y., Oct. 11 /PRNewswire-FirstCall/ --
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that
the Company's peptide nucleic-acid immunomodulator, Product R, induces
differentiation of the human promyelocytic leukemia cell line HL-60 in cell
culture. These research findings are being presented today at a conference of
the American Association for Cancer Research (AACR) entitled, "Proteases,
Extracellular Matrix and Cancer", held in Hilton Head Island, South Carolina.
A prime property of cancers cells, such as leukemia cells, is that they
exhibit undisciplined or "wild" growth patterns. Cancer cells are often
termed as being "undifferentiated." Normal or "differentiated" cells exhibit
orderly growth patterns, subject to the normal controls of cellular growth.
Drugs that induce cellular differentiation and maturation, such as tretinoin,
currently are utilized to treat promyelocytic leukemia.
"These exciting research findings suggest the potential of new cancer
treatments with Product R. Moreover, these findings complement our clinical
trial in Israel of Product R in patients with hematopoietic cancers," said
Shalom Z. Hirschman, M.D., President and CEO of Advanced Viral Research Corp.
"The use of targeted agents to induce the differentiation of cancer
cells -- that is, to reverse the unruly growth of cancer cells -- is a
relatively new field of cancer therapy with a growing market. These new
research results indicate that Product R should be studied clinically for
utilization in this type of cancer therapy."
"Our teams of scientists continue to produce research results that point
to new potential therapeutic uses of Product R," stated Mr. Eli Wilner,
Chairman of the Board of Advanced Viral Research Corp. "These results expand
the horizons of Product R in cancer therapy."
To determine whether Product R induces differentiation of promyelocytic
leukemia cells, scientists at Advanced Viral Research Corp. tested the effects
of this drug on HL-60 cells, a promyelocytic leukemia cell line that has the
ability to differentiate toward granulocytes or monocytes in cell culture.
When undifferentiated HL-60 cells were cultured in the presence of Product R,
it was found that Product R inhibited cell growth and induced cell
differentiation, as measured by the expression of characteristic cell surface
markers of cellular differentiation such as CD-14 and CD-35. Product R also
stimulated the expression of other markers of cellular differentiation,
resulting in functionally more mature cells.
Product R Clinical Studies
Phase II U.S. Study
In 2001, ADVR submitted to the FDA an IND for the topical treatment of
genital warts, and a Phase I safety study has been completed successfully in
healthy volunteers with the current liquid formulation. In April 2002, the
Company announced that it had submitted to the FDA the results of this Phase I
trial, and that the FDA had made no adverse comments concerning the Phase I
results. The Company is now beginning the process of recruiting clinical
sites in the United States to perform Phase II clinical trials with Product R
in patients with genital warts. During the course of Phase II, the efficacy
of Product R for the topical therapy of genital warts will be investigated in
various doses. Due to limited financial resources, the Company has not yet
secured clinical sites nor has it made any material progress on the Phase II
clinical trials.
Israeli Clinical Studies
In June 2002, ADVR announced that it had received approval from the
Ministry of Health for three clinical studies in Israel. The three trials
include a Phase I/Phase II clinical trial with injectable Product R in
cachectic AIDS 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 in cachectic 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 recently secured funds to
commence these clinical trials; however, additional financing to continue or
complete subsequent clinical trials may not be available to us, which may
force us to curtail our operations by, among other things, limiting our
clinical trials for Product R.
Recent Appointment
Advanced Viral Research Corp. recently announced the appointment of Dr.
Richard S. Kent to the Board of Directors. Dr. Kent was previously Senior
Vice President of Global Medical Affairs and Chief Medical Officer for
GlaxoSmithKline (NYSE: GSK). Dr. Kent brings nearly two decades of global
pharmaceutical industry experience to the Company.
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.
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.
CONTACT:
Charles Mayr
Mayr Communications, Inc.
877-777-6010
mayrcomm@att.net
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SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
CONTACT:
Charles Mayr of Mayr Communications, Inc.,
+1-877-777-6010, or mayrcomm@att.net, for Advanced Viral Research
Corp.
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