YONKERS, N.Y., June 12 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced that its immunomodulator-type
drug, Product R, has been approved by the supreme medical ethics committee
(Helsinki Committee) of the Ministry of Health in Israel for a Phase I
clinical trial. The trial will study the treatment with injectable Product R
of patients with hematopoietic and lymphoid tumors, including acute
lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, who also
manifest symptoms of cachexia, that is, severe weight loss and body wasting.
This trial may assist the Company in the investigational new drug (IND)
application process with the U.S. Food and Drug Administration (FDA).
"This is a significant event in the development program of Product R,"
stated Shalom Z. Hirschman, M.D., Chief Executive Officer and President of
Advanced Viral Research Corp. "This clinical trial will focus on the safety
and toxicity profile of Product R, but will also permit assessment of effects
of Product R on acute lymphocytic leukemia, Hodgkin's disease and
non-Hodgkin's lymphoma. We are especially excited to study, not only the
effects of Product R on body wasting (cachexia) in this group of patients but,
based on preliminary results, we also want to investigate whether Product R
has direct therapeutic effects on the cancers."
The American Cancer Society estimates that 60,900 new cases of lymphoma
will occur in the U.S. in the year 2002, comprising 7000 cases of Hodgkin's
disease and 53,900 cases of non-Hodgkin's lymphoma. These cancers are
estimated to cause a total of 25,800 deaths in the U.S. in the year 2002. It
is estimated the 30,800 new cases of leukemia will occur in the U.S. in 2002
and that 21,700 patients will die with leukemia in 2002.
Cachexia, with loss of lean body mass, is a debilitating consequence of
leukemias and lymphomas and their chemotherapy. Data from the medical
literature indicate that cachectic patients are more apt to die and that
cachexia accounts for up to 30% of cancer related deaths. The Company
believes that new and effective therapy is sorely needed for cachectic
patients with leukemias and lymphomas.
The objective of the trial is to determine the safety and toxicity profile
of Product R in a population of patients with advanced stage hematopoietic and
lymphoid malignancies not amenable to curative or life prolonging therapy who
manifest cachexia (body wasting). The study will emphasize the population of
patients with acute lymphocytic leukemia, Hodgkin's or non-Hodgkin's lymphoma.
The principal investigator of the trial is Professor Dina Ben Yehuda, the
Chairperson of Hematology at the world renowned Hadassah Medical Center of The
Hebrew University. The protocol for the trial was designed by medical
researchers at the Selikoff Center for Environmental Health and Human
Development in collaboration with Professor Dina Ben Yehuda and staff members
of the Company's FDA consultants, Globomax, LLC. The Company is currently
attempting to raise the funds necessary to commence the clinical trials.
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.
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.
For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.com .
SOURCE Advanced Viral Research Corp.
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