YONKERS, N.Y., Nov. 14 /PRNewswire-FirstCall/ --
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that
it has initiated the single dose safety study which is the first phase of
three Product R clinical trials in Israel. The Company also announced that it
has retained Quintiles Transnational Corp.'s (Nasdaq: QTRN) Israeli unit to
independently monitor and audit the clinical trials according to U.S. Food and
Drug Administration (FDA) standards. ADVR has entered into an agreement with
EnviroGene, LLC, an affiliate of the Selikoff Center for Environmental Health
and Human Development in Israel, to conduct the clinical trials. The lots of
Product R for use in the clinical trials were produced following U.S. FDA cGMP
regulations in ADVR's plant in Yonkers, N.Y.
"These clinical trials are designed with the ultimate objective of moving
Product R into clinical use as quickly as possible," said Shalom Z. Hirschman,
M.D., President and CEO of Advanced Viral Research Corp. "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."
"We are very pleased to have retained the Israeli unit of Quintiles, a
leading contract research organization, to monitor and audit the clinical
trials. ADVR now is focusing its scientific staff and fiscal resources on
moving Product R through the proper clinical trials needed to ultimately bring
Product R into the pharmaceutical marketplace," Dr. Hirschman added.
"I am gratified that the clinical trials in Israel are under way. We look
forward to these trials assessing the effects of Product R as a new drug
candidate for the U.S. FDA and worldwide regulatory agencies," said Eli
Wilner, Chairman of the Board. "With the recently announced staff reductions,
and our announced intent to sell our Freeport, Bahamas, facility, we have
taken steps to streamline the Company and focus our resources on the objective
of undertaking these important trials. We are committed to developing Product
R as efficiently as possible for the treatment of diseases that represent
potentially significant market opportunities."
Overview of Israeli Clinical Studies
Phase I/II Study In Cachectic Patients Needing Salvage Therapy For 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 clinical study protocol was designed by medical researchers at the
Selikoff Center for Environmental Health and Human Development in
collaboration with the principal investigator, Professor Zev Shtoeger, and
staff members of the Company's FDA consultants, Globomax, LLC. The clinical
trial will be based at The Kaplan Medical Center that serves as a clinical
facility for the School of Medicine of The Hebrew University.
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. and that there were 15,245 AIDS related deaths in the
U.S. in 2000. The National Institutes of Health (NIH) estimates that 40
million people worldwide were living with HIV/AIDS at the end of 2001. The
CDC estimate that at least 20% of patients do not respond to HAART or cannot
tolerate the drugs that make up HAART regimens.
Phase I Study In Cachectic Patients with Solid Tumors
In this Phase I trial, objectives include observations on the effects of
Product R in treating and mitigating cachexia and possible responses in
treating the tumor itself. The trial will be conducted as a Phase I dose
escalation study preceded by a pre-Phase I single injection study. The
clinical trial will be conducted in patients aged 18 years or older with
advanced stage malignancies not amenable to curative or life prolonging
therapy, manifesting body wasting (cachexia) as defined by a greater than 10%
involuntary weight loss over the prior six months.
The principal sites for this study are the Chaim Sheba Medical Center in
Tel Hashomer, Israel, and the Rabin Medical Center (Beilinson Campus) in
Petach Tikvah, Israel. The protocol for this trial was designed by medical
researchers at the Selikoff Center in collaboration with the principal
investigator, Dr. Rony Weitzen, Acting Head of Day Care Unit, Institute of
Oncology, the Chaim Sheba Medical Center, and staff members of Globomax, LLC.
The American Cancer Society estimates that female breast, colorectal, lung
and bronchus, prostate and urinary bladder cancers will account for a total of
766,700 new cases of solid tumors and 281,300 deaths in the U.S. in the year
2002.
Phase I Study in Cachectic Leukemia and Lymphoma Patients
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 for the trial is Professor Dina Ben Yehuda, the
Chairperson of Hematology at the world renowned Hadassah Medical Center of The
Hebrew University, in collaboration with Professor Arnon Nagler, the
Chairperson of the Hemotology Institute of the Chaim Sheba Medical Center at
Tel Hashomer, Israel. The protocol for the trial was designed by medical
researchers at the Selikoff Center in collaboration with Professor Dina Ben
Yehuda and staff members of Globomax, LLC.
The American Cancer Society estimates that 60,900 new cases of lymphoma
will occur in the U.S. in the year 2002, comprising 7,000 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 that 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.
Product R
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.
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.
MAYR COMMUNICATIONS INC
CONTACT: CHARLES MAYR
TEL: 877.777.6010
MAYRCOMM@ATT.NET
SOURCE Advanced Viral Research Corp.
 back to top
Related links:
http://www.adviral.com
CONTACT:
Charles Mayr, Mayr Communications Inc,
+1-877-777-6010, mayrcomm@att.net, for Advanced Viral Research
Corp.
|
