Progress of Current AIDS Trial Leading Selikoff Center to Develop Protocols
For Multi-Center, Blinded Controlled Trial
YONKERS, N.Y., March 18 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced that, in consultation with
the Selikoff Center, it has initiated activities necessary to expand the
ongoing Israeli clinical trial of Product R for the treatment of AIDS patients
on highly active antiretroviral therapy (HAART). The Company said it has
directed the staff of the Selikoff Center in Israel, in collaboration with the
principal investigator, to begin developing protocols for a multi-center, late
stage Phase II clinical trial of Product R in AIDS patients who are in need of
salvage therapy.
ADVR said the expanded trial is proposed to be a blinded, controlled trial
of Product R in at least 200 patients, including 50 patients in the control
group.
"The planned expansion of the current trial into a late stage Phase II
study is based on the gratifying progress of the current trial in patients
with AIDS and the confidence of the clinical investigators in Product R,"
stated Shalom Z. Hirschman, M.D., President and CEO of ADVR. "I am pleased
that the staff at the Selikoff Center and the principal investigator are
willing to begin a late Phase II trial as soon as the current clinical trial
is completed. By taking these steps now, we will be able to move as rapidly
as possible into the next phase of the clinical development of Product R."
"We are excited about accelerating our clinical study activities," said
Eli Wilner, Chairman of the Board of ADVR. "The completion of the current
trials, and the expansion of our activities into a late Phase II comparative
trial, move us closer to the ultimate goal of potentially commercializing
Product R for illnesses that are inadequately addressed by currently marketed
therapies."
Currently, the Selikoff Center is conducting a Phase I/II dose escalation
clinical trial of Product R in patients with AIDS. The dosages to be used in
the late Phase II clinical trial will be based on the final results of the
current clinical trial.
Status of Clinical Trials in Israel
Four medical centers in Israel are now participating in various stages of
the three ongoing clinical trials with Product R. Product R is undergoing
rigorous clinical testing that primarily should reveal its safety profile and
also some of its effects on cachexia in patients with AIDS and patients with
cancer, including the effects of Product R on the underlying cancers
themselves.
Phase I/II study in Cachectic Patients Needing Salvage Therapy for AIDS
This clinical trial, a Phase I/Phase II dose escalation study, is being
conducted at the Kaplan Medical Center in Rehovot, Israel. In order to
preclude problems with patient compliance, that would potentially harm
interpretation of clinical data, research nurses go to patients' homes to
inject the study patients with Product R six days a week and to conduct
clinical interviews with those patients.
Study of Treatment of Cachexia (Body Wasting) with Product R in Patients
with Solid Tumors
This clinical trial is a Phase I dose escalation study preceded by a
pre-Phase I single dose safety study. The trial is being conducted at the
Chaim Sheba Medical Center in Tel Hashomer, Israel as the principal trial
center with a partner center at the Beilinson Campus of the Rabin Medical
Center in Petach Tikva, Israel.
Study of Treatment of Cachexia with Product R in Patients with
Hematopoietic Cancers
The objective of this Phase I dose escalation trial is to study the safety
of Product R as a treatment of cachexia in patients with hematopoietic
cancers, including acute lymphocytic leukemia, multiple myeloma, Hodgkin's
disease or non-Hodgkin's lymphoma. The trial also will observe the effects of
Product R on the cancers themselves. The principal center for this trial is
the Hadassah Medical Center of the Hebrew University School of Medicine in Ein
Kerem, Jerusalem with a partner site at the Chaim Sheba Medical Center.
The Company currently is attempting to procure the financial resources
necessary to both complete the ongoing trials in Israel as well as to pursue
the proposed expanded clinical trial.
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
877-777-6010
MayrComm@att.net
SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
CONTACT:
Charles Mayr of Mayr Communications,
+1-877-777-6010, mayrcomm@att.net, for Advanced Viral Research
Corp.
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