YONKERS, N.Y., June 18 /PRNewswire-FirstCall/ --
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that
Product R, the Company's immunomodulator type drug, received approval from the
Israeli Ministry of Health for a Phase I clinical study for the treatment of
body wasting (cachexia) in patients with solid tumors. The Company believes
that this trial may assist the investigational new drug (IND) process with the
U.S. Food and Drug Administration (FDA).
"This approval for a Phase I study of the clinical use of the injectable
form of Product R represents an important occasion in the history of Advanced
Viral Research Corp. This marks the beginning of the rigorous scientific
investigation of the clinical use of systemically administered Product R,
required by the U.S. Food and Drug Administration (FDA)," stated Shalom Z.
Hirschman, M.D., Chief Executive Officer and President. "In this clinical
study, Product R will be investigated for its ability to treat the body
wasting that accompanies the growth of solid tumors such as colonic, lung,
breast, stomach and kidney cancers. Thus, this study is aimed at a wide
population of patients with solid tumors suffering with cachexia."
Cachexia is a state of body malnutrition and wasting with loss of lean
body weight. Cachexia can result from severe loss of appetite (anorexia) or a
metabolic derangement mediated by the cancer itself or the treatment. Studies
published in the medical literature indicate the following: In a palliative
care setting up to 85% of cancer patients may be afflicted with cancer or
treatment induced cachexia. Cachectic cancer patients have shortened
survivals. Data published in the medical literature indicate that cachexia
may account for up to 30% of cancer-related deaths.
"New and effective, non-toxic therapy is sorely needed for cancer patients
with cachexia," noted James T. D'Olimpio, M.D., Director of The North Shore
University Hospital's Supportive Oncology and Palliative Care Service and
Associate Professor of Medical Oncology at New York University's School of
Medicine. "Supporting patients during chemotherapy has become a major
imperative to the oncologic community. Cachexia is a multifactorial process
that leads to loss of lean body mass or muscle tissue. It is critically
important to find new treatments that mitigate chemotherapeutic effects,
maintain a patient's immune system, and prevent weight loss. The potential
for Product R to influence cachexia in a positive way demands clinical
investigation." Dr. D'Olimpio is an expert in the treatment of cachexia and
conducts research in this field. He is a member of the Company's Scientific
Advisory Board.
Solid tumors are prevalent cancers in the population of the United States.
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 in the U.S. in the year 2002. Of these
solid tumors female breast, colorectal, lung and bronchus and prostate cancers
will cause an estimated total of 281,300 deaths in the U.S. in the year 2002.
In this Phase I trial, in addition to the primary objective of determining
the safety and toxicity profile of Product R in this population of cancer
patients, secondary objectives include observations on effects of Product R in
treating and mitigating cachexia and lastly on possible responses in treating
the tumor itself. The trial will be conducted as a Phase I dose escalation
study preceded by a pre-Phase 1 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 site for this study is the Chaim Sheba Medical Center in Tel
Hashomer, Israel. The protocol for this trial was designed by medical
researchers at the Selikoff Center for Environmental Health and Human
Development in Israel 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 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.
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 Information:
Mayr Communications, Inc.
877-777-6010
mayrcomm@att.net
SOURCE Advanced Viral Research Corp.
 back to top
Related links:
http://www.adviral.com
CONTACT:
Mayr Communications, Inc., +1-877-777-6010,
mayrcomm@att.net, for Advanced Viral Research Corp.
|
