Patients Show Improved Appetite, Weight Stability or Gains,
and Enhanced Quality of Life
YONKERS, N.Y., Nov. 10 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today reported that preliminary results from
the first 15 cachectic (wasting) AIDS patients treated with the Company's
novel immunomodulator AVR118 showed improvement in appetite, weight gain or
stability, and enhanced quality of life in all the patients. None of the 15
patients reported any significant side effects from AVR118 (formerly known as
Product R) therapy. Cachexia is a state of body malnutrition and wasting with
loss of body fat and lean body weight.
The 15 patients who completed the trial included eight males, five on
highly active antiretroviral therapy (HAART), and seven females, five of whom
were receiving HAART. The primary indication of the trial is the treatment of
cachexia (body wasting). The patients are part of a Phase I/Phase II open-
label dose escalation clinical trial being conducted at The Kaplan Medical
Center in Rehovot, Israel.
"We have taken the unusual step of publicizing these preliminary results,
despite the small population of patients, because of the apparent strong
clinical results demonstrated, even in this short course treatment protocol,
by AVR118 in these very ill patients," said Eli Wilner, Chairman of the Board
of ADVR. "If the continuation of the study confirms these preliminary
findings, the value of AVR118 in treating body wasting in AIDS patients will
merit much broader scientific analysis in a large study of AIDS patients."
"These preliminary results are very encouraging because a positive
clinical effect was seen in virtually all patients following initiation of
treatment with AVR118, even at the lowest dosage," said James D'Olimpio, M.D.,
Director of the North Shore University Hospital's Supportive Oncology and
Palliative Care Service, and a member of ADVR's Scientific Advisory Board.
"The study design and quality of data is worthy of a presentation at an
appropriate international scientific meeting. I would encourage the
investigators to prepare an abstract once the statistical analysis of the data
set is completed so that these promising preliminary results can be shared
with the global scientific community." Dr. D'Olimpio has done extensive
research on cachexia, particularly in cancer patients.
When completed, the clinical trial will include a total of 30 patients,
with 10 each receiving AVR118 administered subcutaneously per day at the three
doses of 0.4 ml, 2 ml, and 4 ml. The trial protocol specifies a two-week
preliminary observation period followed by four weeks of AVR118 therapy and
four weeks of observation.
"The preliminary results demonstrate the potential utility of AVR118 in
this group of patients," said Richard A. Guarino, M.D., ADVR's clinical and
regulatory advisor.
"These preliminary results in cachectic AIDS patients are encouraging, and
I eagerly await possible confirmation of our preliminary results once all 30
patients have completed the trial," said Shalom Z. Hirschman, M.D., ADVR's
Chief Scientist. "These results garnered midway through the clinical trial
appear to validate our expectations of the clinical activity of the unique
immunomodulator AVR118."
ADVR's AVR118 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, AVR118 has been
termed a "switch-type" immunomodulator. AVR118 is in clinical trials in
Israel for the treatment of cachexia (body wasting) in patients with AIDS.
For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.com.
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. AVR118 (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 AVR118 or satisfy certain other conditions relating to
clinical trials including obtaining adequate insurance on terms acceptable to
the Company or that if completed, clinical trials performed outside the United
States will assist the Company in obtaining FDA or other regulatory approval.
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:
Eli Wilner
914-376-7383
SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
Company News On-Call:
http://www.prnewswire.com/comp/903002.html
CONTACT:
Eli Wilner, +1-914-376-7383, for Advanced
Viral Research Corp.
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