All Patients with Anorexia at Entry Regained Appetite
YONKERS, N.Y., June 6 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) announced today that the company presented
interim results of its Phase 1/2 clinical program with its flagship product,
AVR118, at The American Society of Clinical Oncology's (ASCO) 40th Annual
Meeting in New Orleans, LA.
The presentation "Anti-Cachectic Effects of a Novel Peptide Nucleic Acid
Complex: Preliminary Results of a Phase1/2 Clinical Trial," given by James T.
D'Olimpio M.D, showed the results of Phase 1/2 clinical trials conducted in
Israel. A total of 25 cachectic patients (patients with cancer cachexia or
AIDS wasting) were enrolled in the trials. Ten patients with advanced AIDS
and two patients with advanced pancreatic cancer received AVR118
subcutaneously at a dose of 0.4 ml/day for 28 days (6 days/week). Eight AIDS
patients received a dose of 2.0 ml/day and five patients received 4.0 ml/day
at the same schedule.
All patients were followed for 28 days after treatment was completed.
Total weight, body mass index (BMI), fat percentage, strength, calf and arm
circumference, and skin fold were measured for all AIDS patients. Spontaneous
patient comments regarding quality of life (QOL) parameters, including
improvement in mood, appetite, alertness, activities of daily living (ADLs),
malaise, myalgia and power/energy were recorded. Adverse events were
monitored.
All dose groups showed an increase in weight, strength and fat percentage,
with more significant improvements in the two higher dose levels. All patients
with anorexia at entry became anorexia-free after three weeks of therapy.
Spontaneous patient comments reflect widespread, dose-related improvements in
Quality of Life (QOL). AVR118 continues to show a favorable safety profile.
"This trial was designed as a dose-escalation study and we are pleasantly
surprised to see such strong data given the relatively short treatment
period," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research
Corp. "We are very encouraged by the results, most importantly with the
resolution of anorexia in all study participants."
Results Reported - AIDS:
0.4 ml dose
* All patients were anorexia-free after three weeks of treatment. (One
patient did not have anorexia at baseline).
* Half of the patients reported increased daily activity.
2 ml dose
* All patients were anorexia-free after three weeks of treatment.
* At the end of four weeks of treatment the average weight of patients
increased by over a pound.
* All patients had an increase of fat percentage after treatment and this
was sustained in the majority of patients.
* Approximately half of the patients reported an improvement in their
mood and increased daily activities.
4 ml dose
* All patients were anorexia free after three weeks of treatment. It is
important to note that 50 percent of patients had Grade Two anorexia at
baseline.
* Patients in this cohort increased their average weight by 2.2 pounds
over four weeks of treatment. This effect continued through the
following four weeks at which point the average weight had increased by
2.6 pounds over baseline.
* All patients showed an increase in fat percentage which was sustained
after treatment discontinuation in all patients.
* 100 percent of patients reported an increase in daily activity.
* 80 percent of patients reported decreased fatigue.
Results Reported - Pancreatic Cancer:
* Both patients had improved weight (4% increase)
* Improved fat percentage (20% increase)
* Improved strength (5 % increase)
ADVR's AVR118 represents a biopolymer that possesses novel immunomodulator
activity. This peptide-nucleic acid complex, which to date has demonstrated a
very favorable safety profile, appears to stimulate the proinflammatory
responses required to combat viral infections such as AIDS and human
papillomavirus and to dampen aberrant autoimmune-type inflammatory responses,
such as occur in patients with rheumatoid arthritis. 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: Ronnie Welch or
Kelly Cinelli
CWR & Partners
508/222-4802
SOURCE Advanced Viral Research Corp.
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http://www.adviral.com
Company News On-Call:
http://www.prnewswire.com/comp/903002.html
CONTACT:
Ronnie Welch or Kelly Cinelli, both of CWR &
Partners, +1-508-222-4802
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