YONKERS, N.Y., March 11 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced that it has submitted the
results of a Phase 1 study for the topical use of Product R in the treatment
of genital warts caused by infection with the human papilloma virus (HPV) to
the U.S. Food and Drug Administration (FDA). Overall results of the Phase 1
clinical trial indicate that Product R was safe and well tolerated
dermatologically in all the doses applied in the study.
According to data from the Centers for Disease Control and Prevention
(CDC), at any one time an estimated 20 million people in the United States
have genital HPV infection that can be transmitted. CDC considers genital
infection with HPV to be an increasing public health problem, particularly
among young sexually active persons. Advanced Viral Research Corp. believes
there is a need for more effective and better-tolerated therapeutic options.
"We are extremely pleased with the safety results of Product R," stated
Shalom Z. Hirschman, M.D., President and CEO of Advanced Viral Research Corp.
"The submission of these results to the FDA marks the completion of Phase 1 of
the IND application for the topical therapy of genital warts with Product R.
The data accrued in this Phase 1 study form the basis for the Phase 2 protocol
to be submitted to the FDA. We look forward to progressing with this IND
application as quickly as possible following submission and review by the FDA
of our Phase 2 protocol."
Study Design
The Phase 1 trial was a placebo-controlled, open-label, single-center dose
escalation study in 30 healthy volunteers. It was designed to assess the
safety and tolerability of Product R applied topically to the forearm. The
study subjects were admitted to the clinical study unit for 14 days. Six
escalating doses were evaluated with each cohort comprising five subjects.
The cohorts were enrolled sequentially, commencing when subjects from the
previous cohort completed the third day of evaluation.
Beginning on the first day, Product R was applied topically to the forearm
of treated subjects twice a day for 14 days. The study subjects were
randomized so that each subject received Product R to one forearm, either
right or left, and saline control to the other. Product R was applied to the
same area of the skin with each sequential dose. The study subjects were
discharged from the trial unit twelve hours after the last application on the
14th day and were requested to return for a follow up evaluation seven days
after discharge.
Tolerability was evaluated by scoring the application site for erythema
(redness), edema (swelling), and other signs of irritation as well as any
discomfort experienced by the study subjects. Safety was assessed by
documentation of vital signs, including blood pressure, pulse, and respiratory
rate, laboratory tests, and examinations for adverse events. The results of
the study were analyzed by statistical methods and summarized in tables.
U.S. Phase 1 Study Results
There were no serious dermatologic adverse events observed in this Phase 1
study. Most of the 43 dermatologic treatment-emergent adverse events (AE)
that were observed consisted of erythema or other local skin reactions and
occurred in both the Product R and placebo treated subjects. All of the
adverse events observed during this Phase 1 clinical trial were considered to
be mild. The most frequent finding on physical examination in all subjects
was slight erythema in the area of the tape on the forearms of the subjects.
There was no dose response relationship in any of the findings. Furthermore,
there were no dose-limiting toxicities causing a discontinuation of the trial
in any subject.
The study was conducted at Novum Pharmaceutical Research Services in
Pittsburgh, Pennsylvania under the supervision of Globomax, LLC.
Product R Israeli Studies
"We continue to make progress with the clinical development of Product R,"
Dr. Hirschman continued. "We recently met with clinical investigators at the
Selikoff Center and participating medical centers in Israel and we are
awaiting necessary regulatory approvals for a new and expanded program of
clinical trials so that we can initiate Phase 1 clinical trials for systemic
uses of Product R."
The Israeli clinical trials address systemic uses of Product R in
potentially large therapeutic categories, including: treating cachexia (body
wasting) in patients with neoplasias of lymphocytic cells, i.e., acute
lymphocytic leukemia, Hodgkins lymphoma and non-Hodgkins lymphoma; treating
cachexia in patients with solid tumors such as cancers of the colon, kidney,
lung and breast; and as salvage therapy in patients with AIDS who have failed
highly active anti-retroviral therapy (HAART).
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 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 complete the clinical trials of Product
R. 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.
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Related links:
http://www.adviral.com
CONTACT:
Mayr Communications, Inc., +1-877-777-6010,
mayrcomm@att.net, for Advanced Viral Research Corp.
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