Tuesday December 10 9:01 AM EDT
Advanced Viral Research Reports on Clinical Results of
RETICULOSE in Patients With AIDS
NEW YORK, Dec. 10 /PRNewswire/ -- Advanced Viral Research Corp today announced preliminary results of a
clinical trial of its peptide nucleic acid drug RETICULOSE in patients with AIDS. The double-blind, randomized,
placebo-controlled clinical trial is being conducted at The Queen Elizabeth Hospital, University of the West Indies
School of Medicine, Barbados, by Henry Fraser, M.D., Timothy Roach, M.D., and Paul Levett, Ph.D.
According to a written summary of the trial by Dr. Levett, forty-three patients never previously treated with HIV
anti-retroviral therapy, were enrolled in the study. Twenty-one patients received RETICULOSE and twenty-two
patients received placebo, administered daily, every other week, for a sixty- day period. Patients were observed for
another sixty days following the conclusion of treatment.
The polymerase chain reaction (PCR) assays for viral load were performed by LabCorp (Roche), and the CD4
counts were performed by SmithKline Beecham Clinical Laboratories.
At the end of the sixty-day treatment period, the key results of this preliminary report were:
-- A 37 percent increase in the mean CD4 positive T-cell lymphocytes counts in patients receiving RETICULOSE as
compared with a 7 percent decrease in the control group that received placebo, and
-- A 21 percent average decrease in HIV viral load, as measured by quantitative RNA PCR, in the
RETICULOSE-treated patients, in contrast to a 33 percent increase in HIV viral load in the control group.
At the end of the sixty-day observation period the mean HIV viral load of the treated group was less than half (42
percent) of the control group.
Eighty-three percent of the patients who received RETICULOSE had a rise in blood hemoglobin and 61 percent had
a rise in hemoglobin equal to or greater than one gram per deciliter (gm/dl). In contrast, 44 percent of patients who
received placebo had a rise in blood hemoglobin during the study period, and in only 25 percent was the increase
equal to or greater than 1 gm/dl.
Clinically, 72 percent of patients who were given RETICULOSE maintained or increased their body weight. This
occurred in only 30 percent of the placebo- treated patients.
There was zero toxicity and no side effects were observed by physicians or reported by patients as a result of
RETICULOSE therapy.
"In view of the encouraging preliminary results of this clinical study in AIDS patients and the absence of any toxic side
effects, we are eager to move forward to the next stage of this clinical trial with RETICULOSE," said Shalom Z.
Hirschman, M.D., President and Chief Executive Officer of Advanced Viral Research Corp. "Drs. Fraser, Roach and
Levett plan to submit the results for publication upon completion of the trial."
The study is being supported by Advanced Viral Research Corp. ADVR is developing RETICULOSE, a non-toxic
peptide nucleic acid preparation, that in the past was used to treat a number of viral infections. The company has
neither monitored nor observed this clinical trial.
NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including 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 ADVR. RETICULOSE is
not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries.
SOURCE Advanced Viral Research Corp |
