Here's the latest news folks - Jim
Thursday December 12 10:34 AM EDT
Paracelsian Announces Preliminary Results of Safety
Study Show AndroVir(TM) Well Tolerated with
Decreases in HIV Viral Load and Rapid Increases in
CD4 Positive Cells
ITHACA, N.Y., Dec. 12 /PRNewswire/ -- Paracelsian Inc today announced preliminary results of its initial human safety trial of AndroVir(TM) in HIV-positive subjects conducted by Bastyr University. Bastyr is a College of Natural Medicine (Naturopathy) located in Seattle, Washington,that studies natural products through the Bastyr University Integrated Care Clinic. AndroVir contains an extract of the herb Andrographis paniculata, an herb traditionally used in China and
India. The purpose of this trial was to study the safety and tolerability of AndroVir in humans infected with the HIV-1 virus and the safety objectives of the trial were achieved. Data obtained
on HIV indicators in participants through nine weeks also suggests that AndroVir has positive activity in humans infected with the HIV-1 virus. Subjects were not on any anti-viral therapy for
the duration of the trial.
The nine-week phase 1 clinical trial of AndroVir was conducted in sixteen HIV-1 positive individuals that received a 5 mg/kg dose three times per day for the first three weeks, followed by a 10 mg/kg dose three times per day for the second three weeks. Elevations or viral load in two subjects at the end of the first three weeks (5 mg) caused the protocol to be amended from a proposed increased dose of 20 mg three times per day to a withdrawal or washout period for the
final three week period. The elevations turned out to be transient and at six weeks (10 mg) the viral load of these subjects decreased to the range of the other individuals. A very slight increase
in two liver enzymes, AST and ALT was observed in two subjects, which may indicate lower tolerance for the herb in some individuals. Thirteen of the initial sixteen subjects completed the
study. Of the three participants that withdrew, two experienced a bitter taste and the third displayed severe allergic hypersensitivity.
Oral administration of AndroVir for six weeks was otherwise well-tolerated and produced a median decrease in HIV-1 viral load of 38 percent as well as a median increase in CD4 cell
counts of 31 percent. One subject experienced an 83 percent decrease in HIV-1 viral load and another exhibited a 90 percent increase in CD4 cells in six weeks. In addition, there was a mean
rise of 14 percent in serum cholesterol observed as well as an increase in complete white blood cell counts. During the AndroVir withdrawal period, all these beneficial trends were reversed and
approached pre-study values in all but one subject. "Overall, participants in the study were excited about the results and a majority of them wanted to continue after the completion of the
trial," noted Dr. Sheryl Miller, Principal Investigator for the study.
Dr. John G. Babish, Vice President and Chief Science Officer, had the following comment: "These results highlight AndroVir's potential. The design of this trial was to introduce increasingly
larger amounts of AndroVir in relatively short periods of time. The effect on HIV-1 viral load and CD4 cells demonstrated in this clinical study indicates that AndroVir supports normal immune function. We now have useful data concerning dose ranges that will help with our product development strategy. Our plans from this point are to optimize dose regimens and characterize the longer term benefits of AndroVir by conducting further studies over longer periods of time.
Given the dose ranges we are considering, we expect the product cost will be less than $1,000 per year."
Paracelsian is a biotechnology company engaged in the discovery of useful products front herbal sources. Its discoveries are accomplished by applying the Company's proprietary screening technology, based in signal transduction, to its library of extracts used in Traditional Chinese Medicine.
This press release contains certain statements of forward-looking nature that involve risk and uncertainty. Management wishes to caution the reader that these forward-looking statements are only predictions; actual events or results may differ materially as a result of risks facing the Company. Such risks include, but are not limited to, the timing and results of future clinical studiesand marketing strategies as well as the Risk Factors listed in Paracelsian, Inc.'s Annual Report for the year ended September 30, 1995. SOURCE Paracelsian, Inc. |
