Positive Results From 1996 ALLERVAX RAGWEED Product Trial
PR Newswire, Monday, January 27, 1997 at 16:39
WALTHAM, Mass., Jan. 27 /PRNewswire/ -- ImmuLogic Pharmaceutical
Corporation (Nasdaq: IMUL) today announced that preliminary analyses of the
1996 double-blind, placebo-controlled ragweed season trial show that the
eight-dose 250 microgram group of ALLERVAX(R) RAGWEED product significantly
improved patients' ragweed allergies and significantly reduced medication use
across the ragweed allergy season. A primary efficacy objective of this
study, the rhinoconjunctival symptom-medication index comparison of the eight-
dose 250 microgram group to the eight-dose placebo group, was statistically
significant with an improvement of 17% (p<0.04) across the season. In
addition, the 250 microgram dose group demonstrated an important objective
secondary measurement of efficacy, a reduction in decongestant and
antihistamine medication use across the season of 39% (p=0.03).
Additional secondary endpoint measurements include comparisons between the
ALLERVAX RAGWEED treated groups and an observational group. The observational
group did not receive any treatment (drug or placebo) and was added to the
study to confirm and quantitate the placebo effect typically seen in allergy
trials. The company believes this comparison provides a better understanding
of the real clinical benefit derived from use of the ALLERVAX RAGWEED product.
A 31% (P<0.001) improvement was seen in the rhinoconjunctival symptom-
medication index for the eight-dose 250 microgram group compared to the
observation group. Medication use was 54% (p=0.001) lower in the eight-dose
250 microgram group compared to the observation group. An analysis of the IgE
antibody responses across the season, another secondary endpoint, did not show
significant differences among groups.
"This trial, the first to evaluate the eight-dose 250 microgram regimen,
produced very positive results," said Dr. Joseph Marr, acting President and
Chief Executive Officer of ImmuLogic Pharmaceutical Corporation. "It
successfully demonstrated efficacy, quantitated the clinical benefit through
comparison of the treated group to the observation group, and showed that the
ALLERVAX RAGWEED product had a significant impact on reducing medication use.
We believe these data document a significant treatment benefit and that the
product is efficacious. We anticipate that completion of the clinical
development program for this product will require similar results from a 1997
ragweed seasonal trial."
The ALLERVAX RAGWEED product was very well tolerated in this study. The
adverse events in the placebo and treated groups were virtually identical.
There was only a 4% increase in the latter group. No drug-related serious
adverse events occurred and the adverse events, predominantly categorized as
mild, were comparable across all treatment and placebo groups.
Another objective of this study was to evaluate the efficacy of the
ALLERVAX RAGWEED product four-dose 750 microgram group compared to the four-
dose placebo group in reducing the rhinoconjunctival symptom-medication index
across the season. The improvement seen in this trial was consistent with the
improvement seen in the 1995 ragweed trial; however, this improvement was not
statistically significant. Dr. Marr continued, "With the results obtained
from the eight-dose 250 microgram group, we have clearly identified a
substantially better treatment regimen and have validated the technology
platform supporting both our allergy and autoimmune programs. We believe it
is clear from these data that the eight-dose 25O microgram treatment regimen
decreases the symptoms of ragweed allergies in a clinically meaningful way,
with no significant risk from therapy."
Results of this trial will be discussed by clinical investigators as part
of several presentations at the upcoming American Academy of Allergy, Asthma
and Immunology meeting (AAAAI) in San Francisco February 21-26, 1997. The
company will be presenting preliminary analyses of data from this trial in a
conference call for investors at 8:30 AM EST on January 28, 1997. To
participate, please dial 1-800-309-3487 and ask for the ImmuLogic call led by
Susan Primrose.
ImmuLogic Pharmaceutical Corporation is a biopharmaceutical company,
located in Waltham, Massachusetts, with the primary goal of developing peptide
therapeutics to treat allergies, including cat and ragweed allergies, and
autoimmune diseases such as multiple sclerosis. The Company also is
developing a vaccine to treat cocaine abuse. The company's press releases are
available through Company News on Call by fax at 800-758-5804 ext. 114501, and
on the Internet at www.prnewswire.com.
This press release contains certain forward-looking statements concerning
the clinical development timeframes for the ALLERVAX RAGWEED product. These
statements are based on current expectations which involve risks and
uncertainties. Actual results may differ significantly. Factors that might
cause such differences include the interpretation of results by the FDA and
the timely initiation of future clinical trials as well as other factors
identified in the "risk factors" sections of the ImmuLogic Pharmaceutical
Corporation SEC filings such as the 10K for the year ended 1995.
SOURCE ImmuLogic Pharmaceutical Corporation
-0- 1/27/97
/CONTACT: Susan Primrose, Director of Investor Relations of ImmuLogic
Pharmaceutical Corp., 617-466-6000/
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