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Boehringer Ingelheim

Boehringer Ingelheim Announces 24-Week Results From Second Phase III Pivotal Study of Tipranavir

Glasgow, Scotland, November 18 (ots/PRNewswire)

- RESIST-2 Data Demonstrate Efficacy in Treatment-Experienced
Patient Population
New tipranavir pivotal Phase III data show that a statistically
significant higher percentage of treatment-experienced HIV-positive
patients taking tipranavir therapy achieved treatment response versus
those taking other currently available protease inhibitors.
Tipranavir is an investigational non-peptidic protease inhibitor in
development by Boehringer Ingelheim. These data from the RESIST-2
study were presented at the 7th International Congress on Drug
Therapy in HIV Infection in Glasgow.
In RESIST-2 (1182.48), treatment response was achieved by 41.0% of
patients who received tipranavir boosted with low-dose ritonavir
(tipranavir/r) compared to 14.9% of patients treated with a
comparator protease inhibitor boosted with low-dose ritonavir (CPI/r)
(p<0.001). Treatment response was defined as a 1 log(10) or greater
decrease in viral load from baseline over 24 weeks.
Moreover, a greater proportion of patients receiving tipranavir/r
achieved a viral load below the level of quantification than those
who were treated with a CPI/r. At 24 weeks, 33.6% of participants in
the tipranavir/r group and 13.1% of participants in the CPI/r group
achieved viral loads of less than 400 copies/mL, and 22.5% vs. 8.6%
achieved less than 50 copies/mL (p<0.0001). Patients taking
tipranavir/r also experienced greater increases in their CD4+ cell
count than those taking a CPI/r, with CD4+ increases of 31
cells/mm(3) and 1 cell/mm(3), respectively (p=0.02).
A subset of the study population received enfuvirtide as part of
their treatment regimen. Of these patients, who generally had more
impaired immune systems, 38.5% in the tipranavir/r arm vs. 13.0% in
the CPI/r arm achieved a viral load of less than 400 copies/mL, and
23.1% vs. 4.3% achieved less than 50 copies/mL. These differences are
statistically significant.
The RESIST-2 study was conducted in 863 patients in Europe and
Latin America. Baseline characteristics, including median viral load
and CD4+ cell count, were similar for patients in the tipranavir/r
and the CPI/r groups. Patients in the study had received, on average,
11 previous antiretroviral drugs, were experiencing virologic
failure, and had documented PI resistance.
The adverse event profile of the tipranavir/r group was similar to
the CPI/r group through 24 weeks. The tipranavir/r group experienced
a higher rate of liver enzyme and lipid elevations; however, most
laboratory abnormalities were asymptomatic and most patients remained
on treatment without permanent discontinuation.
"There is an increasing need for treatments that are effective in
combating drug resistant virus," said Dr. Pedro Cahn of the Fundacion
Huesped, Buenos Aires, Argentina. "The RESIST-2 data suggest that
tipranavir may have the potential to improve the care of
treatment-experienced patients."
A related Phase III pivotal study, RESIST-1, was conducted in 620
patients in the United States, Canada and Australia. RESIST-1 study
results were presented last month at the Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. Data
from RESIST-1 and RESIST-2 formed the foundation of the submission
packages to international regulatory authorities for marketing
approval of tipranavir.
"Boehringer Ingelheim is pleased by the interim results from the
RESIST-2 pivotal study," said Dr. Andreas Barner, Vice-Chairman of
the Board of Managing Directors and Head of Corporate Board Division
Pharma Research, Development and Medicine at Boehringer Ingelheim.
"These results, combined with those from RESIST-1, suggest that
tipranavir may offer the international HIV community a much needed
treatment option for patients whose virus is resistant to available
protease inhibitors."
Study Design
The RESIST (Randomized Evaluation of Strategic Intervention in
Multi-Drug ReSistant Patients with Tipranavir) clinical trial program
is one of the largest study programs undertaken with an
investigational antiretroviral agent in patients previously treated
with multiple combinations of antiretroviral drug regimens.
RESIST-2 is a randomized, controlled, open-label Phase III trial
designed to study the efficacy and safety of tipranavir, boosted with
low-dose ritonavir, versus a low-dose ritonavir-boosted comparator PI
in treatment-experienced patients with documented PI resistance. All
patients received baseline genotype testing prior to randomization to
aid investigators in the selection of the comparator PI.
Patients enrolled in RESIST-2 were randomized to receive an
optimized standard of care regimen containing tipranavir/r
500mg/200mg twice daily or a CPI/r at its standard dose. CPIs
included lopinavir, saquinavir, amprenavir and indinavir. Optimized
background regimens were chosen by patients' physicians on the basis
of treatment history and baseline genotypic resistance testing. The
use of enfuvirtide was allowed, but had to be pre-selected by
investigators prior to randomization.
Tipranavir
Tipranavir is a non-peptidic protease inhibitor currently in Phase
III of clinical development. In June 2004, Boehringer Ingelheim
announced the enrollment of the first patient in a broad-scale global
tipranavir Compassionate Use Program, which provides access to
HIV-positive patients in clinical need of new treatment options.
Tipranavir is also being evaluated for use in pediatric and
treatment-naive patient populations. Phase II studies are currently
underway.
Based on available clinical and in vitro data, tipranavir is
active against most strains of HIV-1 that are resistant to
commercially available protease inhibitors. Ongoing studies are
designed to confirm these data.
In studies to date, tipranavir has been well tolerated by most
patients and has a safety profile similar to other PIs. The most
commonly reported adverse events across all clinical trials were
gastrointestinal-related and included diarrhea, nausea, fatigue,
headache and vomiting. Consistent with other PIs, the most common
laboratory abnormalities were elevated liver enzymes and
triglycerides.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. VIRAMUNE(R) (nevirapine) is a product
of original research done at Boehringer Ingelheim. VIRAMUNE was the
first member of the non-nucleoside reverse transcriptase inhibitor
(NNRTI) class of anti-HIV drugs. Boehringer Ingelheim is committed to
the rapid development of the investigational non-peptidic protease
inhibitor (NPPI) tipranavir in Phase III development and the
nucleoside analogue (NRTI) alovudine in Phase II development. The
company is involved in basic research and is committed to improving
HIV therapy by providing physicians and patients with innovative
antiretrovirals.
For more information on Boehringer Ingelheim, please see
http://www.boehringer-ingelheim.com/hiv .
Reference:
Cahn et al. 24-week data from RESIST 2: Phase 3 study of the
efficacy and safety of either tipranavir/ritonavir (TPV/r) or an
optimized ritonavir (RTV)-boosted standard-of-care (SOC) comparator
PI (CPI) in a large randomized multicenter trial in
treatment-experienced HIV+ patients. 7th International Congress on
Drug Therapy in HIV Infection, Glasgow, UK, November 18, 2004.
Abstract #: PL 14.3
Web site: http://www.boehringer-ingelheim.com
              http://www.boehringer-ingelheim.com/hiv

Contact:

Julia Meyer-Kleinmann, CD Communications, Boehringer Ingelheim GmbH,
+49-61-32-77-8271, or fax +49-61-32-77-6601, or
M-Kleinmann@ing.boehringer-ingelheim.com

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