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Boehringer Ingelheim Announces 24-Week Interim Results from Tipranavir RESIST-1 Phase 3 Study

Washington, November 1 (ots/PRNewswire)

New data from a pivotal
Phase 3 study (RESIST-1) demonstrate that a statistically significant
greater percentage of HIV-positive patients taking a tipranavir-based
regimen achieved a treatment response versus those taking a regimen
containing one of several marketed protease inhibitors (PIs).
Treatment response in this study of treatment-experienced patients
was defined as a 1 log(10) or greater decrease in viral load from
baseline. Tipranavir is an investigational non-peptidic protease
inhibitor that requires boosting with low-dose ritonavir. These data
were presented at the 44th Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC).
RESIST-1 was conducted in 620 patients in the United States,
Canada, and Australia. A related study, RESIST-2, enrolled 863
patients in Europe and Latin America. The interim analyses of
RESIST-1 and RESIST-2 formed the foundation of the New Drug
Application (NDA), which was submitted to the U.S. Food and Drug
Administration (FDA) for marketing approval of tipranavir on October
22, 2004.
In the RESIST-1 study (1182.12), treatment response, defined as a
1 log10 or greater decrease in viral load from baseline, was achieved
by 41.5% of patients who received tipranavir/r, versus 22.3% of
patients in the comparator protease inhibitor boosted with low-dose
ritonavir (CPI/r) arm (p<0.0001). Moreover, a greater proportion of
patients receiving tipranavir therapy achieved a viral load below the
level of quantification than those who were treated with a CPI/r.
At 24 weeks, 34.7% of participants in the tipranavir/r group and
16.5% of participants in the CPI/r group achieved viral loads of less
than 400 copies/mL, and 25.1% vs. 10% achieved less than 50 copies/mL
(p<0.001). Patients who received enfuvirtide as part of their
treatment were generally more immuno-compromised. For these patients,
their response rates improved to 47.1% vs. 21.9% (<400 copies/mL) and
32.8% vs. 14.3% (<50 copies/mL). These differences remain
statistically significant.
Patients taking tipranavir/r also experienced greater increases in
their CD4+ cell count than those taking a CPI/r, with CD4+ increases
of 36 cells/mm3 and 6 cells/mm3, respectively (p<0.001).
"RESIST-1 examined patients with advanced HIV disease who, on
average, previously received 12 antiretroviral drugs, were
experiencing virologic failure, and had documented PI resistance,"
said Charles Hicks, M.D., Associate Professor of Medicine in the
Division of Infectious Diseases at Duke University Medical Center.
"These data suggest that tipranavir could have the potential to
advance the care of treatment-experienced patients."
The tipranavir/r adverse event profile was similar to events
observed in the CPI/r group through 24 weeks. The participants in the
tipranavir/r group experienced a higher rate of liver enzyme and
lipid elevations; however, most laboratory abnormalities were
asymptomatic and most patients were successfully treated without
treatment discontinuation.
"Boehringer Ingelheim is pleased about the encouraging preliminary
results from RESIST-1," 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.
"This important milestone brings us one step closer to providing
tipranavir to patients in need of new HIV treatment options."
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-1 is a randomized, controlled, open-label Phase 3 trial
designed to study the safety and efficacy of tipranavir, boosted with
low-dose ritonavir, versus a low-dose ritonavir-boosted CPI in
treatment-experienced patients with documented PI resistance. All
patients had baseline genotypic resistance testing prior to
randomization to aid investigators in the selection of the CPI/r.
Patients enrolled in RESIST-1 were randomized to receive a
500mg/200mg twice-daily dose of tipranavir combined with ritonavir or
a CPI combined with ritonavir at its standard boosting dose. CPIs
included lopinavir, saquinavir, amprenavir or indinavir. All patients
combined their PI with an optimized background regimen (OBR) of
anti-HIV medications. The OBR was selected on the basis of treatment
history and baseline genotypic resistance testing. The use of
enfuvirtide was allowed, but had to be selected by investigators
prior to randomization.
Tipranavir
Tipranavir is a non-peptidic protease inhibitor currently in late
Phase 3 clinical development - the final stage of clinical testing
prior to FDA review. Tipranavir is also being evaluated for use in
pediatric and treatment-naïve patient populations in Phase 2 studies
that are currently underway.
Based on available clinical and in vitro data, tipranavir appears
to remain active against strains of HIV-1 that are resistant to
commercially available protease inhibitors. Ongoing clinical studies
are designed to confirm these data.
In studies to date, the most commonly reported adverse events are
gastrointestinal-related and include diarrhea, nausea, fatigue,
headache and vomiting. The most common laboratory abnormalities are
elevated liver enzymes (AST/ALT) and triglycerides.
Tipranavir does not cure HIV infection/AIDS or prevent the
transmission of HIV to others.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. VIRAMUNE(R) (nevirapine), a product
of original research done at Boehringer Ingelheim, was the first
member of the non-nucleoside reverse transcriptase inhibitor (NNRTI)
class of anti-HIV drugs. Boehringer Ingelheim is involved in basic
research and is committed to the development of tipranavir and
improving HIV therapy by providing physicians and patients with
innovative antiretrovirals.
For more information on Boehringer Ingelheim Pharmaceuticals,
Inc., please visit http://us.boehringer-ingelheim.com.
Reference:
Hicks et al. RESIST-1: A Phase 3 Randomized, Controlled,
Open-Label Multicenter Trial Comparing Tipranavir/Ritonavir (TPV/r)
to an Optimized Comparator Protease Inhibitor/r (CPI/r) Regimen in
Antiretroviral (ARV) Experienced Patients: 24-Week Data, 44th
Interscience Conference on Antimicrobial Agents and Chemotherapy;
October 31 - November 2, 2004, Washington, D.C. Abstract #3726
Contact:
    Ann Davin
    Public Relations Manager
    Boehringer Inngelheim Pharmaceuticals, Inc
    900 Ridgebury Road
    Ridgefield, CT 06877
    Phone: +1 (203) 791-6318
    Fax: +1 (203) 791-6442
    E-mail:  adavin@rdg.boehringer-ingelheim.com
    Kristin Osborn
    GCI Healthcare
    825 Third Avenue
    New York, NY 10022
    On-site at ICAAC: +1 (646) 319-9681
    Phone: +1 (212) 537-8022
    Fax: +1 (212) 537-8250
    E-mail:  kosborn@gcigroup.com
Web site: http://us.boehringer-ingelheim.com

Contact:

Ann Davin, Public Relations Manager of Boehringer Ingelheim
Pharmaceuticals, Inc., +1-203-791-6318, or Fax, +1-203-791-6442, or
adavin@rdg.boehringer-ingelheim.com; or Kristin Osborn of GCI
Healthcare,
On-site at ICAAC: +1-646-319-9681, +1-212-537-8022, or Fax,
+1-212-537-8250,
or kosborn@gcigroup.com, for Boehringer Ingelheim

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