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ROCHE AND TRIMERIS ANNOUNCE 24-WEEK RESULTS
FROM SECOND PIVOTAL STUDY OF HIV FUSION INHIBITOR T-20
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-- Second of two Phase III studies meets primary endpoint;
companies will proceed with filing US and EU registration packages
in the second half of 2002 --
(editorial note: the results from these studies show T20 giving a significant
benefit for patients with limited treatment options due to resistance to HIV
drugs, and who had advanced HIV. T20 appears to represent an important new
treatment for patients with resistance to current drugs and advanced HIV. The
FDA should be reviewing the drug for approval and I think approval is
expected by the end of first quarter 2003. As mentioned below, in the Fall
2002 an access program for T-20 to patients with immediate need is expected
to open when increased drug supply is expected to be available).
NUTLEY, NJ and DURHAM, NC (May 16, 2002) - Roche and Trimeris, Inc. today
announced positive 24-week results from the second pivotal Phase III study of
T-20 (TORO 2), just four weeks after reporting similarly positive 24-week
results from the first Phase III study of T-20. Together, the results from
TORO 2, as well as the results from the first study, TORO 1, will form the
basis of the submission to regulatory authorities.
T-20 is the furthest in clinical development in an investigational class of
antiretrovirals called fusion inhibitors. Unlike currently approved classes
of antiretrovirals that work inside the cell and target viral enzymes
involved in the replication of the virus, clinical trials have shown that
T-20 inhibits fusion of HIV with host cells before the virus enters the cell
and begins its replication process.
The results from the TORO 2 study show that T-20 administered in combination
with an optimized antiretroviral treatment regimen provides a significant
additional decrease in the amount of virus in the blood as compared to an
optimized antiretroviral treatment regimen alone. TORO 2 was conducted in
504 HIV infected patients in Europe and Australia who were
treatment-experienced and/or had documented resistance to each of the three
classes of currently available anti-HIV drugs.
At baseline, patients had a median HIV RNA level of over 5 log copies/mL
(100,000 copies/ml HIV viral load) and extensive prior exposure to multiple
anti-HIV drugs. At 24 weeks, patients who received T-20 as part of their
combination regimen achieved a mean reduction in HIV levels of 1.43 log
copies/mL compared to a mean of 0.65 log copies/mL for those who were
randomized to the control arm, calculated in accordance with the study
protocol. The primary efficacy endpoint for the study, the difference in the
magnitude of decrease in HIV between the two arms at 24 weeks, was 0.78 log
copies/mL and was statistically significant (p<0.0001). Roche and Trimeris
expect to present these data in detail at scientific conferences in the next
several months.
"This is the second large pivotal study to demonstrate that T-20
significantly enhances the activity of combination therapy in
treatment-experienced HIV patients over 24 weeks. The excellent results from
TORO 2 confirm and build upon those from TORO 1, the first pivotal study,"
said Georges Gemayel, Vice President, Specialty Care, Roche. "Taken
together, these data represent a significant milestone in our commitment to
deliver new options for people living with HIV."
"The positive results from TORO 2 are both clinically and statistically
significant. It is remarkable that both TORO studies consistently
demonstrate the substantial treatment effect of T-20 across a diverse,
treatment-experienced patient population from a number of countries. The
Roche and Trimeris collaboration plan to proceed with filing registration
packages for T-20 in the US and EU early in the second half of the year,"
said Dani Bolognesi, Chief Executive Officer, Trimeris.
"This important milestone brings T-20, the first member of a new class of
antiretrovirals, yet another step closer to patients in need."
Safety Results
Through 24 weeks, as in TORO 1, overall clinical adverse events aside from
injection site reactions were similar between T-20 and control groups. Other
adverse events (>10%) occurring more frequently in the T-20 group were
headache, fever, and asthenia. It was not possible to establish a causal
relationship between these other adverse events and T-20. Grade 3 laboratory
abnormalities were more frequent in the T-20 group, and Grade 4 laboratory
abnormalities were more frequent in the control group. In TORO 2,
discontinuation at 24 weeks was 17 percent in the T-20 group and 5 percent in
the control group. Patients experiencing virologic failure in the control
group could switch to a T-20 regimen and not discontinue the study. While
most patients on the T-20 arm experienced injection site reactions, only 3
percent of patients discontinued the study as a consequence.
Early Access to T-20
In November 2001, Roche and Trimeris announced the initiation of the T-20
open-label safety study (T20-305) to provide T-20 to 450 patients around the
world. The study is ongoing and is being conducted in Australia, Brazil,
Europe and North America. Roche and Trimeris are committed to starting early
access programs in the second half of this year when increased drug supply is
expected to be available.
Study Design
TORO 2 (T-20 vs. Optimized Regimen Only), previously known as T20-302, and
TORO 1 (previously known as T20-301) are randomized, open-label trials that
enrolled approximately 1,000 patients at 112 centers worldwide. TORO 2 is
being conducted in Australia, Belgium, France, Germany, Italy, The
Netherlands, Spain, Sweden, Switzerland and the United Kingdom, TORO 1 is
being conducted in North America and Brazil. Patients in the trials were
treatment-experienced and/or had documented resistance to each of the three
classes of currently-available antiretrovirals. In addition, each patient
was required to have a plasma HIV-RNA level of greater than 5,000 copies/mL.
Patients are expected to undergo treatment for 48 weeks, with an optional
48-week treatment extension. At entry, genotypic and phenotypic resistance
testing was used to aid in the selection of an antiretroviral regimen,
consisting of three to five drugs, including if appropriate, up to two newly
approved or investigational drugs. After selection of the regimen, patients
were randomized 2:1 to receive either the regimen in combination with T-20 or
the regimen alone. Patients randomized to T-20 receive T-20 administered as
one 90 mg subcutaneous self-injection twice-daily.
Meeting the Growing Need For a New Class of HIV Drugs
One of the biggest challenges facing people living with HIV is resistance to
currently available therapies. Thirty to fifty percent of patients are
infected with a strain of the virus that has developed resistance to one or
more antiretrovirals, thereby reducing the treatment options available to
them. Roche and Trimeris are committed to discovering and developing
treatments for patients in need of new options and expect to invest
approximately half a billion U.S. dollars to bring fusion inhibitors to
people living with HIV/AIDS.
Long-Term Commitment to HIV Research and Development
Roche and Trimeris are working together to mobilize the considerable
resources required to support the rapid development of T-20, the first member
of a new class of investigational anti-HIV drugs known as fusion inhibitors.
T-20, currently in Phase III clinical trials, is the furthest along in
clinical development in the entry inhibitor class. T-1249, a second
generation fusion inhibitor being developed by Roche and Trimeris, is in
Phase I/II clinical trials. Unlike existing AIDS drugs that work inside the
cell and target viral enzymes involved in the replication of the virus,
clinical trials have shown that T-20 inhibits fusion of HIV with host cells
before the virus enters the cell and begins its replication process. In June
2001, Roche and Trimeris announced a joint research agreement to identify and
develop additional HIV fusion inhibitor peptides.
T-20 has fast track designation from the FDA in the U.S. for the treatment of
HIV-infected individuals. Fast track is granted to facilitate the
development and expedite the review of applications for drugs that are
intended to treat serious or life-threatening disease and that demonstrate
the potential to address an unmet medical need.
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