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Roche and Trimeris Open Physician Enrollment For Fuzeon(TM) U.S. Early Access
Program
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NUTLEY, N.J. and DURHAM, N.C., Aug. 16. Responding to patient need, Roche
and Trimeris today announced that physician enrollment for the U.S. Early
Access Program for Fuzeon(TM)* (enfuvirtide), formerly known as T-20, will
open on Monday, August 19. This program, running parallel with other
controlled Fuzeon clinical trials, will make Fuzeon available in the near
term for a limited number of additional patients with advanced HIV disease.
Study drug will be made available across all participating countries,
including the U.S. and Europe, beginning in early October.
Fuzeon is the most clinically advanced in an investigational class of HIV
drugs known as fusion inhibitors. Unlike existing anti-HIV drugs, which
target viral enzymes involved in replication of the virus, Fuzeon is designed
to block HIV from fusing with a host cell. Data from two large,
internationally conducted Phase III trials, presented at the XIV
International AIDS Conference in Barcelona, indicate that patients on
combination therapy with Fuzeon were twice as likely to achieve undetectable
levels of HIV in the blood. Fuzeon also provided a significant increase in
immune cells at 24 weeks, as compared to those patients who received
combination therapy without Fuzeon. Link to NATAP report from Barcelona about
these T-20 studies and the results:
www.natap.org/2002/barcelona/day1.htm
Entry Criteria for the Early Access
Until the final scale-up of a complex manufacturing and production process
for Fuzeon is completed, supplies will remain limited. Consequently, the
Fuzeon Early Access Program protocol has been designed for patients with
advanced HIV. Specifically, patients must be HIV-1 infected adults or
adolescents, older than 16 years of age, with an HIV-1 RNA viral load greater
than 10,000 copies/mL and CD4 lymphocyte count of less than 100 cells/mm3.
Patients must have limited treatment options among currently commercially
available agents, per the judgment of the investigator.
Patients will be enrolled in the U.S. Fuzeon Early Access Program through
physicians only. Patients enrolled in this program will be tracked for drug
safety. Physicians can visit http://www.T20EAP.com for more information on
the U.S. program and to register to participate in the program. This website
may be accessed beginning on Monday, August 19, 2002.
Upon successful completion of all required regulatory documentation,
contracts and the site initiation visit, physicians may be able to enroll up
to five patients, depending upon the number of patient slots available, as
patient enrollment progresses during this program. The interim between the
opening of the registration process and drug availability will allow
physicians to have sufficient time to complete all the required documentation
and arrange for their participation in an investigator and study coordinator
program.
More About Fuzeon
Fuzeon, a peptide fusion inhibitor, is administered as a twice-daily
subcutaneous injection. In Phase III clinical trials through 24 weeks,
overall clinical adverse events aside from injection site reactions were
similar between the Fuzeon and control groups. Other adverse events
occurring in more than 10 percent of the patients and occurring more
frequently in the Fuzeon group were fatigue, insomnia, and peripheral
neuropathy. It was not possible to establish a causal relationship between
these other adverse events and Fuzeon. In the first Phase III study, the
incidence of Grade 3 and 4 laboratory abnormalities was similar between the
Fuzeon and control arms. In the second, Grade 3 laboratory abnormalities
were more frequent in the Fuzeon group, and Grade 4 laboratory abnormalities
were more frequent in the control group. While most patients in the Fuzeon
arms of both studies experienced injection site reactions, only three percent
of patients discontinued the studies as a consequence.
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 Fuzeon, the first
member of a new class of investigational anti-HIV drugs known as fusion
inhibitors. Fuzeon is the furthest along in clinical development in the
entry inhibitor class. Unlike existing AIDS drugs that work inside the cell
and target viral enzymes involved in the replication of the virus, Fuzeon
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.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
prescription drug unit of the Roche Group, a leading research-based health
care enterprise that ranks among the world's leaders in pharmaceuticals,
diagnostics and vitamins. Roche discovers, develops, manufactures and
markets numerous important prescription drugs that enhance people's health,
well-being and quality of life. Among the company's areas of therapeutic i
nterest are: dermatology; genitourinary disease; infectious diseases,
including influenza; inflammation, including arthritis and osteoporosis;
metabolic diseases, including obesity and diabetes; neurology; oncology;
transplantation; vascular diseases; and virology, including HIV/AIDS and
hepatitis C. For more information on the Roche pharmaceuticals business in
the United States, visit the company's Web site at: www.rocheusa.com
About Trimeris, Inc.
Trimeris is a development stage, biopharmaceutical company engaged in the
discovery and development of novel therapeutic agents that block viral
infection by inhibiting viral fusion with host cells. Trimeris' lead product
candidate, Fuzeon, which inhibits fusion of the human immunodeficiency virus
(HIV) with host cells, is currently in Phase III clinical trials and has
received fast track designation from the FDA. Trimeris' second fusion
inhibitor product candidate, T-1249, which also inhibits HIV fusion, has
received fast track designation from the FDA and is in Phase I/II clinical
testing. For more information on Trimeris, Inc., visit the company's website
at www.trimeris.com
Trimeris Safe Harbor Statement
Note: Except for any historical information presented herein, matters
presented in this release are forward-looking statements that involve risks
and uncertainties. The results of Trimeris' previous clinical trials are not
necessarily indicative of future clinical trials, and future results could
differ materially from the results presented herein. Factors that could
cause or contribute to such differences include, but are not limited to,
those discussed in the "Risk Factors" section included in Trimeris' Form 10-K
for the year ended December 31, 2001 filed with the Securities and Exchange
Commission on March 25, 2002.
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