BUENOS AIRES (July 11, 2001) - Data evaluating patient
acceptance of the subcutaneous administration of T-20, an
investigational HIV fusion inhibitor being developed jointly by
Roche and Trimeris (Nasdaq: TRMS), are being presented today at
the First International AIDS Society (IAS) Conference on HIV
Pathogenesis and Treatment in Buenos Aires, Argentina. These
data, collected in a substudy of the T20-205 Phase II clinical
trial, suggest that subcutaneous delivery of T-20 was
well-accepted by patients over the 48 week observation period.
Additional data from a different Phase II study, T20-208,
presented in a late breaker poster session, indicate that T-20
can be administered via subcutaneous injections delivered as
one 90 mg dose twice daily, rather than by two twice-daily
injections, which were used in earlier clinical studies.
"Two of the biggest challenges facing patients with HIV are
adherence to therapy and resistance. It is critically
important to develop new antiretroviral agents that have the
potential to treat patients with extensive resistance, and
identify medications that will be tolerated over the long
term," said Cal Cohen, M.D., research director, Community
Research Initiative in Brookline, Massachusetts. "We are very
pleased to report that the patients in this year-long trial, on
average, did not view subcutaneous delivery of T-20 as
interfering with daily life."
This substudy was conducted to assess whether subcutaneous
administration of T-20 would influence a patient's ability to
conduct normal activities of daily living (ADL). A total of 55
patients completed written surveys evaluating the impact of
drug delivery on their ability to perform ordinary ADL prior to
initiating therapy and at 48 weeks or at their last study
visit. Assessment of ADL was based on established survey
instruments with questions added to assess HIV-specific issues,
including privacy and sexuality. Patients also rated issues
such as ease of injection, medication storage and
reconstitution, as well as disposal of needles.
Eighty-five percent of patients rated the procedure of
injection as "very easy/easy" or "not bad." Sixty two percent
of patients "somewhat agreed" or "strongly agreed" with the
statement that "relative to my other HIV/AIDS drugs,
subcutaneous injections have not" limited ADL. Over 75 percent
of patients agreed with each of the statements that moderate
activities (96 percent), preparing meals (95 percent), vigorous
activities (91 percent), family life (89 percent), social
relationships (87 percent), performance of work (78 percent)
and intimacy (76 percent) had not been affected by the
treatment regimen.
More About the Substudy
When asked about issues of refrigeration, reconstitution and
disposal of needles, patients rated each procedure on a scale
of one (very difficult) to five (very easy), with mean scores
of 3.8, 3.4 and 4.4, respectively. Of patients completing 48
weeks of treatment, 98 percent stated that, if offered, they
would choose to continue with twice-daily subcutaneous
injections of T-20. Of those patients who withdrew prematurely
for any reason, 85 percent would have chosen to continue
treatment with T-20.
In addition, over half of patients agreed with each of the
statements that subcutaneous injections had not affected the
general performance of daily activities (62 percent), personal
appearance (62 percent), health privacy (62 percent) or ability
to travel (54 percent).
T20-205 was a Phase II, open-label, single-arm clinical trial
conducted to assess the safety of T-20 via twice-daily
subcutaneous injection in combination with other anti-HIV drugs
in patients with extensive prior treatment experience and who
had previously received T-20 in other studies. Of the 70
patients treated with T-20, 97 percent had been previously
treated with a protease inhibitor and 79 percent had been
treated with all three existing classes of antiretrovirals.
Patients had received an average of over nine prior anti-HIV
drugs.
The most common adverse event related to T-20 in the T20-205
trial was injection site reactions. However, no patients
discontinued due to these events. In clinical studies to date,
including this trial, the most common adverse events observed
with T-20 were mild to moderate in severity. The most frequent
adverse events include injection site reaction, headache,
nausea, fever, increased energy levels, asthenia, diarrhea, and
dizziness, although a causal relationship to T-20 cannot be
established for some of these events.
More About Fusion Inhibitors
This new class of investigational anti-HIV drugs known as
fusion inhibitors belongs to a broader category of
investigational drugs known as "entry inhibitors," all of which
work in various ways to block the HIV virus before it enters
and takes over a host cell. Classes of drugs within the entry
inhibitor category include attachment inhibitors, chemokine
coreceptor inhibitors and fusion inhibitors. Led by T-20, the
fusion inhibitors are the furthest along in development in the
entry inhibitor category. Fusion inhibition takes place after
HIV attaches to a host cell to prevent the virus from fusing
with the cell and taking it over.
Both T-20 and T-1249, the second-generation fusion inhibitor,
have received fast-track designation by the U.S. Food and Drug
Administration (FDA) for the treatment of HIV-infected
individuals. Fast track is granted to expedite the development
of products that may provide a significant improvement in the
safety or effectiveness of the treatment for a serious or
life-threatening disease.
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 interest 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:
http://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, T-20, 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 Web
site 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, 2000, filed with the Securities and Exchange
Commission on April 2, 2001.