On a more positive note, from Barcelona, Spain, re new treatments for HIV sufferers:
As well as the Vaxgen vaccine, (currently undergoing late stage testing in Thailand)
a new treatment, T20 Z(in clinical trials), also got mentioned as a
promising therapy. T20 is being developed by Roche and Trimeris (NASDAQ ticker TRMS).
Unfortunate to note that T20 is in Phase II and gets all this publicity and there is no
mention of WF10 in news reports.
Incidentally, Trimeris has a NAS. market valuation of 750million US$.
This US market maker we need to float on the NAS. sure needs a lot of blood money. I can understand the frustration of anybody who feels small investors are treated badly , yet again in 'the game' of getting in to the big league.
Fox.
Trimeris, Inc., company's web site at www.trimeris.com.
T-20 IN COMBINATION THERAPY ACHIEVES
VIRAL SUPPRESSION AND IS WELL-TOLERATED
OVER 48 WEEKS
-- Results from Two Phase II Trials of T-20, First Investigational
HIV Fusion Inhibitor, among Treatment-Experienced Patients --
Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced 48-week results from two Phase II
clinical trials evaluating T-20, the furthest in clinical development of an investigational class of
antiretrovirals called fusion inhibitors. The results, to be presented at an upcoming scientific
conference, indicate that T-20 contributes to the suppression of plasma viral load and is well
tolerated over the course of nearly a year as part of antiretroviral combination therapy. The
T20-208 study assessed the pharmacokinetics, safety, tolerability and antiviral activity of
high-strength formulations of T-20 in combination with oral antiretrovirals among patients with
advanced HIV disease and prior exposure to all three classes of available antiretrovirals. The
T20-206 study compared the tolerability and antiviral activity of combination therapy with T-20
to a fixed background regimen in a more moderately treatment-experienced patient population
(patients not previously exposed to non-nucleoside reverse transcriptase inhibitors, or
nNRTIs).
"These two trials round out our Phase II experience with T-20. We are very pleased that T-20
continues to demonstrate consistent trends in activity and tolerability now over a duration of
48 weeks," said David Reddy, Franchise Leader and Disease Area Strategy Head-HIV/AIDS,
Roche Pharmaceuticals. "We are looking forward to the results of our two large, pivotal Phase
III trials to evaluate the safety and efficacy of T-20. It is anticipated that the results from the
24-week endpoint will serve as the basis for our regulatory submissions in the U.S. and
Europe in the second half of this year."
T20-208: Formulation Comparison Study in Heavily Treatment-Experienced Patients
Forty-six triple-class, treatment-experienced patients participated in T20-208, a formulation
comparison study of T-20. Patients in the trial had advanced disease with prior exposure to all
three classes of available antiretrovirals, an average HIV-RNA level of 5.37 log10 copies/mL
and an average CD4+ cell count of 24
cells/m l.
"After long term treatment (48 weeks), half (23 of 46) of the triple-class experienced patients
who used T-20 in combination therapy had their viral loads reduced beneath the limit of
detection of the Roche AMPLICORÒ viral load assay (<400 copies/mL). This is an impressive
result for this growing and difficult to treat population," stated Dr. Joseph Wheat, Professor of
Medicine, Indiana University School of Medicine, Division of Infectious Diseases. "We are also
delighted to see that virtually all patients in the study (93 percent of 46 patients) completed a
full year of treatment, indicating that long term treatment with T-20 administered
subcutaneously twice-daily is tolerable and acceptable to these patients."
Furthermore, the results support the development of T-20 in Phase III trials at two injections
per day. Injection site reactions were the most frequent adverse event; all patients
experienced at least one event, but none discontinued the study due to an injection site
reaction. Only three patients (6.5 percent) had discontinued participation in the study at 48
weeks.
T20-206: First Controlled Study of T-20 in Combination with Oral Antiretrovirals
Forty-eight week results of T-20 in combination with oral antiretrovirals suggest that the
addition of T-20 to a standard antiretroviral regimen was well tolerated and provided additional
decreases in plasma viral load than that provided by the antiretroviral control regimen alone.
In the strict intent-to-treat, missing equals failure analysis, 55 percent of patients (28 of 51) in
the combined T-20 arms achieved undetectable HIV-RNA levels of less than 400 copies/mL,
and 47 percent (24 of 51) reached the lower threshold of HIV-RNA levels of less than 50
copies/mL. In the control group, 37 percent of patients (seven of 19) achieved HIV-RNA levels
of less than 50 copies/mL and 400 copies/mL. CD4+ cell count increases were also higher in
patients treated with T-20 containing regimens – 132 cells cells/m l compared to 90 cells/m l in
the control group.
"We are pleased to report that T-20 was shown to contribute to the activity of a conventional
combination regimen and was an acceptable therapy to most patients over 48 weeks," said Dr.
Jacob Lalezari, Director of Quest Clinical Research Institute, San Francisco. "As in previous
studies, those receiving T-20 demonstrated enhanced virologic and immunologic responses
above the oral ARV regimen alone, although this time in patients with less advanced disease
and less previous antiretroviral drug experience".
T20-206 was an open label, randomized Phase II controlled study of T-20 comparing three
doses of T-20 in combination with a regimen of oral antiretrovirals (abacavir, amprenavir,
ritonavir and efavirenz) in 71 nNRTI-naïve and protease inhibitor (PI)- and nucleoside reverse
transcriptase inhibitor (NRTI)-experienced HIV patients. Patients were enrolled in one of four
treatment groups: control regimen without T-20 (arm A) or control regimen with either 50 mg,
75 mg, or 100 mg of T-20 given subcutaneously twice daily. This Phase II study was not
designed to show differences among treatment arms.
There was no increase in adverse events between those patients in the control arm and those
patients receiving T-20. Approximately two-thirds of patients taking T-20 experienced local
reaction at the site of injection, but only three patients experienced sufficient discomfort to
discontinue treatment.
More About T-20
T-20 is administered as a twice-daily subcutaneous injection. In all studies completed to date,
the most frequent side effect observed is a mild to moderate local skin reaction at the site of
the injection of T-20. Such reactions occur in nearly all patients, but are rarely severe or
cause the patient to discontinue treatment. Diarrhea, nausea, dizziness, fatigue, and
headache are other commonly reported side effects, although we are unable to establish
whether T-20 is the cause of these side effects.
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, 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 are planning 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 and T-1249, the first members 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, while T-1249 is
currently being evaluated 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, T-20 and T-1249
inhibit 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 and T-1249 have 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. |
