T-20 also shows improved immune response
Barcelona, Spain, July 8 � Today world renowned HIV experts unveiled positive results from two large scale international studies with T-20, the furthest in clinical development of a new class of investigational antiretroviral drugs called "fusion inhibitors". Phase III results presented for the first time, show that levels of HIV in the blood are significantly reduced when the ground-breaking investigational HIV drug, T-20 is used with optimised background therapy (individually chosen anti-HIV drug combination selected from those currently available). The body�s immune response is also significantly improved in these treatment experienced patients.
Unlike existing AIDS drugs which work once the HIV virus has entered the human cell, T-20 works in a completely new way in that it blocks HIV from entering CD4 cells of the immune system.
The addition of T-20 on top of conventional optimised therapy is expected to become a key treatment component helping physicians optimise therapy in previously treated HIV patients, as it helps the body�s immune cells (CD4 cells) from further depletion by facilitating the reduction of the amount of HIV virus in the blood that can destroy these cells.
"The design of these large studies was unusual in that they specifically included heavily pre-treated HIV patients who were running out of treatment options." said Dr Bonaventura Clotet, Head of HIV Section, Hospital Germans Trias i Pujol, Barcelona and a leading investigator in the TORO 2 study.
"For us to then observe twice the percentage of patients achieving a reduction in their viral load below detectable levels in the study arms that contained T-20 in comparison to the study arms that only contained the currently available antiretrovirals is remarkable and far better than anyone had expected."
Results
A thousand patients across 112 centres worldwide were enrolled in the large scale Phase III studies, known as TORO 2* (T-20 versus Optimized Regimen Only) and TORO 1. At 24 weeks, primary and secondary analysis results consistently showed that T-20, administered in combination with an optimised antiretroviral treatment regimen, provides a highly significant decrease in the amount of virus in the blood with twice as many patients achieving a reduction in their viral load below detectable levels in the study arms that contained T-20 in comparison to the study arms that only contained the currently available antiretrovirals. Also the body�s immune response (an increase in CD4 immune cells) was consistently and significantly improved in T-20 containing study arms compared to an optimised antiretroviral treatment regimen alone.
In both international studies the agreed primary end point, a difference in the magnitude of decrease in HIV between the two arms at 24 weeks, was statistically significant (TORO 1 - difference = 0.93, p<0.0001 and TORO 2 � difference=0.78, p< 0.0001). Secondary end point results include:
- In TORO 1, 37% of T-20 recipients achieved a reduction in their viral load below detectable levels (<400 copies/mL) after 24 weeks whereas 16% of patients on optimised therapy alone achieved non detectable levels of viral RNA (p< 0.0001).
- In TORO 2, 28% of T-20 recipients achieved a reduction in their viral load below detectable levels (<400 copies/mL) after 24 weeks whereas 14% patients on optimised therapy alone achieved non detectable levels of viral RNA (p =0.0001).
- In TORO 1 the average immune cell count in the T-20 containing regimens after 24 weeks was increased by 76 immune (CD4) cells per cubic millimetre of blood compared to 32 cells per cubic millimetre in the group who did not receive T-20 (p< 0.0001).
- In TORO 2 the average immune cell count in the T-20 containing regimens after 24 weeks was increased by 65 immune (CD4) cells per cubic millimetre of blood compared to 38 cells per cubic millimetre in the non T-20 containing arm (p= 0.023).
Tolerability
T-20 was shown to be well-tolerated and twice-daily, subcutaneous administration of the drug was well accepted. While almost all (98%) patients on the T-20 arms of both TORO 1 and TORO 2 experienced injection site reactions, no more than 3.3% of patients in either study discontinued the treatment due to these reactions.
"Today a line has been drawn in the sand" said Dr. Bonaventura Clotet. "The T-20 TORO 1 and 2 studies have redefined the standard of care for pre-treated patients".
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 a further 450 adults and was recently expanded to include 50 children and adolescents. The study is ongoing and is being conducted in Australia, Brazil, Europe and North America. Roche and Trimeris remain on track to commence T-20 Early Access Programmes in this second half of 2002 when increased drug supply is expected to become available and will announce the full details of the programmes before the end of August. Roche is proceeding with filing registration packages for T-20 in the EU and US early in the second half of this year.
Editors' Note:
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.
Optimised background therapy
Optimised background therapy consists of an individually chosen anti-HIV drug combination selected from currently available drugs. The TORO studies demonstrate a significant additional reduction in HIV when T-20 is used with optimised background therapy, compared to an optimised background therapy alone.
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, 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.
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, 2001 filed with the Securities and Exchange Commission on March 25, 2002.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world�s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche�s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people�s well-being and quality of life. For more information on Roche and its commitment to research in HIV, visit the: roche-hiv.com website. All trademarks used or mentioned in this release are legally protected.
For more information, or if you would like to interview a patient or physician or would like B-roll or images, please contact:
Alexander Watson
Ketchum , London
On Site Mobile: + 44 7712 675 990
Telephone: + 44 20 7611 3663
E-Mail: alexander.watson@ketchum.com
Maria Vigneau
Roche, Basel
On Site Mobile: + 41 79 506 9941
Telephone: + 41 61 688 9291
E-Mail: maria.vigneau@roche.com
|
