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TMC114 Expanded Access Program
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Tibotec Pharmaceuticals issued a press release announcing positive Phase IIb results for two of its investigational HIV drugs, TMC114, a protease inhibitor (PI), and TMC125, an NNRTI at ICAAC. Below is a summary of the release.
TMC114 POWER 2 study of treatment experienced patients with PI resistance: Data from the phase IIb 24-week primary efficacy and safety analysis showed that 62 percent of patients achieved a reduction in viral load of 1 log10 or more in the highest dose group compared to 14 percent in the control group. 39 percent of patients in the highest TMC114/r dose group reached undetectable virus levels (<50 copies/ml) compared to 7 percent in the control arm. This data, along with 24-week data from the POWER 1 study, will be submitted to the U.S. FDA for approval shortly.
Expanded Access Program (EAP) for TMC114: Tibotec opened an EAP in the U.S. in October and is now rolling out the program across Europe in order to provide access to TMC114 for HIV patients who need the compound and are not eligible for Tibotec clinical trials. Healthcare professionals and people living with HIV/AIDS who are interested in learning more about the program may email TMC114-C226@i3research.com or visit www.tibotec.com or www.clinicaltrials.gov.
TMC125 Phase IIb trial of treatment experienced patients with NNRTI resistance: Results from the 24-week primary endpoint showed activity against NNRTI resistant virus. The mean change from baseline in viral load was -1.04, -1.18 and -0.19 log10 copies/ml in the TMC125 400 and 800 mg bid and active control groups, respectively.
find pasted below the press release issued today. Feel free to contact me directly if you have any questions.
Tibotec Presents Phase 2b Data on 2 Investigational HIV Compounds at ICAAC
19 December 2005
08:00
PR Newswire Europe
- TMC114 and TMC125 Demonstrate Activity Against Drug Resistant HIV
Tibotec Pharmaceuticals Ltd. presented the primary 24-week efficacy and safety results from the POWER 2 trial on TMC114, a protease inhibitor (PI), in treatment-experienced patients and the first long-term clinical results of TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI) in HIV-1 patients with NNRTI resistance - at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held December 16 - 19 in Washington DC. Both TMC114 and TMC125 are currently being studied in phase 3 trials.
TMC114 phase 2b data in treatment-experienced patients
Data presented were from the 24-week primary efficacy and safety analysis of the POWER 2 study which is a randomized trial of TMC114 boosted with ritonavir (TMC114/r) in patients with experience of at least 1 PI, 1 NNRTI and 1 NRTI and had 1 or more primary PI mutations. The results showed that 62% of patients achieved a reduction in viral load (plasma HIV RNA) of 1 log10 or more in the highest TMC114/r dose group, 600mg/100mg BID, compared to 14% in the control group. A total of 278 patients were randomized to receive optimized background regimen (OBR) plus one of four doses of TMC114/r (400mg/100mg QD; 800mg/100mg QD; 400mg/100mg BID; 600mg/100mg BID) or OBR plus investigator-selected control PI(s).
At 24 weeks, the percentage of patients reaching undetectable virus levels (<50 copies/ml) was 39% in the highest TMC114/r dose group compared with 7% in the control arm. This study will continue to 144-weeks. Based on the 24-week results from POWER 1 and POWER 2, the selected dose for treatment-experienced patients in phase III trials is TMC114/r 600mg/100mg BID.
"These preliminary results in these treatment-experienced patients with highly resistant virus are encouraging," said Dr. Timothy Wilkin, Cornell University, New York, NY who presented the data at ICAAC. "The reduction in viral load observed in this trial demonstrated the antiviral activity of TMC114, and the accompanying rise in CD4 cells is clinically meaningful."
The most common treatment-emergent adverse events (AEs) were headache and nausea, which were each 17% across all TMC114/r arms compared with 17% and 9% respectively in the control arm. Overall, 15% of TMC114/r and 8% of control patients reported at least one serious AE (SAE). TMC114 boosted with low-dose ritonavir (TMC114/r) is in phase 3 clinical trials in both treatment-experienced and treatment-naive HIV-1 infected patients.
Expanded Access Program for TMC114
The expanded access program (EAP) for TMC114 opened in the US in October and is now rolling out across Europe. The program will provide access to TMC114 for HIV-1 infected patients who need the compound to construct a viable treatment regimen and who are not eligible for Tibotec clinical trials.
The TMC114 EAP is available to HIV-1 infected adults, at least 18 years old, who have limited or no treatment options due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced with at least two PI-based regimens, and have a CD4 cell count of equal or less than 200 cells/mm3. For more about the program, healthcare professionals and people living with HIV/AIDS may obtain information by emailing TMC114-C226@i3research.com or visiting www.tibotec.com or www.clinicaltrials.gov
TMC125 shows activity against NNRTI-resistant virus
TMC125-C223 was a phase 2b dose-ranging, randomized, partially-blinded study in HIV-1 infected patients with substantial treatment experience and documented evidence of NNRTI resistance and 3 or more PI mutations. The mean change from baseline in viral load was -1.04, -1.18 and -0.19 log10 copies/ml in the TMC125 400 and 800 mg bid and active control groups, respectively. A total of 199 patients were included in the analysis in a 2:2:1 ratio respectively. In these patients with NNRTI resistance, the viral load reduction in patients receiving TMC125 in combination with an optimized background regimen (OBR) was significantly greater than in the active control at the 24-week primary endpoint (p<0.05).
The most common adverse events (AEs) were diarrhoea and rash which were each 20% for the TMC125 groups compared with 15% and 8% for the active control group. Overall, 23% of TMC125 and 18% of control patients reported at least one SAE; 4 SAEs were classified as possibly related to TMC125.
The pivotal phase 3 clinical trial program for TMC125 opened last month and comprises two randomized, placebo-controlled trials in treatment-experienced HIV-1 infected adult patients with documented NNRTI resistance and at least 3 primary PI mutations. The two clinical trials of 600 patients each will be carried out in 18 countries. In these studies, the background protease inhibitor (PI) will be Tibotec's investigational PI, TMC114. This will be the first time that two new investigational antiretrovirals have been studied together in combination in heavily treatment experienced patients.
Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and superior anti-infectives for diseases of high unmet medical need.
For further information, please visit: www.tibotec.com
Tibotec Pharmaceuticals Ltd
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