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TMC114 Protease Inhibitor Available Soon
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--TMC114 Expanded Access Program for People Living with HIV/AIDS to Begin Enrollment in Autumn of 2005
--Tibotec to file for accelerated approval for TMC114 in Early 2006 based on 24-week phase IIb study data reported at CROI 2005 in Feb. For the first time since indinavir in 1995, the FDA is accepting an accelerated approval application for an HIV antiretroviral drug; TMC114 for patients with HIV drug resistance & limited treatment options. The FDA has 6 months after the application is submitted to the FDA to review & respond. Here is a link to a full NATAP report on the study reported at CROI:
"TMC114/r in 3-Class Experienced Patients: 24-week interim analysis"
http://www.natap.org/2005/CROI/croi_07.htm
The study results were impressive. Presumably, the reason for the FDA's action is the impressive antiviral activity & safety of 114/r reported from the 24 week phase II study. Study patients had extensive treatment experience: used an average of 11 prior antiretroviral drugs, 4 PIs, 1 NNRTI, 5 NRTIs; patients had extensive PI resistance & on average 18 PI protease mutations. The TMC114/r dose of 600/100 twice daily will be used & with this dose in the study the mean viral load reduction after 24 weeks in the phase II study was 1.85 log; 72% of the patients in the study had >1 log viral load reduction; 47% of patients had achieved <50 copies/ml; for patients who used T20 & had never used T20 before, 67% had <50 copies/ml; for patients with 3 or more primary PI mutations, 48% using T20 plus 114/r had <50 copies. You can read the entire NATAP report at the link above.
--Starting Now for patients with advanced HIV & Drug resistance (CD4 <100, HIV Viral Load >10,000), the OPEN LABEL SAFETY STUDY for 600 patients will be at 30+ sites in USA and with comparable numbers of patients outside the USA. Further information and a listing of the study sites will be posted any day to the clinicaltrials.gov site. The Official Title of the study: Open-label safety study of TMC114 in combination with low dose RTV and other ARVs in highly experienced HIV-1 infected patients with limited or no treatment options.
Tibotec Inc released this Press Announcement
PRESS RELEASE
CONTACT:
Karen Manson
Tibotec
Cell +32 479 89 47 99
YARDLEY, Pa., U.S.A., June 14, 2005 - Tibotec, Inc. announced today it plans to initiate an expanded access program (EAP) for its investigational protease inhibitor, TMC114, in the autumn of this year for people with HIV/AIDS who need the compound to construct a viable treatment regimen. The company also announced that it plans to seek accelerated approval for TMC114 in the United States and Europe through regulatory submissions filed by early 2006 based principally on the 24-week primary analyses of the company's two phase IIB trials.
Initiation of enrollment into the expanded access program -- which will be for heavily treatment-experienced adults living with HIV/AIDS -- is contingent on the approval of local health authorities and recruitment of pivotal phase III trials. Expanded access programs provide people with severe or life-threatening illnesses with access to treatments currently being evaluated in clinical trials.
"We know that many people living with HIV/AIDS have run out of treatment options because of the increasingly significant issue of viral resistance, and we are working to provide them with access to TMC114 as soon as possible through this program," said Paul Stoffels, M.D., President of Tibotec.
TMC114 belongs to a class of antiretroviral agents known as protease inhibitors. Protease inhibitors are commonly used in combination with other classes of anti-HIV drugs to prevent the replication of HIV in the body.
The TMC114 expanded access program will be administered by local operating entities within Johnson & Johnson, and will be supported by i3 Research in the U.S. and Parexel outside the U.S. Pending local regulatory approvals, the product will be commercialized by Tibotec Therapeutics in the U.S. and Janssen-Cilag and other affiliates outside the U.S.
Data presented at CROI, Boston, February 22-25, 2005
Data from a 24-week combined interim analysis of the phase IIB trials of TMC114 were presented at the 12th Conference on Retroviruses and Opportunistic Infections (CROI). That analysis included two phase IIB (dose-finding), randomized trials of TMC114 boosted with ritonavir (TMC114/RTV) in patients with experience of at least three classes of antiretrovirals and with one or more primary protease inhibitor mutations. Patients in the highest dose group, 600mg/100mg BID, experienced a mean reduction in plasma HIV RNA of -1.85 log10, compared to a reduction of - 0.27 log10 in the control group. Patients were randomized to receive optimized background regimen (OBR) plus one of four doses of TMC114/RTV (400mg/100mg QD; 800mg/100mg QD; 400mg/100mg BID; 600mg/100mg BID) or optimized background regimen (OBR) plus investigator-selected control protease inhibitor(s). The interim analysis was performed after 150 patients had reached 24 weeks in each of the two studies; a total of 497 patients were included in the analysis.
After 24 weeks, the percentage of patients reaching undetectable virus levels (<50 copies/ml) ranged from 30% (lowest dose group) to 47% (highest dose group) in the TMC114/RTV arms, compared with 10% in the control arm. The most common adverse events were headache and diarrhea, which were 17% and 14% respectively across all TMC114/RTV arms compared with 23% and 20% in the control arm. These studies will continue to 144 weeks.
Based on these 24-week results, the selected dose of TMC114/RTV for treatment-experienced patients in phase III trials is 600mg/100mg BID. TMC114 will be studied in both treatment-experienced and -naïve patients in phase III trials.
Tibotec Inc., Janssen-Cilag and Tibotec Therapeutics are members of the Johnson & Johnson family of companies.
Tibotec, Inc.: Research & Development:
Tibotec, Inc., based in Yardley, Pa., is a pharmaceutical research and development company, with headquarters in Ireland and an operating affiliate in Belgium.
Tibotec is dedicated to the discovery and development of novel, new drugs for HIV/AIDS and other infectious diseases, with the ultimate aim of enhancing and extending peoples' lives.
Tibotec Therapeutics: US Sales & Marketing
Tibotec Therapeutics, a division of Ortho Biotech Products, L. P., is headquartered in Bridgewater, N.J., and is dedicated to delivering innovative oncology, virology and other specialty therapeutics that improve patients' survival and quality of life, and address serious unmet needs in the health care community.
Janssen-Cilag: European and ROW Sales & Marketing
The Janssen-Cilag companies are world leaders in traditional and biological medicines for conditions in many disease areas, including pain, mental health, neurology, oncology, hematology and nephrology. Ortho Biotech, the biopharmaceutical division of the Janssen-Cilag companies, markets medicines for nephrology, hematology and oncology.
For further information about Tibotec, please visit www.tibotec.com
For clinical trial information please visit www.clinicaltrials.gov
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