Asia PR News

CO CORK, Nov. 29 /PRNewswire-AsiaNet/ –

Phase III Registration Studies Continue

Tibotec Pharmaceuticals Ltd. announced today the discontinuation of a
single exploratory open-label phase II study involving TMC125, a non-nucleoside
reverse transcriptase inhibitor (NNRTI). Discontinuation of this study has no
impact on the phase III registration studies of TMC125, which are currently
enrolling in highly treatment-experienced patients. The trial design, the
patient population, the formulation of TMC125 and the background regimen of
these trials are substantially different from that of the discontinued study.

The discontinued study, TMC125-C227, involved protease inhibitor (PI)-naive
patients failing a first line non-nucleoside reverse transcriptase inhibitor
(NNRTI)-containing regimen. Patients were randomized to receive either TMC125
or a protease inhibitor and the background regimen was limited to two
nucleoside reverse transcriptase inhibitors (NRTIs).

Data collected after 12 weeks of therapy show that there is a difference in
the proportion of patients achieving or maintaining an undetectable viral load
in favor of the control group, which received PI-based therapy. In contrast to
data recently presented at the European AIDS Conference (EACS) in Dublin, the
virologic response of some patients receiving TMC125 was suboptimal (1). In
this trial, undetectable viral load is defined as less than 50 copies/ml. No
safety concerns were identified. The company decided to stop the trial based on
these data; the study’s Data Safety Monitoring Board endorsed that decision.

Further analyses will be conducted to investigate potential explanations
for and causes of the lower response in patients receiving TMC125 in this
study, including resistance at baseline, activity of the supporting dual
nucleoside analogue backbone, and plasma levels of TMC125.

To minimize the chances of compromising future treatment options, Tibotec
researchers believe that it is in the best interest of patients involved in the
study, including those presently responding to TMC125 therapy, to be switched
to a regimen based on approved antiretrovirals as soon as possible. The Company
will be providing patients, investigators, ethics committees and regulatory
authorities with currently available information.

Given the antiviral activity demonstrated with TMC125 thus far in studies
involving patients with NNRTI-resistant virus, Tibotec researchers are
confident in the design and conduct of the phase III trials, TMC125-C206 and
TMC125-C216 (DUET 1 and DUET 2), which are currently enrolling patients.

Tibotec Pharmaceuticals Ltd
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical
research and development company. The Company’s main research 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: http://www.tibotec.com

(1) Nadler et al. Efficacy and Tolerability of TMC125 in HIV patients with
NNRTI and PI Resistance at 24 weeks: TMC125-C223. Abstract no. LBPS3/7A

SOURCE: Tibotec Pharmaceuticals Ltd.

CONTACT: Karen Manson,
Tibotec,
mobile: +32-479-89-47-99

Web site: http://www.tibotec.com