Myriad
Pharmaceuticals Initiates Phase 2b
Study of MPC-4326 in a Genetically-Identified
Responder Population
Salt
Lake City -- December 1, 2009 -- Myriad Pharmaceuticals
Inc. (Nasdaq:MYRX) today announced the initiation
of a Phase 2b study of MPC-4326, a first-in-class,
small molecule inhibitor of HIV-1 maturation.
This
multicenter, randomized, open-label study is
designed to determine MPC-4326 efficacy in an
optimized background regime. The study participants
will be experienced HIV-1 infected individuals
who are failing current therapy and have documented
resistance to at least one agent in each of
the 'classic' three ARV [antiretroviral] classes
(NRTI, NNRTI, PI). The study will utilize the
new tablet formulation of MPC-4326 and will
test two doses of the experimental therapy.
The
primary objective of this study is to determine
viral suppression in the drug treated cohorts
at 24 weeks. In addition this trial will determine
time to viral suppression and assess the safety
and tolerability of MPC-4326 in combination
with a two-to-three drug optimized ARV therapy.
This
phase 2b trial will further assess and refine
a potential companion diagnostic -- a simple,
rapid and inexpensive assay to determine viral
genotype in HIV-1 infected patients. The study
protocol includes the use of a pre-specified
model of HIV-1 Gag polymorphisms to predict
MPC-4326 response. Viral genotype will be one
of the inclusion criteria used in identifying
study participants.
"We
are pleased to announce the advancement of the
clinical development of MPC-4326," said
Dr. Adrian Hobden, President and CEO of Myriad
Pharmaceuticals. "In addition, we look
forward to further evaluation of a companion
diagnostic that could be used to identify those
individuals who would have the greatest benefit
from MPC-4326. It is a distinct advantage to
patients and physicians to have the ability
to identify in advance those who will respond
to a given drug."
About
MPC-4326
MPC-4326
is being developed by Myriad Pharmaceuticals,
Inc. for the oral treatment of HIV-1 infection.
MPC-4326 is the first of a class of antiretroviral
(ARV) drug candidates that inhibit HIV-1 replication
by interfering with the maturation of the HIV-1
virus. Specifically, MPC-4326 interferes with
the last step in the processing of the HIV-1
Gag protein. This inhibition leads to formation
of noninfectious, immature virus particles,
thus preventing subsequent rounds of HIV infection.
As expected for a novel mechanism of action,
MPC-4326 retains inhibitory activity against
HIV-1 isolates resistant to the four classes
of currently approved drugs commonly used by
HIV infected patients: NRTIs, NNRTIs, protease
inhibitors and fusion inhibitors. No cross-resistance
has been observed.
Over
675 subjects, including over 180 HIV-infected
individuals, have been studied in clinical trials
of MPC-4326. Results from these trials have
shown MPC-4326 to be well-tolerated and have
demonstrated significant and clinically relevant
reductions in viral load in a subset of HIV-infected
patients representing approximately 60-70% of
HIV-infected patients. This "responder"
population can be identified by a simple, rapid
and inexpensive assay of the HIV virus. In a
Phase 2 clinical trial completed in 2008, MPC-4326
met its primary objective by demonstrating viral
reduction in HIV-positive. In addition, the
safety profile of MPC-4326 was comparable to
earlier studies where that profile had been
similar to placebo.
About
Myriad Pharmaceuticals, Inc.
Myriad
Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on discovering, developing,
and commercializing novel small molecule drugs
that address severe medical conditions, including
cancer and HIV infection. Our pipeline includes
clinical and pre-clinical product candidates
with distinct mechanisms of action and novel
chemical structures that have the potential
to be first-in-class and/or best-in-class therapeutics.
For
more information visit www.myriadpharma.com.
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