(Los Angeles, CA) --
The
HIV gene medicines company Calimmune announced
today
that
the
first patient
has
begun treatment in
a Phase I/II
clinical trial designed
to determine
whether a pioneering genetic medicine approach can help to protect
individuals infected with
HIV from the effects of
the
virus. The study, “Safety Study of a Dual
Anti-HIV Gene Transfer Construct to Treat
HIV-1 Infection,” utilizes a gene medicine
called Cal-1, developed in the
lab
of Nobel
Laureate Dr. David
Baltimore and
by Calimmune.
In the
study, 12 HIV-positive participants will
be infused
with their
own
T cells and stem
cells (hematopoietic stem cells,
HSC), which have
been modified to
block the
HIV
receptor CCR5, and to prevent HIV fusion. The procedure
is designed to prevent the
virus from entering and damaging
protected
cells. The dual
approach used in
the study
is
designed to reduce the
possibility that HIV
can develop resistance to the
procedure.
The goal of the study is to
assess the safety, feasibility, and
tolerability of Cal-1
in HIV- infected
individuals who have previously been
on highly active antiretroviral therapy
(HAART) but
are not currently taking
any
antiretroviral agent. In addition to
routine
clinical and laboratory assessments to monitor general health
and HIV infection, the
study will
monitor the presence
of Cal-1
protected cells in
various
cell types in the blood and
lymphoid
tissue. Other analyses
will monitor the safety of Cal-1. The first patient was
treated in the study in
late
June. Data from
this study are expected in 2015.
All participants in the study’s three arms will
receive
the Cal-1 gene transfer.
Participants in
two
of the three study arms will
also
receive different doses of a preconditioning drug known as busulfan,
which
may
make the
therapy more effective.
“This study is an early but important step in an emerging area of scientific exploration,
representing the culmination of more than a
decade of research and
development,”
said Calimmune Chief Executive Officer Louis Breton. “We are optimistic
that
what we
learn from this study may bring
us closer to the day when a one-time treatment
could provide an alternative to
a lifetime
of antiretroviral therapy.”
The study has been partially funded by the California Institute for Regenerative Medicine (CIRM). The study will take place at clinical trial
sites
in Los Angeles
and San Francisco,
Calif., under the
direction of Principal Investigators Ron Mitsayasu, M.D.,
of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research.
For more information, visit www.clinicaltrials.gov.
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