California stem cell agency today scored what it called an “important
milestone” with the announcement of the start of a clinical trial
involving a therapy to help protect persons infected with HIV from
the effects of the virus.
trial is partially funded from a $20 million award from the stem cell
agency, which is known as CIRM, to researchers
at UCLA and Calimmune, a Tucson, Az.,
company. Calimmune's share of the award was $8.2 million.
Trounson, president of the $3 billion state agency, said in a
statement,
“CIRM
funding of this Phase l/ll trial is an important milestone for us.
One of our goals is to support research that moves the most promising
science out of the lab and into clinical trials in people. To be able
to do that with a disease as devastating as HIV/AIDS highlights the
importance of our funding and the potential impact it could have on
the health of people around the world.”
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.”
served on the CIRM board from 2004 until June 6, 2007. He resigned
from the board about
18 months before the application process began for the grant round
that ultimately funded Calimmune, a company he helped to found. He is currently chairman of the Calimmune board.
for comment, Jeff Sheehy, a member of the CIRM governing
board and communications director for AIDS research at UC San
Francisco, said,
"This
trial will hopefully offer several important insights into the safety
and feasibility of genetically modifying blood forming stem cells in
an HIV patient as a potential therapy. We are very early in
this research, and with this Phase I trial's goal of establishing
safety and the risks involved, I applaud the courage and altruism
demonstrated by the patients who are willing to participate in this
study."
press release said
the principal investigators on the clinical trial are Ron
Mitsayasu of
UCLA and Jacob
P. Lalezari of Quest
Clinical Research of
San Francisco. Quest is currently soliciting patients for the
clinical trial as well as UCLA. (Persons interested in participating
in the trial can find email contacts at
this website.
Twelve are needed.)
principal investigators on the CIRM award are Irvin Chen of
UCLA and Geoff Symonds of Calimmune.
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