Cell Genesys To Start New Phase II AIDS Gene Therapy Trial
Dow Jones Newswires
NEW YORK -- In a move to determine the effects of
AIDS gene therapy on an expanded patient group, Cell
Genesys Inc. (CEGE) will conduct a second Phase II
AIDS gene therapy trial.
The Foster City, Calif., gene therapy company
announced Monday that it completed enrollment for the
40-patient multi-center study.
The goal of the new trial is to determine whether Cell
Genesys' gene therapy can reduce the levels of
HIV-infected cells in patients who have responded well
to antiretroviral drugs and no longer have detectable
HIV in their blood.
Up to this point, studies have been conducted only in
patients for whom antiviral drugs have failed to eradicate
HIV in the blood. About 60 patients with detectable
levels of HIV in their blood have been treated to date
using the company's AIDS gene therapy.
Cell Genesys' commercial approach to AIDS gene
therapy involves removing immune system cells, including
T cells, from a patient's blood through standard blood
bank procedures. The T cells are sent to the company's
manufacturing facility and genetically modified to
recognize and destroy HIV-infected cells.
The gene-modified cells are then expanded in number
and frozen down in preparation for multiple gene therapy
treatments. As part of the treatments, the modified cells
are re-infused into the patient where they should target
and kill HIV-infected cells.
Many HIV-infected patients are currently being treated
with antiviral drugs which can significantly reduce the
level of HIV in the blood. However, when the drugs are
stopped, the virus typically returns in the blood within a
couple of weeks. The antiviral drugs keep the HIV from
replicating but don't eliminate the reservoirs of
chronically infected cells.
Cell Genesys said it believes its gene therapy could be
complementary to antiviral drugs since the company's
modified cells should target and destroy the reservoirs of
infected cells which harbor the HIV.
Through the new trial, Cell Genesys seeks to determine
whether its gene therapy can reduce the requirement for
long-term treatment with combinations of antiviral drugs.
In related news, the company reported updated results
from its first Phase II AIDS gene therapy trial Sunday at
the Interscience Conference on Antimicrobial Agents
and Chemotherapy Conference in San Diego, Calif.
The company detected preliminary evidence of biologic
activity, including a trend towards decreasing levels of
HIV in gastrointestinal lymphoid tissue - a primary
reservoir of HIV-infected cells - in four of five patient
who underwent biopsies of colorectal tissue following
infusion of genetically modified T cells.
"The results reported at ICAAC in patients with
persistent HIV in the blood set the stage for our second
Phase II trial," said Dale Ando, vice president of
research at Cell Genesys.
The new trial will be conducted at five sites in the U.S.
-Melanie Trottman 201-938-5287
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