March 8, 2012
/PRNewswire/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that new data from its program to develop a 'functional cure' for HIV/AIDS were described in two presentations at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), held in
March 5 to March 8
"These data differentiate SB-728-T from other novel therapies as a feasible approach to controlling HIV/AIDS," said
, M.D., Professor of Medicine,
David Geffen School
of Medicine at
and a principal investigator in Sangamo's SB-728-T studies. "The results suggest that SB-728-T has a positive effect on immune health of HIV-infected patients and this effect is persistent for over a year in some subjects. Most importantly, SB-728-T treatment provides HIV-resistant T-cells that are capable of mounting an immune response to an inflammatory event in lymphoid tissues and has yielded encouraging effects on HIV viral load when antiretroviral drugs are withdrawn during a treatment interruption."
"These data add to our understanding of the positive viral load changes in SB-728-T-treated subjects, and suggest that an early cytokine burst may initiate the dramatic and prolonged increase in CD4 counts observed following SB-728-T treatment," said
, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "They also confirm that SB-728-T meets key requirements for our strategy for a 'functional cure' for HIV, by demonstrating durable engraftment and prolonged trafficking and dynamic immunological responsiveness in the gut mucosa. Together, these data further validate our strategy for the continued development of this ZFP Therapeutic as a 'functional cure' for HIV in two ongoing Phase 2 clinical trials designed to extend the observation of a statistically significant correlation between levels of bi-allelic modification of CD4 T cells and viral load reductions during treatment interruptions in HIV infection. The first study builds on the approximate doubling of bi-allelic engraftment that can be achieved in CCR5 delta-32 heterozygotes and seeks to confirm the occurrence of aviremia during treatment interruption as observed in one such patient in our Phase 1 program. The other clinical trial will examine the ability of a lymphopenic preconditioning regimen to enhance bi-allelic engraftment, and reduce viral load during treatment interruption, in non-CCR5-mutated HIV subjects."
Clinical Trial Data Summary
155 "Induction of Acquired CCR5 Deficiency with Zinc Finger Nuclease (ZFN) Modified Autologous CD4 T-cells (SB-728-T) Correlates with Increases in CD4 Count and Effects on Viral Load (VL) in HIV-infected Subjects"
- Thursday, March 8, 2012
21 HIV-infected subjects were enrolled in Phase 1 clinical studies at the
University of Pennsylvania
(SB-728-902) and received a single dose of SB-728-T (5 to 30 billion cells). All subjects were taking highly active antiretroviral therapy (HAART) and had stably controlled undetectable levels of HIV in their blood. Subjects were classified into two groups based on their CD4+ T-cell counts: one group of 15 subjects, with CD4+ T-cell counts below 500 cells/ ul designated Immune Non-Responders (INR), and a second group of six subjects with CD4+ T-cell counts of greater than 450 cells/ ul designated Immune Responders (IR). One month after SB-728-T treatment, six subjects in the INR group enrolled in the
University of Pennsylvania
study underwent a 12-week treatment interruption (TI) of their HAART.
The studies evaluated safety and tolerability, changes in CD4+ T-cell counts and the ratio of CD4+ to CD8+ T-cells as well as persistence of SB-728-T in the blood and trafficking of these ZFN-modified cells into gut-associated lymph tissue. In addition, viral DNA and changes in viral load (VL), as measured by HIV-RNA, were measured during the TI in the six INR subjects.