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Friday, January 13, 2012

HIV Vaccine Advances to Stage Two Human Clinical Trials

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Scientists were shocked to discover the cure for HIV was simply an overwhelming dose of microscopic AIDS ribbons. OK, not really. Still, great news!

The various HIV “cures” and vaccines in development continue to speed ahead, with one pharmaceutical company’s product advancing into stage 2 human clinical trials.

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today the initiation of two new Phase 2 clinical studies (SB-728-1101 and SB-728-902, Cohort 5) in its program to develop a “functional cure” for HIV/AIDS. Sangamo’s ZFP Therapeutic® approach (SB-728-T) generates T-cells that are resistant to HIV infection using its zinc finger nuclease (ZFN) technology to permanently disrupt the DNA sequence encoding CCR5, a co-receptor used by HIV to enter cells. The company expects to present data from its SB-728-T HIV clinical trials at appropriate medical meetings in 2012.

“We are delighted to be able to open these two important clinical studies ahead of schedule,” said Geoff Nichol, M.B. Ch.B., Sangamo’s executive vice president, research and development. “Data from earlier Phase 1 trials demonstrated a statistically significant relationship between the number of circulating T-cells in which both CCR5 genes are modified and the reduction in HIV viral load in infected subjects during an interruption of anti-retroviral therapy. Both of these new Phase 2 clinical trials are specifically designed to confirm and further investigate these findings.”

The new studies employ two approaches to increase the number of engrafted T-cells in which both CCR5 gene copies are modified (biallelically modified) in SB-728-T-treated, HIV-infected subjects. The first, an extension of an ongoing trial (SB-728-902, Cohort 5), is designed to further investigate the effect of SB-728-T treatment on HIV viral load in subjects that are naturally heterozygous for the CCR5 delta-32 gene mutation (i.e. one of their two CCR5 gene copies has the mutation and one is normal).

 The second study (SB-728-1101), in HIV-infected subjects without the CCR5 delta-32 mutation, employs a conditioning pretreatment designed to significantly enhance the number of engrafted biallelically modified T-cells.
The Sangamo vaccine is one of several products racing neck and neck toward mass market approval and release. It’s safe to say that if the first “cure” to hit the market is produced by the American pharmaceutical industry, it will be a costly product that creates enormous corporate wealth.

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