Sangamo BioSciences Provides Update On Phase 1 Safety Trial Of SB-728-T For HIV/AIDS

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Nov 2009 - 2:00 PST

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Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that data from the University of Pennsylvania investigator sponsored Phase 1 safety study of Sangamo's zinc finger nuclease (ZFN) based product, SB-728-T, for HIV/AIDS were inadvertently and prematurely disclosed on the internet.

Data were presented in a student course at the University of Pennsylvania School of Medicine from a single subject treated with SB-728-T who, as part of the study, began a structured treatment interruption (STI) from his antiviral drug therapy four weeks after SB-728-T treatment. This subject was reported to have stable CD4+ and ZFN-modified T-cell levels and an undetectable viral load one month post STI initiation. Previous studies have shown that in subjects undergoing an STI, the average time to detection of an increase in viral load is two to four weeks. While this subject continues to demonstrate stable CD4+ T-cell counts and stable levels of ZFN-modified T-cells, by six weeks post STI initiation the subject had a detectable viral load.

As previously stated, the company and the University of Pennsylvania intend to provide updates on the two ongoing Phase 1 SB-728-T trials only at appropriate scientific or medical meetings.

About Sangamo

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy and ALS. Sangamo also has two Phase 1 clinical trials to evaluate safety and clinical effect of a ZFP Therapeutic for the treatment of HIV/AIDS. Other therapeutic development programs are focused on cancer, neuropathic pain, nerve regeneration, Parkinson's disease and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN) for gene modification. Sangamo has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences, Sigma-Aldrich Corporation.

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the clinical trials of SB-728-T, research and development of novel ZFP TFs and ZFNs and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the completion of stages of the SB-728-T clinical trials, whether the SB-728-T clinical trials will validate and support tolerability and efficacy of SB-728-T, technological challenges, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See Sangamo's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking information contained in this press release.

Source: Sangamo BioSciences, Inc