RICHMOND, Calif., Dec. 7 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. announced today that the company provided an update on its achieved milestones in 2006 and previewed objectives for 2007 during its annual Investor and Analyst Briefing held in New York this week.
“We are excited about the level of accomplishment in 2006, having successfully achieved major goals, including the initiation of our first Phase 2 clinical trial, advancement and consolidation of our clinical pipeline with the acquisition of all ZFP Therapeutic(TM) angiogenesis assets, progress in our research collaboration with Dow AgroSciences and success in continuing to monetize our technology outside the therapeutic space in multiple cell engineering collaborations,” said Edward Lanphier, president and CEO of Sangamo BioSciences. “These accomplishments are testimony to the quality of our research and development teams and collaborators and the power of our technology platform.”
Mr. Lanphier continued, “I believe that the progress that we have made in 2006 places us in a strong position to advance our business strategy and clinical programs in 2007. By the second half of 2007, we expect to have two ongoing Phase 2 trials in patients with diabetic neuropathy and to be in a position to initiate two Phase 1 trials in patients with HIV infection and glioblastoma. These objectives, as well as additional progress in our collaboration with Dow AgroSciences, will be key to further enhancing a market-leading presence for our technology. As has become increasingly evident, an innovation gap is looming in the pharmaceutical sector, and we believe that our progress in advancing our technology platform, which is unique in its generation of novel highly differentiated therapies and products, will create interest among potential partners for our programs.”
Sangamo Accomplishments in 2006
During the briefing several of the company’s achievements were highlighted including:
* The initiation of Sangamo’s first Phase 2 clinical trial. A repeat-dosing, double blind, multi-endpoint trial was initiated for SB-509, a formulation of a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)) activator of vascular endothelial growth factor (VEGF), in patients with mild to moderate diabetic neuropathy (DN). The study was initiated following encouraging Phase 1 results that showed that the drug was well tolerated at doses that had been shown to be efficacious in animal models and anecdotal improvement of clinical symptoms in patients with DN. Funding of up to $3M from the Juvenile Diabetes Research Foundation will support broad clinical efficacy tests in the Phase 2 trial. * The acquisition of Edwards Lifesciences’ ZFP angiogenesis platform including two clinical programs, a completed Phase 1 study in patients with critical limb ischemia (CLI) and an ongoing Phase 1 trial in intermittent claudication. Sangamo also gained rights to a mature preclinical program targeting ischemic heart disease, as well as potential applications in neurovascular disease, which encompasses a broad range of indications including stroke and spinal cord injury. * Achievement of the first milestones in Sangamo’s research collaboration with Dow AgroSciences to develop its ZFP technology to enable the efficient and reproducible generation of combinations or stacks of multiple new traits in plants. * Sangamo also estimated that it would end 2006 with approximately $53M in cash and cash equivalents, ahead of previous guidance. Select 2007 Objectives
During the briefing Sangamo also discussed the following objectives for 2007:
* By the second half of 2007, Sangamo expects to complete accrual for its repeat-dosing Phase 2 trial of SB-509 in patients with mild to moderate DN, and anticipates initiating and completing accrual for a second Phase 2 trial of the same drug in patients with “blocked nerve” conduction. This second Phase 2 trial, which was unveiled at the briefing, is being initiated based on clinical observations from the Phase 1 study of SB-509 in which improvements in nerve conduction velocity (NCV) were observed in patients with advanced nerve block. These and other data from the Phase 1 DN program will be presented in 2007 at appropriate medical and scientific conferences. * Sangamo also plans to initiate a Phase 1 trial of a ZFP Therapeutic to treat HIV infection in the second half of 2007. The company most recently reported findings from its program to develop a zinc finger DNA-binding protein nuclease (ZFN) for the treatment of HIV/AIDS at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. The data demonstrated that administration of Sangamo’s CCR5-ZFNs enabled the generation of a population of CCR5-modified, T-cells that were permanently resistant to HIV. The company expects to file an IND and initiate clinical testing with collaborator Dr. Carl June, Director of Translational Research at the Abramson Family Cancer Research Institute at the University of Pennsylvania School of Medicine. * Sangamo also discussed for the first time a collaboration to develop ZFNs that can disrupt the glucocorticoid receptor (GR) in T-cells modified to express IL-13 zetakine for the treatment of glioblastoma. Working with their clinical collaborator at the City of Hope National Medical Center Sangamo expects to achieve preclinical proof of concept of GR-modified T-cells in the first half of 2007 and to initiate a Phase 1 trial by late in the second half of 2007. * Sangamo expects to report data from the clinical programs in peripheral artery disease recently acquired from Edwards Lifesciences and expects to detail plans for these programs when the company reports its financial results of the fourth quarter and year-end in February 2007. * Sangamo also gave financial guidance for 2007 estimating that it expects to end 2007 with approximately $35M in cash and cash equivalents, based on current expense projections and expected progress in existing corporate relationships.
The presentation from this week’s Investor and Analyst Briefing will be archived on Sangamo’s website until December 20, 2006 and is available at http://phx.corporate-ir.net/phoenix.zhtml?c=120938&p=irol-IRHome .
About Sangamo BioSciences, Inc.
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 a Phase 2 clinical trial for evaluation of safety in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious 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(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company’s web site at http://www.sangamo.com/.
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-509 and other ZFP Therapeutics in clinical development, the research and development of novel ZFP TFs and ZFNs, clinical trials 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 timing of initiation and completion of clinical trials of SB-509 and other ZFP Therapeutics, whether the results of the Phase 2 clinical trials will validate the safety and efficacy of SB-509, technological challenges, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. See the company’s SEC filings, and in particular, the risk factors described in the company’s Annual Report on Form 10-K and its most recent 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release.
Sangamo BioSciences, Inc.
CONTACT: Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or media, Justin Jacksonof Burns McClellan, Inc., +1-212-213-0006, for Sangamo BioSciences
Web site: http://www.sangamo.com//
