Sangamo BioSciences Provides Update on Company's Accomplishments in 2006 and Objectives for Next 12 Months
Thursday December 7, 7:00 am ET
CEO Edward Lanphier Views 2007 as 'Transformational Year' With Maturing Pipeline, Preeminent IP Position, and Opportunities for Additional Collaborative Partners
RICHMOND, Calif., Dec. 7 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO - News) 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 phx.corporate-ir.net . |
