Company Updates on Four Phase 2 Clinical Trials Dow AgroSciences CEO Discusses Future Opportunities with Sangamo Technology
NEW YORK, Dec. 5 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that the company will provide an update on milestones achieved in 2007 and preview objectives for 2008 during its annual Investor and Analyst Briefing held in New York City today.
Jerome Peribere, President and CEO of Dow AgroSciences will discuss the success of the two companies' collaboration to develop zinc finger DNA-binding protein (ZFP) technology for use in plant agriculture and Dow AgroSciences' future plans to commercialize the technology. Mr. Peribere will be joined by Edward Lanphier, Sangamo's President and CEO and other members of Sangamo's senior management team.
"We have been very pleased with the progress of our collaboration with Sangamo and by the success that we have had together to confirm our conviction that the ZFP platform has the ability to truly transform the field of plant genetics," commented Mr. Peribere. "We have established that Sangamo's ZFP technology can be used to regulate and modify genes in plants with great specificity and reliability. This enables significant savings in both the rate and cost of development of new crop products with improved traits, characteristics and regulatory designation. We envision that the application of ZFP-mediated gene modification and regulation will become a major component of our plant biotechnology process and, as we enter commercialization and sublicensing, will have a 'game-changing' role in the future of plant breeding."
"The past year has been an exciting and transformational period for Sangamo in which we have successfully achieved several major goals," said Edward Lanphier, president and CEO of Sangamo. "The progress that we have made this year in both clinical and business development activities put us in a very strong position to continue to advance and commercialize our ZFP technology in therapeutics, plant agriculture, laboratory reagents and enhanced cell-lines for pharmaceutical protein manufacturing. We expect 2008 to be another year of significant accomplishments for Sangamo as we achieve a number of major value-creating events."
Mr. Lanphier continued, "We presented positive top-line clinical data from our Phase 1b trial of our lead ZFP Therapeutic(TM), SB-509, an activator of vascular endothelial growth factor (VEGF) for the treatment of diabetic neuropathy (DN). Sangamo is building on this positive data by initiating further clinical trials as we continue our efforts to develop this technology as a novel platform for therapeutic development. This year we also achieved our goal of successfully completing the accrual of subjects to the Phase 2 trial of SB-509 for DN which will give us data in the second half of 2008. In addition to our two Phase 2 clinical trials in DN, we have announced our plans to initiate further Phase 2 studies of SB-509 in stem cell mobilization and amyotrophic lateral sclerosis (ALS) and to initiate two Phase 1 clinical trials in ZFP-mediated gene modification for glioblastoma and HIV/AIDS. We have also advanced and expanded our preclinical pipeline and presented data from several programs at major scientific and medical meetings.
"We also continued to monetize our technology outside of the human therapeutic space. This year we established a major relationship with Sigma-Aldrich Corporation to develop and commercialize ZFP-based laboratory research reagents. We also entered into several cell-line engineering collaborations including a commercial license agreement with Genenetech. The research phase of our collaboration with Dow AgroSciences to apply our ZFP technology for plant agriculture applications is going very well as demonstrated by the achievement of multiple milestones and we look forward to moving into the commercial phase by the fourth quarter of 2008.
"By the second half of 2008, we expect to have data from two Phase 2 trials in patients with diabetic neuropathy, to have initiated two new trials of SB-509 in stem cell mobilization and ALS, and two new Phase 1 trials in patients with HIV infection and glioblastoma. Achievement of these objectives, as well as commercial progress in our collaboration with Sigma and entry into the commercial phase of our collaboration with Dow AgroSciences, will be key to further enhancing the market-leading presence for our technology. As has become increasingly evident, an innovation gap exists 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 ZFP Therapeutic programs."
Sangamo Accomplishments in 2007
During the briefing several of the company's achievements will be
-- Sangamo presented "top-line" clinical data from its ZFP Therapeutic
program to develop SB-509, a ZFP activator of VEGF for the treatment of
diabetic neuropathy at both the Annual Scientific Sessions of the
American Diabetes Association in June and the Society for Neuroscience
Annual Meeting in November. The data showed statistically significant
improvements in several measurements of neurologic health in subjects
with mild to moderate diabetic neuropathy over a six-month period after
treatment with a single administration of SB-509.
-- Sangamo completed accrual for its repeat-dosing Phase 2 trial of SB-509
in patients with mild to moderate DN, and anticipates having data from
this trial in the second half of 2008.
-- Successful prosecution of Sangamo's collaboration with Dow AgroSciences
has resulted in the achievement of several research milestones
including the first demonstration of ZFN-mediated targeted integration
of DNA into a native gene in maize and the first demonstration of
targeting a native gene in canola with ZFNs.
-- Sangamo established a major alliance with Sigma-Aldrich Corporation to
develop and commercialize high value laboratory research reagents based
upon Sangamo's zinc finger DNA binding protein technology. In July
2007, as part of the agreement, Sangamo received an upfront payment of
$13.5 million which included license fees and the purchase of one
million shares of Sangamo stock. Sangamo is also eligible to receive
development and commercial milestone payments of up to $24 million,
sublicense payments and royalties on product sales.
-- Further strengthening its balance sheet, Sangamo completed a registered
direct offering of its common stock. In July 2007, Sangamo sold an
aggregate of 3,278,689 shares of common stock to a group of
institutional investors in a registered direct offering, resulting in
gross proceeds to the company of approximately $30.0 million before
fees and expenses. The company estimates that it will end 2007 with
approximately $80M in cash and cash equivalents.
Select 2008 Objectives
During the briefing Sangamo will also discuss the following anticipated
objectives for 2008:
-- In the second half of 2008, Sangamo expects to have data from its
repeat-dosing Phase 2 trial of SB-509 in patients with mild to moderate
DN and anticipates completing accrual and having data from a second
Phase 2 trial of the same drug in patients with moderate to severe DN.
-- Dow AgroSciences has the option to exercise a commercial license for
the use of our ZFP technology in plant agriculture in the second half
-- The Phase 2 trial that Sangamo plans to initiate in the first quarter
of 2008 evaluating the mobilization of aldehyde bright stem cells in
subjects with diabetic neuropathy after treatment with the SB-509.
-- Plans for a Phase 2 trial of SB-509 for the treatment of ALS will also
be outlined at the briefing. Sangamo expects to initiate this trial in
the first half of 2008.
-- Plans to initiate a Phase 1 trial of a ZFP Therapeutic to treat
glioblastoma in the first half of 2008 and a Phase 1 trial for a ZFP
Therapeutic to treat HIV infection in the second half of 2008.
-- Sangamo expects to report data from the Phase 1 clinical programs in
critical limb ischemia, the severe form of peripheral artery disease in
-- Sangamo estimates that it expects to end 2008 with approximately $55M
in cash and cash equivalents, based on current expense projections and
expected progress in existing corporate relationships.
The presentation from today's Investor and Analyst Briefing will be archived on Sangamo's website until December 20, 2007 and is available at via a link on the Sangamo BioSciences website in the Investor section http://investor.sangamo.com/index.cfm under "Events and Presentations."
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. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on ALS, cancer and HIV/AIDS, 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(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for gene modification. Sangamo has established strategic partnerships with companies outside of the human therapeutic space including Dow AgroSciences, Sigma-Aldrich Corporation and several companies applying 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 research and development of novel ZFP TFs and ZFNs as ZFP Therapeutics, applications of Sangamo's ZFP TF technology platform to specific human disease as well as plant agriculture, high value research reagents and cell-line engineering, eligibility to receive development, milestone and royalty payments from Dow AgroSciences and Sigma-Aldrich Corporation, achievement of research milestones and objectives, strategic partnerships with collaborators, clinical trials of ZFP Therapeutics and anticipated amount of cash and cash equivalents. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties relating to the initiation, completion and outcome of stages of ZFP Therapeutic clinical trials, 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 Quarterly Reports 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.|
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