Sangamo BioSciences, Inc., (SGMO)
Q1 2011 Earnings Call
April 26, 2011 5:00 pm ET
Edward Lanphier – President, Chief Executive Officer
H. Ward Wolff – Executive Vice President and Chief Financial Officer
Dale Ando – Chief Medical Officer and Vice President, Therapeutic Development
Elizabeth Wolffe – Senior Director of Corporate Communications
Charles Duncan – JMP Securities
Joseph Schwartz – Leerink
Liana Moussatos – Wedbush Securities
Good afternoon and welcome to the Sangamo BioSciences Teleconference to discuss First Quarter 2011 Financial Results. This call is being recorded.
I will now pass you over to the coordinator of this event, Dr. Elizabeth Wolffe, Senior Director of Corporate Communications.
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Following this introduction, Edward will highlight recent activities, Ward will then briefly review first quarter financial results for 2011. And finally, Dale and Edward will update you on our ZFP Therapeutic programs and our goals for 2011. Following that, we'll open up the call for questions.
As we begin, I’d like to remind everyone that the projections and forward-looking statements that we discuss during this conference call are based upon the information that we currently have available. This information will likely change over time. By discussing our current perception of the market and the future performance of Sangamo with you today, we are not undertaking an obligation to provide updates in the future.
Actual results may differ substantially from what we discuss today and no one should assume at a later date that our comments from today are still valid. We alert you to be aware of risks that are detailed in the documents that the company files with the Securities and Exchange Commission, specifically our quarterly reports on Form 10-Q and our Annual Report on Form 10-K.
These documents include important factors that could cause the actual results of the company’s operations to differ materially from those contained in our projections or forward-looking statements.
Now, I’d like to turn the call over to Edward.
Thank you, Liz. And thank you all for joining us for our conference call to discuss our first quarter results for 2011. Let me begin by briefly recapping the events of the past few months. We continued to make important progress in our ZFP Therapeutic clinical programs.
In January, we announced the completion of accrual of our Phase 2b clinical trial of SB-509 in subjects with moderate severity diabetic neuropathy. This double-blind, repeat-dosing, placebo-controlled, study SB-509-901 is designed to finalize dose, treatment schedule and primary and secondary approvable endpoints for future pivotal trials.
We accrued 170 subjects, slightly more than the initial objective of 150 and are on track to present top line efficacy data from this study in the second half of this year. As we have said before, with positive data from this trial, we intend to move forward with partnering discussions to efficiently move this first-in-class disease modifying drug to the market.
I look forward to updating you on the upcoming, on the outcome of this trial later this year. We've also presented very positive preliminary clinical data from our studies of our ZFP Therapeutic for HIV/AIDS at one of the most important scientific meetings for the HIV field, the Conference on Retroviruses and Opportunistic Infections or CROI.
We are evaluating SB-728-T, an autologous CD4 T-cell product in which the CCR5 gene is modified by our zinc finger nucleases in two Phase 1 studies. Data were presented from both Sangamo's dose escalation trial SB-728-T-902 as well as the single dose study of the drug, it is ongoing at the University of Pennsylvania.
Importantly, we observed that the infusion of the modified cells was fate and well tolerated. The sales were persistent and traffic normally and the treatment had positive effects on the subject’s immune system. These data give us tremendous confidence and the potential for this approach going forward as we complete these studies and prosecute our new Phase 1/2 study in HIV subjects that are not currently on anti-retroviral therapy and thus have active viral infections.
I’ll ask Dale to discuss the clinical data that we presented at CROI in more detail later in the call. In addition to the presentations of the clinical data at CROI, our collaborator Dr. Paula Cannon presented positive preclinical data from our studies that used the same CCR5 ZFNs in CD34 hematopoietic stem cells. The data demonstrated the ZFNs can be used to make stem cells resistant to HIV infection without affecting their ability to differentiate into all of the cells of the immune system.
Furthermore, in a mouse model of the HIV infection these ZFN modified cells that lack the functional CCR5 receptor have a selective advantage over the non-modified cells gradually taking over the entire population of the immune system cells and within the space of several weeks eliminating the virus.
This work is being carried out as part of the collaboration with Carl and scientist’s at City of Hope that is funded by CIRM or the California Institute for Regenerative Medicine. With the ultimate goal of advancing this program to an IND. In the summary, the four oral presentation, oral presentations of Sangamo’s programs at CROI provided a strong proof of concept for our clinical approach and showcase the full range of our programs in HIV/AIDS. If you have not done so already, I will encourage you to view the webcast and listen to the presentation which can be accessed via the CROI website.