Sangamo BioSciences, Inc. (SGMO) Special Call October 3, 2011 08:30 ET Executives Dr. Elizabeth Wolffe – Senior Director of Corporate Communications Edward Lanphier – President and Chief Executive Officer Dale Ando – Vice President, Therapeutic Development and Chief Medical Officer Analysts Charles Duncan – JMP Securities Liana Moussatos – Wedbush Chad Messer – Piper Jaffray Presentation Operator
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 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 operation to differ materially from those contained in our projections or forward-looking statements.Now, I’d like to turn the call over to Ed. Edward Lanphier – President and Chief Executive Officer Thank you, Liz and thank you all for joining us for our conference call to discuss the data that we disclosed in a press release this morning from our placebo-controlled double-blind Phase 2b clinical trial SB-509-901 which was designed to evaluate SB-509 in subjects with moderate severity diabetic neuropathy. In summary, SB-509 treatment did not show greater improvements from baseline compared with placebo at a 180 days in key endpoints of sural nerve conduction velocity or NCV, neuropathy impairment score in the lower limb or NIS-LL, quantitative sensory testing or QST, or intraepidermal nerve fiber density or IENFD. We did see trends towards improvement in an exploratory endpoint for lower extremity neurologic sensory exam or LENSE. This is a standardized exam which provides the clinical measure of sensory function in subjects with neuropathy. I have asked Dale to provide more detailed description in the study and findings later in the call. We are obviously disappointed that the SB-509-901 trial did not produce a better outcome in the pre-specified primary and secondary endpoints. We designed the 901 study using clinical data from our previous Phase 1 and Phase 2 clinical trials and believe that we conducted a thoroughly designed and well-controlled trial. Therefore, based upon these results we will discontinue all further clinical development of SB-509.
Moving forward, we will focus our attention and resources on our rich pipeline of ZFP Therapeutic programs, particularly in HIV/AIDS and in monogenic diseases. These are unmet medical needs for which our Zinc Finger Nuclease genome editing technology is uniquely suited to provide a therapeutic solution.Before I say anything more about our future plans, let me turn the call over to Dale to give you some more details on the data that we collected in the 901 trial. Dale? Dale Ando – Vice President, Therapeutic Development and Chief Medical Officer Thanks Edward. The challenge in any clinical development program is to design trials that provide the best chance of seeing a significant difference between the placebo group and the treated group around clinically meaningful and potentially approvable endpoints over the period of the study. As you know, we have previously carried out several Phase 2 trials in population with varying severities of diabetic neuropathy, which is the progressive degeneration of the nerves. Using the data from these studies, we undertook a rigorous accrual process designed to exclude both the very mild and very severe populations and thereby subjects that we believe would be the most responsive to treatment. This selection involved assessing baseline measurements of all major endpoints and accruing only subjects that sell into a pre-specified range. In addition, we instituted rigorous training of site personnel with regard to drug administration and technical and clinical measurements. The trial enrolled 170 subjects in which only three did not complete the trial. So, just from randomized one-to-one and treated by intramuscular injections at day 0, 60, and 120 with either SB-509 or a saline placebo. We monitored the progression of the diabetic neuropathy symptoms by measuring sural, NCV, NIS-LL, QST, and IENFD and LENSE at baseline in several points throughout the 100 days study period. We also assess the quality of life using questionnaires and monitored their underlying diabetes. Read the rest of this transcript for free on seekingalpha.com