Press Release

Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601

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Posted 10 November 2008 @ 04:02 pm ET

RICHMOND, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Sangamo BioSciences,Inc. (Nasdaq: SGMO) announced today top-line data from its SB-509-601 clinicaltrial, one of Sangamo's three Phase 2 clinical studies from its ZFPTherapeutic(TM) program to develop SB-509 for diabetic neuropathy (DN). Thedata demonstrate that repeat administration of the drug is well tolerated insubjects with mild to moderate DN. However, no significant differences wereobserved between the SB-509 and placebo treated subjects in a number ofmeasures of nerve function and health at the primary analysis point, day 180post-treatment.

Sangamo management will host a conference call at 5:00 p.m. ET today toreview these data and the ongoing clinical studies supporting the developmentof SB-509.

"Our first Phase 2 study, SB-509-601, had three goals," stated Dale Ando,M.D., Sangamo's vice president, therapeutic development and CMO. "First, wewanted to determine the safety of repeat dosing. Second, we evaluated doseschedule, specifically whether a regimen of three administrations of themaximum dose given at two month intervals would be more effective than asingle administration. Finally, we hoped to gain clarity around clinicalendpoints for use in the design of future studies. While this study has notadded to our data around the most suitable end-points or dosing schedule for aPhase 3 trial, it has demonstrated that the drug continues to have anexcellent safety profile. This is valuable information for our futuredevelopment efforts."

"We also know that SB-509 is an active agent. We have positivepreclinical data in several animal models of angiogenesis and nerve injury. Wealso have impressive data from our prior Phase 1 clinical study, SB-509-401,with a single treatment in the same patient population. In addition, we haveencouraging positive interim data in our SB-509-701A study in which we areassessing recovery of nerve conduction velocity (NCV) in subjects withmoderate to severe DN after two treatments with SB-509. Recovery of NCV inthis more severe population that presents with "blocked" nerves or nerves withunmeasurable NCVs provides a binary outcome. The SB-509-701A trial is nearlycomplete and we expect to have more data from this study in the first quarterof 2009."

"The results from the SB-509-601 study are certainly unexpected," statedEdward Lanphier, Sangamo's president and CEO. "The data that we obtained onmeasures of nerve health and function are quite different than what weobserved in our Phase 1b study. However, the 601 trial is only one part ofour broad clinical development program to evaluate SB-509 which we willcontinue to prosecute. Based on our positive Phase 1b clinical data andencouraging interim data from our Phase 2 repeat-dosing study (SB-509-701A) insubjects with moderate to severe DN, we continue to have a high degree ofconfidence in this drug."

Conference Call

Sangamo will host a conference call today, November 10, 2008 at 5:00 p.m.ET, which will be open to the public. The call will also be webcast live andcan be accessed via a link on the Sangamo BioSciences website in the InvestorRelations section under "Events and Presentations"http://investor.sangamo.com/events.cfm . The webcast replay will also beavailable for two weeks after the call. During the conference call, thecompany will review the data presented today.

The conference call dial-in numbers are 888-690-2875 for domestic callersand 913-981-5543 for international callers. The passcode for the call is2585543. For those unable to listen in at the designated time, a conferencecall replay will be available for one week following the conference call, fromapproximately 8:00 p.m. ET on November 10, 2008 to midnight, Monday November17, 2008. The conference call replay numbers for domestic and internationalcallers are 888-203-1112 and 719-457-0820, respectively. The conference IDnumber for the replay is 2585543.

About SB-509

SB-509 is an injectable formulation of a plasmid encoding a zinc fingerDNA-binding protein transcription factor (ZFP TF(TM)) designed to upregulatethe expression of the gene encoding vascular endothelial growth factor (VEGF-A). VEGF-A has been demonstrated to have direct neurotrophic andneuroprotective properties. In preclinical animal efficacy studies in adiabetic rat model (Diabetes, June 1, 2006; 55(6): 1847-1854), SB-509 hasproven effective in protecting motor and sensory nerve function from disease-induced nerve damage.

Phase 2 Study of SB-509 for Mild to Moderate DN (SB-509-601)

The study is a double-blind, placebo-controlled, repeat-dosing multi-center study designed to evaluate the clinical safety and clinical effects ofrepeat administration of SB-509 in diabetics with mild to moderate diabeticperipheral sensory motor neuropathy in the legs.

110 subjects were enrolled into the trial. Subjects were randomized toone of two groups. The larger group was treated by intramuscular injection of60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every twomonths. The remaining group received an equal volume of placebo on the sameschedule. Each subject received a total of three treatments (Day 0, 60 and120). Subjects received injections in a distribution pattern that targets themajor peripheral nerves in the legs and feet.

The symptoms of diabetic peripheral neuropathy and any changes that occurduring the trial were evaluated based on neurological examination data,electrophysiological testing data, subject neurological questionnaire, andsubject pain assessment. Specifically, investigators used the followingtests: the visual analog scale for pain intensity (VASPI), a modifiedNeuropathy Impairment Score -- Lower Limbs (NIS-LL) scoring system as well astotal neuropathy score (TNS) to assess signs and symptoms of the condition. Inaddition, data from electrophysiological testing using nerve conductionvelocity (NCV) to assess the rate at which a nerve can conduct an electricalsignal, and quantitative sensory testing (QST) with the Vibratron IIinstrument, to assess the threshold of detection of vibration were alsocollected. Skin biopsies were taken to evaluate the direct therapeutic effectof SB-509 on nerve regrowth.

About Diabetic Neuropathy

Diabetic peripheral neuropathy is one of the most frequent complicationsof diabetes. Symptoms include numbness, tingling sensations and painparticularly in the toes or feet. This gradually evolves to loss of sensationand motor function as nerve damage progresses. Ulcers and sores may appear onnumb areas of the foot because pressure or injury goes unnoticed. Despiteadequate treatment, these areas of trauma frequently become infected and thisinfection may spread to the bone, necessitating amputation of the leg or foot.More than 60 percent of non-traumatic lower-limb amputations in the UnitedStates occur among people with diabetes. In 2004, this translated toapproximately 71,000 amputations. Diabetes is a growing problem, the Centersfor Disease Control estimates that from 1980 through 2007, the number ofAmericans with diabetes increased from 5.6 million to 23.6 million and that ofthose about 60 percent to 70 percent have mild to severe forms of neuropathy.

About Sangamo

Sangamo BioSciences, Inc. is focused on the research and development ofnovel DNA-binding proteins for therapeutic gene regulation and modification.The most advanced ZFP Therapeutic(TM) development program is currently inPhase 2 clinical trials for evaluation of safety and clinical effect inpatients with diabetic neuropathy and ALS. Other therapeutic developmentprograms are focused on cancer, HIV/AIDS, neuropathic pain, nerveregeneration, Parkinson's disease and monogenic diseases. Sangamo's corecompetencies enable the engineering of a class of DNA-binding proteins knownas zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs thatrecognize a specific DNA sequence Sangamo has created ZFP transcriptionfactors (ZFP TF(TM)) that can control gene expression and, consequently, cellfunction. Sangamo is also developing sequence-specific ZFP Nucleases(ZFN(TM)) for gene modification. Sangamo has established strategicpartnerships with companies outside of the human therapeutic space includingDow AgroSciences, Sigma-Aldrich Corporation and several companies applying itsZFP Technology to enhance the production of protein pharmaceuticals. For moreinformation about Sangamo, visit the company's web site athttp://www.sangamo.com.

This press release may contain forward-looking statements based onSangamo's current expectations. These forward-looking statements include,without limitation, references to the clinical trials of SB-509, research anddevelopment of novel ZFP TFs and ZFNs and therapeutic applications ofSangamo's ZFP technology platform. Actual results may differ materially fromthese forward-looking statements due to a number of factors, includinguncertainties relating to the initiation and completion of stages of the SB-509 clinical trials, whether the SB-509 clinical trials will validate andsupport tolerability and efficacy of SB-509, technological challenges,Sangamo's ability to develop commercially viable products and technologicaldevelopments by our competitors. See Sangamo's SEC filings, and in particular,the risk factors described in the it's Annual Report on Form 10-K and its mostrecent Quarterly Report on Form 10-Q. Sangamo BioSciences, Inc. assumes noobligation to update the forward-looking information contained in this pressrelease.

SOURCE Sangamo BioSciences, Inc.


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