RICHMOND, Calif., Sept. 15 Sangamo BioSciences,Inc. (Nasdaq: SGMO) announced today the presentation of positive interim Phase2 clinical data from its ZFP Therapeutic(TM) program (SB-509-701) at theInternational Society for Cellular Therapy (ISCT) Europe Regional Meeting inAntwerp, Belgium. The data presented demonstrate an improvement in nerveconduction velocity (NCV) in SB-509 treated subjects with moderate to severediabetic neuropathy (DN), a patient population that until now has beenconsidered impossible to treat.
Sangamo management will host a conference call at 11:00 a.m. ET today todiscuss these data.
In addition, on September 8, 2008, new data were presented from Sangamo'sPhase 1b study (SB-509-401) at the 44th Annual Meeting of the EuropeanAssociation for the Study of Diabetes (EASD) demonstrating a statisticallysignificant (p= 0.0016) positive correlation of 2 or more response endpointsin the SB-509 treated group compared with placebo treated subjects at day 180post-treatment. Response endpoints were defined as greater than a 14%improvement in quantitative sensory testing (QST), greater than 0.8meters/second (m/sec) improvement in NCV and greater than a 3 pointimprovement as judged by the Neuropathy Impairment Scale -- Lower Limbs(NIS-LL). Data have previously been presented from this trial demonstrating astatistically significant improvement in NIS-LL and QST and trends forimprovement in NCV. Sangamo has a larger, repeat-dosing clinical trial(SB-509-601) in this population of subjects with mild to moderate DN.
Data presented today at ISCT from the study SB-509-701 were collected fromsubjects with moderate to severe diabetic peripheral neuropathy. All subjectsentered the trial with between one and six nerves in the lower limb that were"blocked" or for which no NCV could be measured. The majority of the subjectshad at least one blocked sural nerve, the most relevant in DN. Subjectsreceived two treatments in both legs of either placebo (n=10 subjects) orSB-509 (n=17) (60 mg total dose, 30 mg per leg) one at Day 0 and one at Day90. Recovery of NCV during 180 days post treatment in subjects who entered thetrial with blocked sural nerves was observed in 75% of the SB-509-treatedsubjects compared to 25% of the placebo-treated group. SB-509 was welltolerated and no drug-related severe adverse events were observed.
"While these are interim data, we are very pleased and excited by thereturn of NCV in such a high percentage of these subjects," commented DaleAndo, M.D., Sangamo's vice president, therapeutic development and CMO. "Thisis a patient population for which historically there have been absolutely notreatment options. This sural nerve recovery data in subjects in the Phase 2study reinforces our preliminary and surprising data in 3 subjects in thePhase 1 trial.
The sural nerve on the foot is a sensory nerve and one of the first nervesto be affected as diabetic neuropathy progresses. However, some of thesubjects enrolled in this study had quite severe neuropathy with all sixnerves of the nerves that we are monitoring blocked. Not surprisingly, wefound that subjects entering the study with fewer blocked nerves showed thehighest rates of response to these two treatments with SB-509.
When we began this trial we chose a more conservative two dose regimen asthis is a sicker population than that originally tested in the Phase 1b study.The data suggest that two doses are well tolerated and that our observationsfrom the Phase 1 trial were worth pursuing. We have expanded the trial toinclude a third treatment with SB-509 and believe that the increased dose andincreased subject numbers will provide us with valuable information indetermining how well more severely affected DN patients will respond."
A total of 45 subjects have been enrolled in the trial (SB-509-701) whowere randomized to one of two groups in a 2:1 ra