Sangamo Reports Top-Line Data From Phase II Diabetic Neuropathy Trial
Posted on: Tuesday, 11 November 2008, 09:00 CST
Sangamo BioSciences, a developer of novel DNA-binding proteins for therapeutic gene regulation and modification, has announced top-line data from its SB-509-601 clinical trial, one of Sangamo's three Phase II clinical studies from its ZFP therapeutic program to develop SB-509 for diabetic neuropathy.
The study is a double-blind, placebo-controlled, repeat-dosing multi- center study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs.
Approximately 110 subjects were enrolled into the trial. Subjects were randomized to one of two groups. The larger group was treated by intramuscular injection of 60mg of SB-509 (30mg of SB-509 per leg) into the lower limb every two months. The remaining group received an equal volume of placebo on the same schedule. Each subject received a total of three treatments (day 0, 60 and 120). Subjects received injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.
The data demonstrate that repeat administration of the drug is well tolerated in subjects with mild to moderate diabetic neuropathy (DN). However, no significant differences were observed between the SB-509 and placebo treated subjects in a number of measures of nerve function and health at the primary analysis point, day 180 post-treatment, the company said.
Edward Lanphier, president and CEO of Sangamo, said: "The results from the SB-509-601 study are certainly unexpected. The data that we obtained on measures of nerve health and function are quite different than what we observed in our Phase Ib study. However, the 601 trial is only one part of our broad clinical development program to evaluate SB-509 which we will continue to prosecute.
"Based on our positive Phase Ib clinical data and encouraging interim data from our Phase II repeat-dosing study (SB-509-701A) in subjects with moderate to severe DN, we continue to have a high degree of confidence in this drug."
Source: Datamonitor
Related Articles
- Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
- Multi-Year Clinical Study Data Suggest Use of FDA-Cleared Mobile Air Decontamination Unit, PlasmairT2006 With HEPA-MD(TM), Contributes to Reducing Incidence of Airborne Aspergillosis Infection
- Clinical Trial Data (Phase 2a) Regarding Inhaled Amikacin Will Be Presented at American Thoracic Society International Conference
- Rex Medical Announces the Successful Clinical Retrieval of the Option(TM) Vena Cava Filter in an International Clinical Study
- Noven Presents Pre-Clinical Study Data at AAPS Annual Meeting
- SurModics I-Vation(TM) Intravitreal Implant Six Month Clinical Study Data Presented at the American Society of Retina Specialists Meeting; Well Tolerated, 100% of Patients Maintained or Improved Vision
- SurModics I-Vation(TM) Intravitreal Implant Six Month Clinical Study Data to Be Presented at the American Society of Retina Specialists Meeting
- H. Lee Moffitt Cancer Center and Inovio Biomedical to Unveil Pioneering Clinical Study Data of Plasmid DNA Delivery Using Electroporation
- Coley Pharmaceutical Group Initiates Phase II Clinical Study of Actilon(TM) for Hepatitis C
- Critical Therapeutics Initiates Phase II Clinical Study of CTI-01; Receives CTI-01 U.S. Patent
 |
 |
User Comments (0)
RSS Feeds