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Purpose of the Study
About SB-509
Disclosure of Risks
Study Procedure and Time Commitment
Participating Centers: Contact Information
Trial Enrollment Criteria
To Learn More
Phase 2 Clinical Trial
Sangamo is currently recruiting patients for a Phase 2 clinical trial in diabetic neuropathy. A Phase 2 trial is used to test an experimental drug in a larger group of people to determine efficacy and to further evaluate the drug's safety, or to identify side effects. In this study, the effects of repeat treatment will also be assessed.

    Protocol:    SB-509-0601
    Trial Name:    A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects with Diabetic Neuropathy


Purpose of the Study

    Primary Objectives:

    • To compare in subjects with diabetic neuropathy the effect of SB-509 versus placebo on a pre-defined multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total neuropathy score (TNS), nerve conduction velocity (NCV), quantitative sensory testing (QST), and epidermal nerve fiber density (ENFD) and regeneration (ENFDR).

    Secondary Objective:

    • To evaluate the safety of SB-509 as compared to placebo in subjects with diabetic neuropathy.



About SB-509:
 SB-509 contains the gene, or DNA code, to specify a protein. When SB-509 is injected into the leg, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes the cells to increase the production of another protein called Vascular Endothelial Growth Factor (VEGF), which may improve the structure and function of nerves. This increase in VEGF may protect and repair the damage caused to nerves by diabetic neuropathy.

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Disclosure of Risks
 Please note that the safety and effectiveness of this product has not yet been fully established. As with other investigational drugs in clinical trials, this investigational product may not benefit you and may cause side effects. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later and may be severe. You should discuss these risks with your physician or a study doctor.

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 Study Procedure and Time Commitment:
 Subjects will undergo tests to determine their eligibility for the study. At the start of the study patients will randomized and will be given either placebo or SB-509 in both lower limbs by intramuscular injection. SB-509 and placebo will be administered by multiple intramuscular injections on three separate occasions at day 0 day 60 and day 120. You, your doctor, and the hospital will be blinded to treatment, which means that you will not know whether you received the study drug or the placebo, until after the study is completed.

Subjects will be evaluated for 7 months after the last dose, with visits at Days 0,14, 30, 60, 74, 90, 120, 134, 150, 151,180, 210, 240, 270 and 360.

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Location of Participating Centers
Study Centers currently enrolling subjects are located in the following States:
  • California
    • Diablo Clinical Research
      2255 Ygnacio Valley Road, Suite M
      Walnut Creek, CA
      *Contact:
      Bonnie Smith
      ph: (925) 930-7267
      •

    • Coordinated Clinical Research
      La Jolla, CA 92037
      *Contacts:
      Luci Barbi
      ph: (858) 455-5463
      Jessica Andrews
      ph: (858) 455-5463
      cns@cns.cts.com


  • Florida
    • Bradenton Research Center
      Bradenton, Florida, 34205
      *Contact:
      Carolyn McElveen
      ph: (941) 708-0005
      cebmce@hotmail.com


    • Neurology Clinical Research
      Sunrise, Florida, 33351
      *Contact:
      Pilar Hernandez, MD, CRC
      ph: (954) 475-8171 Ext. 145
      phernandez@neuroresearch.net


  • Nebraska


  • Texas
    • Diabetes and Glandular Disease
      Research Associates
      5107 Medical Dr.
      San Antonio, TX 7822-4801
      *Contact:
      Warren Douglas
      ph: (210) 615-5565
      •

    • Nerve and Muscle Center of Texas
      6624 Fannin Street, Suite 1670
      Houston, Texas
      *Contact:
      Ayser Al-Kazzas
      ph: (713) 795-0033 ext. 27
      •


(We expect to add additional clinical trial sites to this list as the SB-509-0601 diabetic neuropathy study is expanded)

If you are interested in participating in this study, please show this information to your primary care physician to see if it is appropriate for you prior to contacting our clinical sites. Your physician is in the best position to help you make decisions about participating in clinical research trials.

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 Trial Enrollment Criteria
 To be eligible for this study, subjects should:
  • have a clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months prior to the study.
  • have received a diagnosis of mild to moderate sensori-motor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
  • be an adult male or female between the ages of 18 and 65.
  • be willing to participate in the study as an outpatient and make the required visits to the study center during the treatment and after the treatment periods, meet and follow the study requirements.
  • have abnormal signs of sensori-motor diabetic neuropathy based on a rating scale that is based on questions, a physical exam and nerve conduction studies called the TNS 40-point scale scoring system, with a total score of greater or equal to 4 from a minimum of two separate categories.
  • have abnormal results on specialized nerve testing in the legs. The study doctor or study staff will do this specialized nerve testing with a Nerve Conduction Test and Quantitative Sensory Testing, both of which you will read about below.
  • have measurable sural nerve responses in both legs.
  • have an HgbA1C level that is 9% or lower, with stable blood sugar control for at least 3 months. The study doctor will check this.
  • have an eye exam by an eye doctor to rule out the presence of abnormal growth of blood vessels or proliferative diabetic retinopathy (eye complications of diabetes).
  • have had up-to-date screening tests for cancer as recommended by the American Cancer Society. These tests include a PSA blood test for prostate cancer (for males over age 45), a pap smear for cervical cancer (for females), a mammogram (for females over age 40), and a flexible sigmoidoscopy for colon cancer (if over age 50). To be in this study, you must have written proof of normal test results within the last 12 months. If these screening tests show you have cancer, you will not be able to be in the study.
  • have a normal chest X-ray without evidence of heart enlargement or congestive heart failure.
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Exclusion Criteria
Subjects with the following are NOT eligible to participate in this study:
  • have moderate to severe ischemic heart disease, any history of congestive heart failure or have had a myocardial infarction (heart attack) within the previous 6 months.
  • have chronic foot or leg ulcers for >1 month, gangrene in the lower extremity, or any previous amputation of the lower extremity.
  • have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than < 0.75.
  • have a history of cancer within the past 10 years (except curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
  • be participating in another research study while you are in this study or within 30 days of receiving the study drug.
  • have colon polyps. If you have history of benign colonic polyps that have been removed, you must have evidence of a normal colonoscopy within the last 12 months.
  • have an active infection requiring antibiotics that you take by swallowing or is administered directly into a vein. If you had an infection in the past, you must not be receiving treatment for that infection within 2 weeks of receiving the study drug.
  • have abnormal kidney function.
  • require any drug that depresses your immune system (such as methotrexate, cyclophosphamide, or cyclosporine) when you receive the study drug and for 30 days afterwards.
  • have a known disorder that affects your immune system (such as HIV/AIDS, HBV, HCV, sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
  • have any other condition that, in the opinion of the study doctor, might cause problems during the study (for example, affect your health or study test results).
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To Learn More
To find out more about current clinical trials that may be right for you, go to www.clinicaltrials.gov.

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