Therapeutic Areas
Therapeutic Areas: Endocrinology | Neurology
Disease Category: Diabetic Neuropathy

Trial Information

A Phase I/II Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Patients with Painful Diabetic Peripheral Neuropathy.

A phase I/II, open label, dose-escalation, multicenter, 12-month study designed to assess the safety and tolerability of unilateral intramuscular injection in the calf of VM202 in patients with painful diabetic peripheral neuropathy (DPN).

Screening will involve the following procedures: medical history, physical exam, medication review, questionnaire, assessment of neuropathy, cancer screening, retinal fundoscopy; urine and tests including a viral screen; photograph and measurement of ulcer, pregnancy test (if you are a female), and 12 lead EKG.

Each subject is then treated with study drug twice, with 14 days between injections. Study drug will be injected into the calf muscle using a syringe with a fine needle (27 gauge).

After the injection visits, subjects will be followed for the course of one year, involving 6 more visits to the clinic. At these visits, the following tests or evaluations will be done: medication review, questionnaires, vital signs, blood tests including HGF and study drug, photograph and measurement of any ulcers which were present before the first injection, injection site reaction assessment, and assessment of side effects.

Patient Inclusion Criteria:

• Age ≥ 18 years to ≤ 75 years
• Glycosylated hemoglobin A1C of ≤ 10%
• Painful DPN diagnosed in both lower extremities
• Stable treatment for last 3 months
• No anticipated changes in medication
• No new symptoms associated with diabetes
• Lower extremity pain for at least 6 months
• Negative pregnancy test, if female

Patient Exclusion Criteria:

• Neuropathy caused by other condition
• Pain more severe than neuropathic pain
• Progressive or degenerative neurological disorder
• Myopathy
• Inflammatory disorder of the blood vessels (Buerger's disease)
• Active infection
• Chronic inflammatory disease (Crohn's, Rheumatoid Arthritis)
• HIV, HTLV, Hepatitis B or C, or known immunosuppression
• Chronic treatment with immunosuppressive drugs
• Chemotherapy or radiation therapy
• Stroke or myocardial infarction within last 6 months
• Ophthalmologic conditions pertinent to proliferative retinopathy
• Cataract surgery within last 6 months
• Vascular lesions of the posterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma)
• Macular edema
• Photocoagulation
• Sickle cell retinopathy
• Ischemic retinopathy (due to retinal venous statis or carotid artery disease)
• Choroidal angiogenesis
• Large elevated choroidal nevi, melanomas, or choroidal vascular tumors (choroidal hemangioma)
• Hemoglobin <9 g/dL
• White Blood Cell (WBC) count <3,000 cells per microliter
• Platelet count <75,000/mm3
• Creatinine >2 mg/dL
• Glomerular Filtration Rate (GFR) <50 - Kidney function
• Aspartate aminotransferase (AST) and/or alkaline phosphatase (ALP) (if > 2x the upper limit of normal)
• Use pf gamma-linolenic acid (GLA), alpha-lipoic acid (or any other high dose dietary antioxidant supplement)
• Uncontrolled hypertension (>200mmHg/110 mmHg)
• New malignant neoplasm (except basal or squamous cell carcinoma if excised and no evidence of recurrence)
• Malignant tumors or abnormal screening test suspicious for cancer
• Family history of colon cancer in any first degree relative (unless they have undergone a colonoscopy in the last 12 months with negative findings)
• Elevated PSA unless prostate cancer has been excluded
• Subjects requiring >81 mg daily of acetylsalicylic acid (Aspirin)
• Major psychiatric disorder in past 6 months
• History of drug or alcohol abuse/dependence in the past 2 years
• History of tobacco abuse within past 5 years
• BMI >38 kg/m2
• Use of an investigational drug or treatment in the past 12 months

Emily Kunka, CCRP, Research Study Programs Coordinator 2
Northwestern University
Neuromuscular Disorders Program
Tarry Research and Education Center, 13-727
300 E. Superior Street
Chicago, IL 60611
Phone: 312-503-0160
Fax: 312-908-0865
EMail: nwu-eck116@northwestern.edu

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