Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Inclusion Criteria: * Capable of understanding the purpose and risks of the study and sign a statement of informed consent * Male 50-80 years of age * Presence of LUTS (lower urinary tract symptoms) for at least 3 months * Prostate volume measured by TRUS (transrectal ultrasound) \> 30 cc * Qmax \< 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided) * I-PSS (International prostate symptom score) \> 12 * PSA \> 1.0 ng/mL * Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential * Able to comply with the prescribed treatment protocol and evaluations Exclusion Criteria: * Prior treatment for BPH with alpha-blockers and/or herbal supplements in the past 2 weeks (alpha-blockers and herbal supplements for the treatment of BPH are not allowed during the study). Prior treatment with 5-alpha-reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment. * Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.) * Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (for subjects with PSA between 4 - 10 ng/mL, prostate cancer must be ruled out to the satisfaction of the Principal Investigator. Subjects with PSA \>10 ng/mL are excluded.) * Active urinary tract infections (UTI) * Active cardiac, renal or hepatic disease as evidenced by: 1. Serum creatinine \> 1.8 mg/dL 2. ALT or AST \> 2.5x the upper limit of normal at screen 3. History of active myocardial infarction,unstable cardiac arrhythmias or stroke within 6 months prior to screening 4. Uncontrolled congestive heart failure * Uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dL) * Use of systemic teriods for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed. * Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening * Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the investigator,pose an unnaceptabele risk to the subject