Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance
Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance
Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate
 cancer who are otherwise healthy and free of significant co-morbidities and have chosen
 active surveillance for disease management. The investigators will assess how OMN54 affects
 PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will
 be tested to follow disease evolution.
Inclusion Criteria:

 - Localized prostate cancer suitable for active surveillance

 1. Histologically confirmed adenocarcinoma of the prostate, with Gleason Score 6 or less
 prostate cancer. No limit in the percentage of cancer in each core or percentage of
 positive cores.

 2. Male, 18 years or older

 3. Able to swallow the soft gelatin capsule form of the drug which is ~6mm long.

 4. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.

 5. No previous treatment for prostate cancer (including hormonal therapy, radiation
 therapy, surgery, or chemotherapy).

 6. ECOG Performance Status 0 or 1.

 7. Patient has elected Active Surveillance as preferred management plan for prostate
 cancer.

 8. Written informed consent obtained prior to any patient participation.

 9. Participant is accessible and compliant for follow-up.

 10. Prostate biopsy requirements:

 1. If diagnosis was within one year of baseline visit, participant must have at
 least one biopsy with at least 10 cores.

 2. If diagnosis was more than 1 year prior to baseline visit, participant must have
 a minimum of 2 biopsies, one of which must be within 2 years prior to baseline
 visit.

 11. Voiding requirements: IPSS score of at least 15 and Qmax < 15 cc/s.

 12. Adequate hematopoietic function as demonstrated by:

 -  hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions

 -  Platelet count ≥100,000 platelet/mm3 (100 x 109/L)

 -  White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC)
 ≥1.5 x109/L

 13. Adequate hepatobiliary function as demonstrated by:

 -  Total bilirubin level within normal limits

 -  Alanine aminotransferase (ALT) levels within normal limits

 -  Adequate renal function as demonstrated by creatinine level within normal limits
 or creatinine clearance within normal limits

 -  Coagulation profile (PT, PTT, INR and TCT) within normal limits

 14. If of reproductive capacity, willing to use an effective double barrier method of
 birth control (i.e., latex condom, partner use of diaphragm, cervical cap, etc) during
 the study and for 30 days after the last administration of OMN54

 Exclusion Criteria:

 1. Unwillingness or inability to undergo serial prostate biopsy or MRI.

 2. History of other malignancies, except: adequately treated non-melanoma skin cancer or
 adequately treated superficial bladder cancer (Ta) or other solid tumors curatively
 treated with no evidence of disease for > 5 years.

 3. Previous surgical intervention for BPH

 4. Active uncontrolled infection, including known history of HIV, hepatitis B or C

 5. Concurrent uncontrolled hypertension

 6. Congestive Heart Failure

 7. Hepatic disease (cirrhosis, hepatitis, hepatocellular carcinoma or liver failure of
 unknown etiology)

 8. Renal disease (glomerulonephritis, nephropathy, polycystic kidney disease)

 9. Patients requiring new treatment of BPH (either medical or surgical) are not eligible.

 10. Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory
 bowel disease), or significant bowel resection that would preclude adequate
 absorption.

 11. Known hypersensitivity to any of the three botanical constituents of Aneustat™
 (OMN54); soy; any of the plants belonging to the Ganodermataceae family, e.g., reishi
 mushroom (Ganoderma lucidum, lingzhi); any plants belonging to Labiatae or Lamiaceae
 families, e.g., culinary herbs including basil, mint, rosemary, sage, savory,
 marjoram, oregano, thyme, lavender, and perilla; or Aneustat™ (OMN54) excipients.

 12. Concurrent administration, or exposure within 30 days, of:

 -  Investigational drugs and devices

 -  Chemotherapy

 -  Radiation therapy

 -  Immunotherapy