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1 Clinical Trial Details (PDF Generation Date :- Wed, 12 Sep :03:27 GMT) CTRI Number Last Modified On 14/02/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 22/05/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A clinical trial to study the safety and efficacy of S-equol in the treatment of Benign Prostate Hyperplasia. Randomized, Double-Blind, Multicenter, Placebo-Controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of 4-Weeks Treatment with AUS-131 (S-Equol) on Benign Prostatic Hyperplasia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) AUS-CT04 Amendment #4, Version 2.5, dated 13 Apr 2012 F.No.CT/124/11-DCG (I) NCT Designation Affiliation Phone Fax Designation Affiliation Phone Fax Designation Affiliation Protocol Number DCGI ClinicalTrials.gov Details of Principal Investigator Ms Sushma Srikanth Clinical Operations Manager Novotech Clinical Research private limited Novotech Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road, Sushma.Srikanth@novotech-cro.com direct: mobile: Sushma.Srikanth@novotech-cro.com Details Contact Person (Scientific Query) Ms Sushma Srikanth Clinical Operations Manager Novotech Clinical Research private limited Novotech Clinical Research private limited Unit #1103, 11th Floor, Prestige Meridian-1, #29, M.G. Road, , Phone: Fax: Sushma.Srikanth@novotech-cro.com Details Contact Person (Public Query) Ms Sushma Srikanth Clinical Operations Manager Novotech Clinical Research private limited Novotech Clinical Research private limited Unit #1103, 11th Floor, page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Prestige Meridian-1, #29, M.G. Road, , Phone: Fax: Source of Monetary or Material Support > Novotech Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road, Type of Sponsor NIL List of Countries Australia United States of America of Principal Investigator Dr Shams Abdul Kadar Iqbal Dr Ajit Saxena DrHKNagaraju Dr Sujata Patwardhan Primary Sponsor Details 1776 Mentor Ave, Suite 340 Cincinnati, OH USA (fax) Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Inamdar Multispeciality Hospital, Indraprastha Apollo Hospitals M S Ramaiah Memorial Hospital Seth G S Medical College and KEM Hospital Inamdar Multispeciality Hospital, Hospital Building S. No, 15, Fatima Nagar, Pune Pune MAHARASHTRA Indraprastha Apollo Hospitals, Sarita Vihar, Delhi-Mathura Road New Delhi , South DELHI M S Ramaiah Memorial Hospital New BEL Road, MSRIT Post, , drshamsi@hotmail.com ajitsaxena@hotmail.co m nagarajharohally@hotm ail.com Department of Urology, th Floor, New Building, Seth G S Medical sujata.patwardhan@red College and KEM iffmail.com Hospital, Acharya Donde Marg, Parel, Mumbai Mumbai page 2 / 7

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent MAHARASHTRA Dr Sher Singh Yadav SMS Hospital Department of Urology, SMS Hospital, JLN Marg, Jaipur , Rajasthan. Jaipur RAJASTHAN dryadavsms@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethical Review Board,M.S. Ramaiah Medical College & Hospitals, MSR Nagar New BEL Road, MSRIT Post, Approved 30/12/2011 No Ethics committee for research on Human Subjects,G. S. Medical Colllege and KEM Hospital, Parel, Mumbai Approved 27/01/2012 No Ethics committee of SMS Medical college and attached Hospitals,SMS Medical Hospital, JLN Marg, Jaipur Ethics Committee on Clinical Trials,Indraprastha Apollo Hospitals, Sarita Vihar, Delhi Ethics Committee-Inamdar Multispeciality Hospital,Inamdar Multispecialty Hospital, Pune Status Approved 31/10/2011 No Approved 08/11/2011 No Approved 21/09/2011 No Date Approved/Obtained 13/04/2012 Health Type Patients Condition Benign Prostatic Hyperplasia Type Details Intervention AUS-131 (S-equol) capsules 10 mg BID (20 mg total daily dose)for oral administration for 4 Weeks Comparator Agent AUS-CT-04 is a Placebo-Contro lled,non-comparative, Proof-of-Concept Trial S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-? agonist that (Ausio) is developing for the treatment of BPH in men. Patients in all treatment groups, including placebo, may leave the study for any reason, including for reasons of adverse events. Such patients will be referred to their physician, and page 3 / 7

4 Inclusion Criteria Exclusion Criteria Intervention AUS-131 (S-equol) capsules 50 mg BID (100 mg total daily dose)for oral administration for 4 Week Intervention Age From Age To Gender Details Details AUS-131 (S-equol) capsules 150 mg BID (300 mg total daily dose)for oral administration for 4 Weeks Year(s) Year(s) Male Inclusion Criteria provided medical advice from the Principal Investigator, regarding what medical treatment (rescue strategy) would be appropriate for their condition. S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-? agonist that (Ausio) is developing for the treatment of BPH in men. S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-? agonist that (Ausio) is developing for the treatment of BPH in men. Inclusion Criteria A patient will be eligible for study entry if all of the following inclusion criteria are met: 1. Is male > 50 and?70 years of age at Screening. 2. Has a normal digital rectal exam with the exception of prostate enlargement. 3. Has suffered from symptoms of BPH for at least the 6 months before Screening (e.g., micturition disturbances such as daytime frequency, nocturia, urgency, difficulty initiating micturition, impaired quality of the urinary stream, feeling of incomplete voiding, or interruption of the urinary stream). 4. Has a prostate volume? 20 ml and? 70 ml as assessed by ultrasound. 5. Has a serum PSA concentration > 1.5 ng/ml and? 10 ng/ml at Screening. 6. Has an IPSS? 13 at Screening and Baseline. 7. Has a Qmax > 5 cc/sec and 8. Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements. 9. Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the conduct of any study procedure. 10. Is willing and able to comply with all study requirements and instructions of the site study staff. Exclusion Criteria Exclusion Criteria A patient will not be eligible for study entry if any of the following exclusion criteria are met: 1. Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug. 2. Neurogenic bladder dysfunction. 3. Has bladder neck contracture or urethral stricture. 4. Has acute or chronic prostatitis or urinary tract infection. page 4 / 7

5 5. Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10 ng/ml; patients with a PSA concentration > 4 ng/ml and? 10 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator. 6. Has a residual void volume > 250 ml. 7. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, renal, endocrine, or gastric disease or any other condition that, in the opinion of the investigator, could compromise the patient s welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. 8. Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma). 9. Has a history of smoking more than 5 cigarettes daily within the year before Screening. 10. Has resting systolic blood pressure (BP) > 160 mmhg or BP > 90 mmhg or 11. Has bladder stones as detected by ultrasound. 12. Has hematuria of unknown etiology. 13. Had previous prostate surgery or other invasive treatment for BPH. 14. Had prior radiation to the pelvis. 15. Has Parkinson s disease or multiple sclerosis. 16. Had stroke or myocardial infarction within 5 months before Baseline. 17. Has clinically significant abnormal screening electrocardiogram (ECG) or unstable angina or severe congestive heart failure. 18. Has active liver disease with aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) > 2 times ULN, unexplained alkaline phosphatase > 3 times ULN, total bilirubin > ULN, renal insufficiency with creatinine > 1.7 mg/dl, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count. 19. Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2 minutes in a standing position. 20. Received alpha blocker therapy within 28 days before Baseline. 21. Received androgens, anti-androgens, 5-alpha reductase inhibitors, or luteinizing hormone-releasing hormone (LHRH) analogs within 3 months before Baseline. 22. Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline. 23. Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline. 24. Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise are not on stable doses of phosphodiesterase-5 inhibitors during the 4 weeks before Screening. 25. Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years. 26. Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Clinical Investigator s Brochure for AUS-131 [S-equol]), to be an unsuitable candidate to receive the study drug. 27. Has tested positive on the urine drug screen. Patients who test positive at Screening and can produce documentation from their physician for the medication that caused the positive test may be considered for study enrollment at the discretion of the investigator. 28. Has significant difficulties swallowing capsules or is unable to page 5 / 7

6 Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Pre-numbered or coded identical Containers Participant and Investigator Blinded tolerate oral medication. 29. Has participated in another clinical trial or received any investigational drug or device or investigational therapy within 30 days before Screening. Primary Outcome Outcome Timepoints The primary efficacy endpoint is the change from Baseline in PSA concentration at the Week 4 Visit (V5). Day 28 ±2 days Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary The secondary endpoints are the following: Change from Baseline in prostate size Change from Baseline in prostate size (assessed Change from Baseline in Qmax by transrectal ultrasonography) Change from Baseline in Qmax Percent of patients with change from Baseline in Qmax 2 cc/sec Percent of patients with change from Baseline in Qmax 30% Change from Baseline in PSA concentration Change from Baseline in PSA density Total Sample Size=124 Sample Size from =50 22/05/ /08/2010 Years=0 Months=8 Days=0 Open to Recruitment Other (Terminated) The preclinical and clinical data available indicate that AUS-131 is well tolerated and presents an acceptable risk-to-benefit ratio to the patient. Two Phase 1 clinical studies have been completed. An acceptable safety profile was reported in both these studies. The TEAE for study drug were similar to placebo and only 2 mild TEAE (abdominal cramps and nausea) were considered related to study drug for both studies. Since the safety data is blinded it is not known if these TEAE are in the placebo or drug groups. The potential benefits of a potent ER-? agonist to effectively treat the symptoms of benign prostatic hyperplasia while providing minimal risk to the patient would be unprecedented. The PK data from the single dose Phase 1 study AUS-CT01, indicate that, based on the T1/2 for AUS-131, a BID dosing regimen is appropriate to ensure adequate systemic exposure at steady state. The PK data from the multidose Phase 1 study, AUS-CT02, confirmed a BID dosing regimen page 6 / 7

7 Powered by TCPDF ( PDF of Trial is appropriate. The 10, 50, and 150-mg BID doses in the current study are comparable to the dosing regimen in the 14-day AUS-CT02 study with dosing cohorts of 10, 20, 40, 80, or 160 mg BID. The older individuals (45-65 years) had different PK profiles compared to the younger group (18-44 years) in the single-dose Phase 1 study, AUS-CT01. However, the safety profile was similar between groups. Dose-normalized AUC0-12 and Cmax were not significantly different between the younger and older age groups, for single and steady state doses in the multidose Phase 1 study, AUS-CT02. The safety profile was similar between the older individuals compared to the younger individuals for both studies which suggest the safety profile for the Phase 2 studies will be similar to those reported in the Phase 1 studies. page 7 / 7