Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

Detailed Description
-----------------
This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte. The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Official Title
-----------------
A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Drug: BLS_ILS_E710c 500mg
* Drug: BLS_ILB_710c 1000mg
* Drug: BLS_ILS_E710c 1500mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal patients between age of 20 and 50. Patients with cervical intraepithelial neoplasia 3(CIN3). Only infection with HPV type 16. Patients with Capable of observation of all of lesions by Colposcopy biopsy. Be informed of the nature of the study and will give written informed consent. Be agree with contraception during study White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm^3 Normal for EKG(Electrocardiography) AST/ALT : 2.5 times less than normal range Exclusion Criteria: Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive. Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication. Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.) Investigational product within three months before the start of the drug administration to patients treated with other test drug. Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis. Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc. Pregnant or lactating women Patient with HBV or HCV infection (except for Asymptomatic) Patient that Investigator judge Deemed inappropriate for researchers to judge the patient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLS_ILB_E710c 500mg<br>Drug: BLS_ILB_E710c 500mg Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8) | Drug: BLS_ILS_E710c 500mg<br>* - 2 capsules per day for 20 days (week 1,2,4 & 8)<br>* Other names: CIN3 Theraputic Vaccine;|
| Experimental: BLS_ILS_E710c 1000mg<br>Drug: BLS_ILS_E710c 1000mg Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8) | Drug: BLS_ILB_710c 1000mg<br>* - 4 capsules per day for 20 days (week 1,2,4 & 8)<br>* Other names: CIN3 Theraputic Vaccine;|
| Experimental: BLS_ILS_E710c 1500mg<br>Drug: BLS_ILS_E710c 1500mg Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 & 8) | Drug: BLS_ILS_E710c 1500mg<br>* - 6 capsules per day for 8 weeks (week 1,2,4 & 8)<br>* Other names: CIN3 Theraputic Vaccine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 : Safety | Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0 | up to 9 weeks | 
| Phase 2a : Regression rate | Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal | screening and 9 weeks(option), 16 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9. | Phase 1 : up to 9 weeks | 
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks | Phase 2a : up to 16 weeks | 
| Serum anti-E7 antibody | Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks. | 1 week, 9 weeks, 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Cervical Intraepithelial Neoplasia(CIN3)