Get the Job DONE!

Human clinical trials are the final phase of research done before a drug is approved for use.  This human clinical trial will enroll Type 1 diabetic volunteers to determine whether treatment with BCG can eliminate the abnormal T-cells in patients with Type 1 Diabetes and to determine the optimal dose and timing of BCG administration.  The FDA has approved the Investigational New Drug (IND) application and the clinical trial.

The United States Food and Drug Administration (FDA) Process:

Investigational New Drug (IND) - Status: Completed

The first step in the FDA process is to complete and submit an Investigational New Drug (IND) application.  This will allow doctors to test an experimental compound or treatment on humans. The IND includes pre-clinical animal data, formulation, delivery and suggested dosing that will be evaluated by the FDA for safety and efficacy.  If the application is approved, the candidate drug enters a Phase I clinical trial.

Phase I - Status: In Progress

Human clinical trials allow doctors the ability to test an experimental drug or treatment in a small group (10-20) of patients. The trial evaluates the drugs safety and identifies any side effects.  At the completion of a successful trial the candidate drug is allowed to enter a Phase II clinical trial. The trial information can be found at Clinicaltrials.gov website trial ID NCT00607230.

Phase II - Status: Starts upon Completion of Phase I, Estimated 36 Month Duration (Funding Needed)

Phase II trials are performed on larger groups (20-300) and in multiple locations.  They are designed to assess how well the drug works, as well as to continue Phase I safety assessments on more patients.  In this stage dose escalation and different intervals will be studied.  At the completion of a successful trial the candidate drug is allowed to enter a Phase III clinical trial.

Phase III - Status: Starts upon Completion of Phase II, Estimated 36 Month Duration (Funding Needed)

Phase III studies are randomized controlled multi-center trials on large patient groups (300–3,000 or more).  The trial is aimed at being the definitive assessment of how effective the drug is in comparison with current standard treatment and to identify any drug interactions.  Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

Why This Trial Can be Successful......

By using a drug that is already FDA approved, the upfront RISK of failure is greatly reduced.  The key to success for upcoming and future clinical trials has been to create and automate a blood test that can be used to monitor trial results.  This test will quickly identify effective dosing by allowing precise counting of the white blood cells before and after drug treatment.

Specialized, high volume blood monitoring equipment and software have been designed and configured to support the BCG Clinical Trial.  This will ensure the blood test results are accurately assessed.

Clinical Trial SUCCESS......

Upon successful completion of clinical trials, BCG will be labeled for use as a treatment for Type 1 Diabetes.  Findings from the BCG Clinical Trial will be published in science journals.