We are currently conducting two clinical trials in the United States under separate Investigational New Drug (IND) applications with the FDA. We are evaluating the safety and effectiveness of FV-100 for the treatment of shingles in a Phase II clinical trial, and the safety and tolerability of INX-189 for the treatment of chronic hepatitis C in a Phase I clinical trial.

A clinical trial is a research study to answer specific questions about a new medicine or new ways of using known medicines. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. All new medicines must be tested in clinical trials, and proven to be safe and effective, before doctors can prescribe them.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as pharmaceutical companies, physicians, hospitals, and the government. Trials can take place in a variety of places, such as hospitals, universities, doctors' offices, or community clinics.

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

Randomization is a method, based on chance - like flipping a coin, where each participant is assigned to either a treatment or placebo. Usually, neither the participant nor the study doctors or nurses know what the participant receives.

Generally the sponsor of the study will tell participants what treatment they received when the study is over and the data have been analyzed.

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Most of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective?
• Has it been tested before?
• What kinds of tests are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working?
• Will results of the trials be provided to me?
• Who will be in charge of my care?