FAQs ABOUT THE INSPIRE STUDY

Q. WHAT IS THE PURPOSE OF THE INSPIRE STUDY?

A. The main purpose of this study is to find out if IRX-2 and the drugs that are given with it can help patients with oral cancer live longer without the cancer coming back. The study will also identify any side effects of IRX-2 and the drugs that are given with it.

Q. WHEN SHOULD I TALK WITH MY DOCTOR ABOUT THE INSPIRE STUDY?

A. If you are interested in possibly participating in the INSPIRE study, you should talk with your doctor as soon as possible, and definitely before your surgery is scheduled. The medications in the INSPIRE study have to be started before your surgery.

Q. WHAT IS IRX-2?

A. IRX-2 is made up of substances naturally found in the body. Blood cells in donations from healthy donors are used to produce these substances (proteins), which may be lacking in certain oral cancer patients and that scientists believe are important and necessary for a properly functioning immune system.

Q. ARE IRX-2 AND THE OTHER DRUGS IN THIS STUDY APPROVED FOR SALE?

A. No. IRX-2 is an investigational (experimental) medicine that has not been approved in any country. The INSPIRE study is an important step to be performed to see if IRX-2 is helpful and safe. The drugs given with IRX-2 are approved drugs, but they are approved for other uses. Their use with IRX-2 is also investigational; it is not known whether or not they will help fight oral cancer, although scientists believe that they may be helpful.

Q. WHY IS THERE INTEREST IN TESTING IRX-2 IN ORAL CANCER?

A. The immune system can fight cancer, but in patients with oral cancer, the immune system does not always work well enough to stop and reverse cancer growth. IRX-2, and the drugs given with it, are designed to correct certain problems with the immune system to help improve a patient’s ability to fight cancer.

Q. WILL EVERYONE IN THE STUDY BE TREATED WITH IRX-2?

A. No. Two out of every 3 patients in the study will be treated with IRX-2. Patients receiving IRX-2 will be determined randomly (by chance). One out of every 3 patients in the study will be treated only with the drugs given with IRX-2.

Q. CAN I BE TREATED WITH IRX-2 WITHOUT PARTICIPATING IN THE STUDY?

A. No. IRX-2 is not approved or commercially available. The IRX-2 treatment is available only to people participating in the INSPIRE study or in other studies that may be started in the future.

Q. I AM SCHEDULED FOR SURGERY SOON. CAN I GET IRX-2 AFTER MY SURGERY?

A. No. IRX-2 is designed to strengthen your immune system to fight tiny pockets of cancer cells that could remain after surgery. For that reason, the initial doses of IRX-2 are given before surgery. Subsequent doses of IRX-2 are given after surgery as boosters.

Q. IF I WANT TO PARTICIPATE IN THE INSPIRE STUDY, WILL I NEED TO DELAY MY SURGERY?

A. Participating in the INSPIRE study should not mean a significant delay in your surgery date. Because your schedule may differ, feel free to discuss this concern with your doctor.

Q. HOW LONG WILL THE STUDY LAST?

A. The study is intended to follow patients treated with IRX-2 for a prolonged time. How long you participate in the study will depend on how your disease responds to the study regimen, how you are feeling, and how well you tolerate the study drug(s) as determined by you and your doctor.

Q. WHO IS RESPONSIBLE FOR THE INSPIRE STUDY?

A. The INSPIRE study is being led by IRX Therapeutics, Inc., the biotechnology company that invented the IRX-2 treatment, and by doctors who are experts in treating oral cancer.

Q. THERE ARE NO STUDY SITES IN MY AREA. WILL SOMEONE HELP ME TRAVEL TO A STUDY SITE?

A. A visiting nurse may come to your house to administer study treatment if you do not live near a study site. Alternatively, accommodations will be provided or reimbursed for people who have to travel long distances to a study site. Other travel and living costs can be paid depending on the distance you have to travel and the situation.

Q. WHAT ARE THE NEXT STEPS IF I AM INTERESTED IN PARTICIPATING IN THE INSPIRE STUDY?

A. If you think you may want to participate in the INSPIRE study, you or your doctor can e-mail us at: INSPIRE@irxtherapeutics.com.

© 2016 IRX Therapeutics