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 can help delay or prevent oral cancer from coming back after surgery. 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 an immunotherapy 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. These substances may help activate (turn on) the immune system to fight cancer.

Q. IS IRX-2 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.

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 there are problems with the immune system. IRX-2 is designed to help fix these problems with the immune system to help its ability to fight cancer.

Q. HOW CAN I PARTICIPATE IN THE INSPIRE STUDY?

A. For more information about taking part in the INSPIRE study, contact IRX Therapeutics at INSPIRE@IRXTherapeutics.com or contact one of the INSPIRE study centers listed here.

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. Patients in the study will be treated at intervals for 1 year. They will then be followed with occasional check-ups for a longer period of time.

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.

© 2017 IRX Therapeutics