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AG-707 clinical trial in genital herpesProtocol C-400-01This section has been developed to answer commonly asked questions about the Phase 1 clinical trial evaluating AG-707 as a treatment for genital herpes such as:
What is AG-707?AG-707 is an investigational therapeutic vaccine designed to target the virus that causes genital herpes (herpes simplex virus type 2, or HSV-2). It is a nonpersonalized application of Antigenics’ heat shock protein (HSP) technology. Why is AG-707 being studied?Genital herpes is a serious public health problem that has no cure. A growing epidemic, HSV-2 infection affects more than 45 million people in the United States — or one in five Americans over the age of 12. Genital herpes is associated with more serious sexually transmitted diseases, especially HIV, because pathogens can gain easy access to the body through herpes lesions, which can recur up multiple times a year. The development of an effective therapeutic vaccine has the potential to offer new options to genital herpes patients, dramatically decrease the number of outbreaks, and control and reduce the severity of infection. How does AG-707 work?AG-707 is designed to target the HSP-peptide complexes to specialized immune cells so that the cells can take up the complexes, then present the antigenic peptides to the immune system. Presenting these peptides to the immune system is intended to activate both ‘helper’ and ‘killer’ T-cell responses against the genital herpes virus. This type of viral-specific immune response is considered crucial in fighting infections.
What will the AG-707 study be testing?The Phase 1 research study of AG-707 will be evaluating safety and immune response in patients with genital herpes.
Am I eligible for the research study with AG-707?Good candidates for the study are people with genital herpes who are not currently taking antiviral therapy. The best way to find out if you’re eligible is to speak with your doctor, who can help you determine if this study is right for you. If I enroll in the study, will I definitely receive AG-707?Patients enrolled in the study will be randomized to receive AG-707 alone; AG-707 in combination with an adjuvant; a placebo injection; or an injection of adjuvant alone. Because of the ratio at which patients are randomized to the different treatment arms in the trial, there is a 71 percent chance that you will receive AG-707 if you are enrolled in the study. Note that all study participants, regardless of the assigned treatment arm, will receive suppressive antiviral therapy in the event of an outbreak, which is the ‘standard of care’ for patients with genital herpes according to current medical guidelines. What is treatment with AG-707 like?Patients in the trial will receive one injection (of AG-707 alone; AG-707 in combination with adjuvant; placebo; or adjuvant alone) every two weeks, for a total of three doses. Shortly before treatment begins, study researchers will conduct blood tests, which will continue periodically for about seven months. Your doctor will review any potential side effects of therapy with you before treatment. Will my insurance cover the cost of participating in the study?While you are participating in the research study, any procedures that are required by the study protocol will either be covered by your insurance (as part of your usual medical care) or by Antigenics. Talk with your doctor for more details. How do I enroll in the study?If you are interested in enrolling in this study, speak with your doctor to find out if it’s right for you. For more information on the study, visit www.clinicaltrials.gov, or call the Antigenics Research Study Hotline toll-free at 866.805.8994. | ||||||||||
