NEW YORK -- Antigenics Inc. announces that it has initiated a multi-center Phase 1 clinical trial of AG-707, its next-generation therapeutic vaccine for genital herpes. The study will evaluate the safety of and immune response to AG-707 in patients with herpes simplex virus type 2 (HSV-2), an infection affecting one in five Americans over the age of 12.
"AG-707 is designed to stimulate a potent T-cell response against the virus to control and reduce the severity of infection," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "With this application of heat shock protein technology, our hope is to be able to provide an effective new treatment option for millions of people suffering from genital herpes."
AG-707 (recombinant heat shock protein 70 polyvalent peptide complex) is a heat shock protein (HSP)-based vaccine that is designed to activate the immune system to target HSV-2 infection in a broad population of patients. AG-707 consists of a recombinant human HSP complexed with 32 synthetic peptides that are representative of the relevant sequences, both functionally and structurally, of various HSV-2 proteins.
The single-blinded, dose-escalating Phase 1 trial will involve up to 84 patients who are infected with HSV-2 and have a documented history of clinically active genital herpes. Patients will be randomized to receive AG-707 alone; AG-707 in combination with a proprietary adjuvant (a substance designed to improve immune response to vaccination); placebo; or adjuvant alone. The trial is designed to sequentially evaluate the safety of three dose cohorts of AG-707. The study will determine the overall safety profile and immune response of AG-707 with and without the adjuvant, as well as evaluate immune response to AG-707 vaccination compared with immune response to placebo or adjuvant alone.
Genital herpes is a chronic infection caused primarily by herpes simplex virus type 2. After the initial infection, HSV-2 establishes a lifelong latent infection in nerve cells during which symptoms disappear, only to reappear at a later time. Epidemiological surveys estimate that 500,000 cases of new genital HSV infections occur each year in the United States, with at least 45 million individuals - or one in five Americans age 12 and over - already infected. The World Health Organization estimates that approximately 21 million people worldwide are infected each year. Most people infected with HSV-2 are not aware of their infection. Even if controlled with use of viral suppressive therapies, genital herpes remains a chronic disease with a potential of transmission to sexual partners. The National Institutes of Health recommends three approved products, which have combined annual sales in excess of $2.5 billion.
Antigenics is working to develop patient-specific immunotherapeutics and revolutionary treatments for cancers and infectious diseases.
Source: Antigenics Inc.