Advanced Viral Research Corp. has submitted an Investigational New Drug (IND) Application with the US FDA last week to initiate a clinical development programme for the systemic use of AVR118 in patients with advanced malignancies.
"Submission of the IND for AVR118 represents a major milestone for the Company as it is a critical step in the commercial development of AVR118," Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. said adding, "We are eager to gain clinical exposure with the systemic use of AVR118 in the US Successful development of AVR118 could offer a new option for treating the symptoms of advanced cancer."
The first clinical trial is a phase II, multi-center study and will be conducted in the US. The trial will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease. Successful completion of this trial will then provide the platform to conduct further studies in patients with other complications of cancer.
ADVR's AVR118 is a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which, to date, has demonstrated a very favourable safety profile, appears to stimulate the pro-inflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis.