The objectives of the phase I clinical trial are to evaluate safety, pharmacokinetics and viral load in patients chronically infected with hepatitis C virus who have failed standard treatment. There are estimated to be 2.7 million people in the US and 170 million worldwide suffering from chronic hepatitis C infection.
Peregrine anticipates this to be a significant step in a continuing investigation into expanding the potential of Tarvacin. The company has already successfully applied to use Tarvacin in a study of patients with solid cancer; a trial for which enrollment is currently underway.
Peregrine will work closely with the FDA to address any questions that may arise during review of the anti-viral application. Patients will be enlisted once the clinical protocol has been accepted by the FDA and initiation of clinical sites has been completed.
Preclinical studies using Tarvacin for the treatment of viral diseases have yielded promising results in Lassa fever, influenza, and cytomegalovirus, which are included in a viral category called enveloped viruses. Based on Tarvacin’s anti-viral mechanism, the drug has potential for the treatment of enveloped viruses including hepatitis B and C, HIV, herpes, influenza including SARS and Avian flu. The treatment may also help combat potential bioterrorism threats such as marburg virus and lassa fever.
Tarvacin utilizes anti-phospholipid therapy technology, a novel approach to treating cancer, viral infections and certain ocular diseases. It is based on the finding that aminophospholipids, which are basic components of the inner surface of the cellular membrane, become exposed on the outside of the cellular membrane in response to certain disease states such as virally infected cells and cancer.