Recruitment is now well underway in an interesting Phase II trial for REPLICor’s novel nucleic acid polymer, REP 2139-Ca, in combination with Pegasys™ (pegylated interferon alpha-2a) for Hepatitis B and D virus co-infection at the Hospital for Infectious Diseases “Toma Ciorba” in Chisinau, Moldova (1).
Nucleic acid polymers have been shown, in both preclinical and clinical trials, to clear serum hepatitis B virus surface antigen (HBsAg) and to act synergistically with established immunotherapeutic agents such as PEGylated interferon-alpha 2a or thymosin alpha-1. Clearance of HBsAg is known to be a critical step in the restoration of the host’s own immunological control of HBV infection.
The Hepatitis D virus (HDV) can propagate only in the presence of HBV as HBsAg is an essential component of the hepatitis D virus; therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.
Complications associated with simultaneous co-infection or superinfection with HDV can be significantly more severe compared to infection with HBV alone. This more aggressive form of hepatitis is associated with a more rapid progression to cirrhosis of the liver and an increased chance of developing liver cancer (2). Thus in combination with hepatitis B virus, hepatitis D has the highest mortality rate of all the hepatitis infections.
None of the currently marketed antiviral agents for HBV, whether used alone or in combination, has the ability to treat this co-infection. Hence there is an urgent and unmet need for therapies to treat co-infection with Hepatitis D and B viruses.
This early phase clinical study is examining the safety and efficacy of REP 2139-Ca therapy in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection. It will recruit 12 patients in total and involves 15 weeks of monotherapy with REP 2139-Ca, followed by 15 weeks of combination therapy with REP 2139-Ca and Pegasys™ followed by 33 weeks of consolidation therapy with Pegasys™ alone. REPLICor is a privately owned Canadian biopharmaceutical company developing a novel nucleic acid polymer (NAP) based antiviral technology that has the potential to revolutionize the treatment of patients with chronic hepatitis B as well as other viral infections (3).
REPLICor’s management team have chosen Clinical Accelerator – the CRO with particular knowledge and expertise of conducting trials in Central & Eastern Europe, Russia, Ukraine and Commonwealth Independent States – to place and conduct this important trial for them. The single site selected, in this case, is in Moldova; a country that is rapidly establishing itself with excellent credentials and results to conduct early phase trials, and Clinical Accelerator is very pleased to be able to work with the Principal Investigator Dr Victor Pantea, a local key opinion leader in Infectious diseases.
Clinical Accelerator always locates GCP-orientated sites with enthusiastic investigators who have the capability to conduct trials to high standards and challenging timelines at competitive rates of remuneration. Moreover, patients in our areas of operation are usually very happy to participate in clinical trials and research studies, facilitating effective recruitment and retention.
We look forward to a very successful outcome for REPLICor’s Phase II study in their quest to revolutionise the treatment of viral disease.
- A Study of the Safety and Efficacy of Combination Treatment with REP 2139-Ca and Pegasys™ in Patients With Hepatitis B / Hepatitis D Co-infection (http://clinicaltrials.gov/ct2/show/NCT02233075?term=Moldova&recr=Open&rank=14)
- Fattovich G, Giustina G, Christensen E et al. (March 2000). “Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B”. Gut 46 (3): 420–6.