The Hepatitis-B problem
400m people globally are chronically infected with Hepatitis-B with an estimated 3 million in Europe, 2 million USA and 120-140m in China. Chronic Hepatitis-B is a leading cause of liver cirrhosis and cancer with an overall long-term attributable mortality rate of 25%. Hepatitis-B virus exists as different genotypes; in Europe genotypes A & D, north America A, B, C & D and in Asia (esp. China) B & C predominate. The virus is genetically diverse and highly prone to mutation – one effective therapeutic vaccine for all genotypes would offer significant benefits to healthcare providers.
People meeting treatment criteria (in developed economies) face a poor prospect. Current standard of care (antiviral drugs +/- pegylated interferon-alpha) are expensive and only 30% effective. relapse rates are 50% within 12 months. Viral resistance to anti viral drugs is a major problem undermining therapy (0-70%).The unmet medical need is considered significant – with little hope for treatment improvements on the horizon.
Improving disease protection from Hepatitis-B
The goal of current standard of care treatment is to reduce viral load and permit seroconversion so subjects progress to an inactive state where liver disease progression is halted. Antiviral T-cell immunity is a key driver of this outcome.opinion leaders consider therapeutic vaccination plus standard of care will improve treatment outcomes and reduce reactivation rates by “actively reconstituting disease protective T-cell immune responses”.
Hepsyn B & Oncology
Hepsyn-B™ is a DepoVaccine product that contains eight Densigens which are derived from highly conserved regions of the Hepatitis B virus. The product is intended to provide therapeutic benefit to patients who are chronically infected with Hepatitis B of any of the four major sub-types (A-D).
In addition, ITS has used its bioinformatics discovery engine to design Densigens to a number of tumour associated antigens with the view to generating DepoVaccines exhibiting broad anti-tumour therapeutic activities.