First patient dosed in ISA’s phase 1 immunotherapy trial for chronic hepatitis B
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ISA Pharmaceuticals announced that the first patient has been treated in its first-in-human phase 1 trial of its novel immunotherapeutic agent intended as a “functional cure” for patients with chronic hepatitis B virus infection.
The HEP-PEP trial will examine the safety, tolerability and efficacy of three escalating doses of ISA Pharmaceuticals’ synthetic long peptide immunotherapy vaccine, ISA104, compared with placebo among patients with HBV.
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“We are excited by the progress we are making in this first-in-human trial and eager to learn the potential impact that ISA104-based therapy could have on patients suffering from chronic hepatitis B virus infection,” study investigators Sonja Buschow, PhD, and Dave Sprengers, MD, PhD, from Erasmus MC University Center in Rotterdam, the Netherlands, said in an ISA pharmaceuticals press release.
They added: “This study will allow us to determine how safety issues and immune responses in patients receiving ISA104 relate to those occurring by chance and to deepen our understanding of this promising new therapy, of HBV-directed immune responses and on novel HBV biomarkers.”
According to the company, the ISA104 agent is intended to create a strong and specific immune response against HBV “with the aim to functionally cure chronically infected patients.” ISA Pharmaceuticals has previously demonstrated the efficacy of its immunotherapy treatment using synthetic long peptides derived from HPV to treat patients that had been chronically infected with HPV16.
“We are delighted to announce that the first patient has been dosed with ISA104 in the HEB-PEP clinical study, marking an important milestone in our mission to develop an effective treatment for patients with chronic hepatitis B virus infection, a tremendous global health burden and a defined cause of liver cancer,” Leon Hooftman, MD, chief medical officer at ISA Pharmaceuticals, said in the release. “The study will provide crucial information on the safety and potential efficacy of ISA104, as we continue to advance our clinical programs with a focus on improving patient outcomes.”
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