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GlobeImmune Expands GI-5005-02 Phase 2b Trial to Include Additional Treatment Naive IL28B T/T Subjects With Chronic Genotype 1 HCV
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The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype, and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.
"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."
"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."
Additional data from the original 140 subjects enrolled in the trial was presented at the 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
The design of the clinical trial expansion is identical to the original GI-5005-02 trial and will be conducted in approximately 30 of the participating U.S. sites. The primary endpoint of the randomized, open-label expansion study is sustained virologic response (SVR).
"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."
"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."
Additional data from the original 140 subjects enrolled in the trial was presented at the 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
The design of the clinical trial expansion is identical to the original GI-5005-02 trial and will be conducted in approximately 30 of the participating U.S. sites. The primary endpoint of the randomized, open-label expansion study is sustained virologic response (SVR).
