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news.Nventa Biopharmaceuticals has announced the completion of the safety and tolerability assessment of the fourth and final cohort of patients in its Phase I clinical trial of HspE7, its lead therapeutic candidate, in women with cervical intraepithelial neoplasia.
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Findings from the fourth cohort safety review demonstrated that HspE7 was safe and well-tolerated with no serious adverse events being reported.
In addition to safety data, immunological data were collected from all patients pre-treatment, following each dose of HspE7 and at the end of the study. Preliminary evaluation of biological samples collected from the study’s first and second cohorts indicates that administration of HspE7 results in an E7-specific T-cell immune response. Independent research findings demonstrate that such an immune response may be associated with objective clinical responses in patients with cervical intraepithelial neoplasia (CIN). Therefore, Nventa believes that HspE7 may successfully treat CIN by activating and enhancing the body’s natural immune system. The company expects to release immunological data from the third and fourth cohorts in the coming months.
Gregory McKee, president and CEO at Nventa, said: “We are pleased with the broad safety and initial activity observed in our phase I trial for HspE7, and are increasingly optimistic about the drug’s potential to treat both high-grade and low-grade CIN. We are currently finalizing the design for a phase II trial of HspE7 and expect to initiate enrollment by mid-2008.”