Preliminary evaluation of biological samples collected from the study’s first and second cohorts indicated that administration of HspE7 results in an E7-specific T-cell immune response. Nventa believes that HspE7 may successfully treat cervical intraepithelial neoplasia (CIN) by activating and enhancing the body’s natural immune system.
As previously reported, doses administered in both study cohorts were found to be safe and well tolerated, with no serious adverse events being reported in either group. Cohort 1 was designed to establish a baseline for the study with patients in this group being administered 500mcg of HspE7 and 50mcg of Poly-ICLC, a potent toll-like receptor 3 adjuvant. Consistent with previous preclinical studies conducted by Nventa, this dose level demonstrated anti-HspE7 antibody responses but limited T-cell responses.
In cohort 2, patients were administered 500mcg of HspE7 and 500 mcg of Poly-ICLC. In this group, three out of four patients showed anti-HspE7 antibody responses and HPV16 E7-specific T-cell responses. These findings verify the company’s predicted mechanism-of-action of HspE7 as demonstrated by early preclinical models and support the compound’s potential to treat HPV-16 induced CIN.
Nventa is currently working with the FDA to finalize trial design for the company’s Phase II clinical study for HspE7, and expects to initiate this trial in patients in CIN in mid-2008. In addition to CIN, Nventa is currently evaluating HspE7 as a potential treatment for a broad range of HPV-related pre-cancerous and cancerous diseases, and has a platform to generate other compounds that may treat a variety of other viral associated diseases.
Gregory McKee, president and CEO of Nventa, said: “We look forward to reviewing the immunological data from the remaining two cohorts of this study to determine if yet higher doses of HspE7 will improve the drug’s immunological activity.”