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Nventa Announces Additional Positive Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
Date:5/12/2008

linical responses in patients with CIN. Accordingly, Nventa believes that HspE7 may successfully induce a targeted immune response to effectively treat CIN.

As previously reported, HspE7 was found to be safe and well tolerated in all four study cohorts, with no serious adverse events being reported.

Cohort 1 was designed to establish a baseline for the study with patients in this group being administered 500 mcg of HspE7 and 50 mcg of Poly-ICLC. 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 500 mcg of HspE7 and 500 mcg of Poly-ICLC. In this group, 3 out of 4 patients showed anti-HspE7 antibody responses and HPV16 E7-specific T-cell responses. These findings, combined with the cohort 3 data announced today, provide additional evidence of 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. HPV-16 is the most common subtype of the HPV virus and is responsible for a significant percentage of cases of CIN.

Nventa is currently working with the U.S. Food and Drug Administration (FDA) to finalize the trial design for the company's Phase 2 clinical study for HspE7, which it expects to initiate in patients with high grade cervical dysplasia (CIN 2/3) 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.

About Cervical Intraepithelial Neoplasia (CIN):

CIN, also known as cervical dysplasia, is characterized by the presence in the cervix of abnormal cells that precede and can develop into cervical cancer. The primary cause of such abnormalities is infection with certain HPV
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SOURCE Nventa Biopharmaceuticals Corporation
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