SAN DIEGO, May 12 Nventa BiopharmaceuticalsCorporation (TSX: NVN) today announced positive immunological data from thethird cohort of its ongoing Phase 1 clinical trial of its lead productcandidate, HspE7, in patients with cervical intraepithelial neoplasia, or CIN,a precursor to cervical cancer. HPV 16 E7-specific T-cell responses wereelicited in all four subjects in the study's third cohort followingadministration of 500 mcg of HspE7 and 1,000 mcg of Poly-ICLC, a potenttoll-like receptor 3 (TLR-3) adjuvant. All T-cell responses representedsignificant changes from baseline, indicating that the responses were a directresult of treatment with HspE7. As previously announced, three out of four ofthe patients in cohort 2 (administered 500 mcg of HspE7 and 500 mcg ofPoly-ICLC) demonstrated a T-cell response, which may validate that HspE7 ismore active with an elevated dose of adjuvant.
"We continue to be very encouraged with the immunological results from ourPhase 1 HspE7 trial as they demonstrate that administration of HspE7 inducesT-cell responses that we believe to be therapeutic," said Gregory M. McKee,president and chief executive officer at Nventa. "These positiveimmunological data, along with the safety data analyzed to date, provide astrong foundation for our Phase 2 trial expected to begin mid-2008."
Independent research findings recently published in the journalGynecologic Oncology by Jeffrey Weber, M.D., Ph.D., associate director forclinical research at the University of Southern California's NorrisComprehensive Cancer Center, demonstrated that such an immune response may beassociated with objective clinical responses in patients with CIN.Accordingly, Nventa believes that HspE7 may successfully induce a targetedimmune response to effectively treat CIN.
As previously reported, HspE7 was found to be safe and well tolerated inall four study cohorts, with no serious adverse events being reported.
Cohort 1 was designed to establish a baseline for the study with patientsin this group being administered 500 mcg of HspE7 and 50 mcg of Poly-ICLC.Consistent with previous preclinical studies conducted by Nventa, this doselevel demonstrated anti-HspE7 antibody responses but limited T-cell responses.In cohort 2, patients were administered 500 mcg of HspE7 and 500 mcg ofPoly-ICLC. In this group, 3 out of 4 patients showed anti-HspE7 antibodyresponses and HPV16 E7-specific T-cell responses. These findings, combinedwith the cohort 3 data announced today, provide additional evidence of thecompany's predicted mechanism-of-action of HspE7 as demonstrated by earlypreclinical models and support the compound's potential to treat HPV-16induced CIN. HPV-16 is the most common subtype of the HPV virus and isresponsible 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 studyfor HspE7, which it expects to initiate in patients with high grade cervicaldysplasia (CIN 2/3) in mid-2008. In addition to CIN, Nventa is currentlyevaluating HspE7 as a potential treatment for a broad range of HPV-relatedpre-cancerous and cancerous diseases, and has a platform to generate othercompounds 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 inthe cervix of abnormal cells that precede and can develop into cervicalcancer. The primary cause of such abnormalities is infection with certain HPVtypes, of which HPV-16 is the most common. In the U.S., these infections aretypically discovered through nearly 60 million Pap screens completed eachyear, at a cost of up to $6 billion. Each year in the U.S., an estimated