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All in Cohort 3 Demonstrated Improvement in T-Cell Responses Further Supporting the Therapeutic Potential of HspE7
San Diego, CA, USA | May 12, 2008 | Nventa Biopharmaceuticals Corporation (TSX:NVN) today announced positive immunological data from the third cohort of its ongoing Phase 1 clinical trial of its lead product candidate, HspE7, in patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. HPV 16 E7-specific T-cell responses were elicited in all four subjects in the study’s third cohort following administration of 500 mcg of HspE7 and 1,000 mcg of Poly-ICLC, a potent toll-like receptor 3 (TLR-3) adjuvant. All T-cell responses represented significant changes from baseline, indicating that the responses were a direct result of treatment with HspE7. As previously announced, three out of four of the patients in cohort 2 (administered 500 mcg of HspE7 and 500 mcg of Poly-ICLC) demonstrated a T-cell response, which may validate that HspE7 is more active with an elevated dose of adjuvant.
“We continue to be very encouraged with the immunological results from our Phase 1 HspE7 trial as they demonstrate that administration of HspE7 induces T-cell responses that we believe to be therapeutic,” said Gregory M. McKee, president and chief executive officer at Nventa. “These positive immunological data, along with the safety data analyzed to date, provide a strong foundation for our Phase 2 trial expected to begin mid-2008."
Independent research findings recently published in the journal Gynecologic Oncology by Jeffrey Weber, M.D., Ph.D., associate director for clinical research at the University of Southern California’s Norris Comprehensive Cancer Center, demonstrated that such an immune response may be associated with objective clinical 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 types, of which HPV-16 is the most common. In the U.S., these infections are typically discovered through nearly 60 million Pap screens completed each year, at a cost of up to $6 billion. Each year in the U.S., an estimated 1.2 million women are diagnosed with low grade cervical dysplasia (CIN 1), 300,000 with high grade dysplasia (CIN 2/3) and 2.4 million with atypical squamous cells of undetermined significance (ASCUS). No therapies other than surgery are currently approved by the FDA for the treatment of any type of CIN.
About HspE7
The company’s lead product candidate, HspE7, is a novel therapeutic candidate intended for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. HspE7 incorporates the proprietary adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist. An adjuvant is a substance added to vaccines to improve immune responses against target antigens. HspE7 is derived from Nventa’s proprietary CoVal™ fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Nventa is developing HspE7 for multiple indications.
About Nventa Corporation
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by HPV. The company is publicly traded on the Toronto Stock Exchange under the symbol "NVN". For more information about Nventa, please visit www.nventacorp.com.
SOURCE: Nventa Biopharmaceuticals Corporation |
