3 out of 4 Patients in Cohort 2 Demonstrate T-Cell Responses Indicating
Potential HspE7 Therapeutic Benefit
SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced interim immunological data from the first two cohorts 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. 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 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 treat 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 500 mcg of HspE7 and 50 mcg of Poly-ICLC, a potent toll-like receptor 3 (TLR-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 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 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. HPV-16 is the most common subtype of the HPV virus and is responsible for a significant percentage of cases of CIN.
"We are very encouraged with the interim immunological results from our Phase 1 HspE7 trial as they demonstrate the anticipated immune response improvement from cohort 1 to cohort 2. We believe that these results may correlate to the activity of the drug in future clinical trials," said Gregory M. McKee, president and chief executive officer at Nventa. "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."
The company recently announced positive safety and tolerability findings from cohort 3 in this Phase 1 study, as well as the completion of enrollment and initiation of dosing for the study's fourth and final cohort. Safety and tolerability results from cohort 4 are expected in mid-April. In addition to safety findings, immunological samples for the study's third and fourth cohorts are presently being collected and evaluated, and such findings will be released in the next several months.
Nventa is currently working with the FDA to finalize trial design for the company's Phase 2 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.
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 U.S. Food and Drug Administration (FDA) for the treatment of any type of CIN.
The company's lead 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(TM) 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 the human papillomavirus (HPV). The company is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit http://www.nventacorp.com.
This press release contains statements which may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking statements or information may include financial and other projections as well as statements regarding the company's future plans, objectives, performance, revenues, growth, profits, operating expenses or the company's underlying assumptions. The words "may", "would", "could", "will", "likely", "expect," "anticipate," "intend", "plan", "forecast", "project", "estimate" and "believe" or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only predictions, and that the company's actual future results or performance may be materially different.
Forward-looking statements or information in this press release include, but are not limited to, statements or information concerning: that administration of HspE7 results in an E7-specific T-cell immune response; that such an immune response may be associated with objective clinical responses in patients with CIN; verification of the company's predicted mechanism-of-action of HspE7; that HspE7 may successfully treat CIN by activating and enhancing the body's natural immune system; the potential of HspE7 to treat HPV-16 induced CIN; that the results may correlate to the activity of the drug in future clinical trials; that safety and tolerability results from cohort 4 are expected in April; that immunological findings for the study's third and fourth cohorts will be released in the next several months; and initiation of the company's Phase 2 clinical study in patients with CIN in mid-2008.
Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments to be materially different from results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, the possibility that immunology responses may not be a predictor of clinical benefit; that immunological findings in our first two cohorts may not be consistent with findings from our third and fourth cohorts and future clinical studies; that safety and tolerability findings in our first three cohorts may not be consistent with findings from our fourth cohort and future clinical studies; that results from future clinical trials will not be consistent with our expectations; that we will not be able to recruit patients for our planned trials in a timely manner; our need for capital; risks associated with requirements for approvals by government agencies such as the FDA before products can be tested in clinical trials; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance development; risks associated with the requirement that a drug be found safe and effective after extensive clinical trials; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for obtaining clinical supply materials; our ability to attract and retain key personnel; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at http://www.sedar.com.
Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that immunology responses are a predictor of clinical benefit; that immunological findings in our first two cohorts will be consistent with findings from our third and fourth cohorts and future clinical studies; that safety and tolerability findings in our first two cohorts will be consistent with findings from our third and fourth cohorts and future clinical studies; that results from future clinical trials will be consistent with our expectations; that we will raise enough capital, on reasonable terms and in a timely manner; that we will retain our key personnel; that we will obtain the necessary regulatory approvals related to HspE7 and Poly-ICLC in a timely manner; that enough HspE7 and Poly-ICLC will be available to conduct our planned trials; that we will obtain timely approval from additional IRBs; that the results from additional preclinical and clinical work, if any, will be consistent with the results we have already obtained; that a sufficient number of patients will be available to conduct our planned trials; and that sufficient data will be generated to support our IND.
In the event that any of these assumptions prove to be incorrect, or in the event that we are impacted by any of the risks identified above, we may not be able to continue in our business as planned.
For a complete discussion of the assumptions, risks and uncertainties related to our business, you are encouraged to review our filings with Canadian securities regulatory authorities, including our 2007 Annual Information Form filed on SEDAR at http://www.sedar.com. Historical filings relating to the company prior to the completion of the Company's March 23, 2006 corporate reorganization may be reviewed on SEDAR at http://www.sedar.com under the SEDAR profile GVIC Communications Corp.
All forward-looking statements and information made herein are based on our current expectations as of the date hereof and we disclaim any intention or obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
|SOURCE Nventa Biopharmaceuticals Corporation|
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