Nventa Announces Additional Positive Immunological Data From HspE7Phase 1 Cervical Dysplasia TrialAll Patients in Cohort 3 Demonstrated Improvement in T-Cell Responses Further Supporting the Therapeutic Potential of HspE7
SAN DIEGO, May 12, 2008 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation 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 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.
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(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 HPV. The company is publicly traded on the Toronto Stock Exchange under the symbol "NVN".
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 statements regarding the company's future plans, objectives, performance, growth or the company's underlying assumptions. The words "may", "would", "will", "expect," "intend", "plan", "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 expectations, 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 HspE7 is more active with an elevated does of adjuvant; that administration of HspE7 induces T-cell responses that are therapeutic; 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; that HspE7 may successfully induce a targeted immune response to effectively treat CIN; the potential of HspE7 to treat HPV-16 induced CIN; and initiation of our Phase 2 clinical study in patients with CIN 2/3 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 three cohorts may not be consistent with findings from our fourth cohort and future clinical studies; that safety and tolerability findings in all four cohorts may not be consistent with findings from 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, which may not be available on a timely basis, or at all; 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 candidate 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 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 three cohorts will be consistent with findings from our fourth cohort and future clinical studies; that safety and tolerability findings in all four cohorts will be consistent with findings from 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 sufficient HspE7 and Poly-ICLC will be available to conduct our planned clinical trials; that we will obtain timely approval from additional Investigational Review Boards; 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 Biologics License Application.
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.
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.
Posted: May 2008