Nventa Announces Final Data from HspE7 Phase 1 Cervical Dysplasia Trial
-- Company Provides Update to Phase 2 Development Plan --
SAN DIEGO, July 28, 2008 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation today announced that it has completed analysis of immunological data from all four cohorts of its Phase 1 clinical trial for HspE7, its lead product candidate. HspE7 is a therapeutic treatment for patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. The primary cause of CIN is infection with certain human papillomavirus (HPV) types, of which HPV16 is the most common. Based on an analysis of HPV16 E7-specific T-cell responses across all cohorts, Nventa has identified a dose regimen of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC, a toll-like receptor 3 (TLR3) adjuvant, for subsequent Phase 2 trials.
The purpose of the Phase 1 trial was to determine the safety, tolerability and immunogenicity of HspE7 plus escalating doses of adjuvant (50, 500, 1,000 and 2,000 mcg of Poly-ICLC). All dose regimens were found to be safe and well tolerated. Immunogenicity analysis demonstrated that the adjuvant potently enhanced HPV16 E7-specific T-cell responses in subjects who demonstrated no or low responses at baseline.
"This Phase 1 trial has not only demonstrated HspE7's excellent safety profile, it has also provided compelling data to support the immunologic activity of the compound and identified the appropriate dose regimen for our future trials," said Gregory M. McKee, president and chief executive officer at Nventa. "We are very encouraged by these results and believe that HspE7 may offer an important therapeutic benefit for the millions of women with CIN."
In the first cohort (500 mcg of HspE7 and 50 mcg of Poly-ICLC), which was designed to establish a baseline for the study, there was limited HPV16 E7-specific T-cell responses. In cohort 2 (500 mcg of HspE7 and 500 mcg of Poly-ICLC), three out of four patients showed HPV16 E7-specific T-cell responses. In the third cohort (500 mcg of HspE7 and 1,000 mcg of Poly-ICLC), HPV16 E7-specific T-cell responses were elicited in all four subjects and all of these T-cell responses represented significant changes from baseline, indicating that the responses were a direct result of treatment with HspE7. In the trial's fourth and final cohort (500 mcg of HspE7 and 2,000 mcg of Poly-ICLC), two of five patients had significant increases in HPV16 E7-specific T-cells from baseline while the remaining three patients maintained high levels of HPV16 E7-specific T-cells that were already present at baseline. The absolute levels of HPV16 E7-specific T-cells in patients in the fourth cohort were similar to levels observed in the third cohort. The data, therefore, support doses of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC as appropriate for advancing into Phase 2 studies.
Findings from this trial verify the company's predicted mechanism of action for HspE7 as demonstrated by early preclinical models and support the compound's potential to treat HPV16- induced CIN. HPV16 is the most common subtype of the HPV virus and is responsible for a significant percentage of cases of CIN.
Phase 2 Development Plan Update:
Following discussions with, and input from, the U.S. Food and Drug Administration (FDA), Nventa has finalized its protocol for a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial of HspE7 in patients with high-grade cervical dysplasia (CIN 2/3). Preparations have been made at approximately 40 clinical investigational sites in the U.S., Canada and Latin America. The company has also designed a Phase 2 trial of HspE7 in patients with low-grade cervical dysplasia (CIN 1). Evaluation of clinical investigational sites in Europe and Latin America are underway. The company intends to initiate one or both of these Phase 2 trials once it has secured necessary financing.
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 human papillomavirus (HPV) types, of which HPV16 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: our intent to use 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC in our Phase 2 trials; that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal dose regimen for advancing into Phase 2 trials; that HspE7 may offer an important therapeutic benefit for the millions of women with CIN; the potential of HspE7 to treat HPV16 induced CIN; and our intent to initiate a Phase 2 clinical trial in patients with CIN 2/3 and/or a Phase 2 clinical trial in patients with CIN 1 once we have secured necessary financing.
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 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is not the optimal dose regimen; the possibility that immunology responses may not be a predictor of clinical benefit; that immunological findings in our Phase 1 trial may not be consistent with findings from future clinical trials; that safety and tolerability findings in our Phase 1 trial may not be consistent with findings from future clinical trials; 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 http://www.sedar.com.
Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal dose regimen; that immunology responses are a predictor of clinical benefit; that immunological findings in our Phase 1 trial will be consistent with findings from future clinical trials; that safety and tolerability findings in our Phase 1 trial will be consistent with findings from future clinical trials; 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: July 2008