SAN DIEGO, CA, March 5 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation today announced the presentation of positive results from a clinical trial examining the safety and efficacy of pilot process HspE7, an investigational therapeutic vaccine for human papillomavirus (HPV)-related diseases, in women with the highest grade of cervical dysplasia (CIN III). The data from two posters were presented by Mark H. Einstein, M.D., the investigator in the trial and an expert in the field of cervical dysplasia, at the 37th Annual Meeting of the Society of Gynecological Oncologists in San Diego. The trial was conducted by the New York Cancer Consortium (an NCI-sponsored consortium) and the New York Gynecologic Oncology Group (NYGOG).
“This trial may lead to a paradigm shift in how select patients with high-grade CIN are treated,” said Mark H. Einstein, M.D. “The administration of HspE7 may be an attractive alternative to surgery for a subset of women with high-grade CIN. Placebo-controlled trials need to be performed to fully determine the treatment efficacy and to identify the appropriate subsets of women who may benefit from HspE7.” Dr. Einstein is Director of Clinical Research for the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology & Women’s Health at the Montefiore Medical Center at Albert Einstein College of Medicine.
Gregory M. McKee, President and Chief Executive Officer of Nventa commented on the study: “The data from this cervical dysplasia trial are consistent with other data in this indication that we have obtained from previous HspE7 trials. We are advancing a new formulation of HspE7 which has been shown to be more potent in preclinical testing and that may produce better results in future clinical trials. We expect to commence a Phase I bridging trial by mid-2007, pending submission of the final sections of an amendment to our original HspE7 Investigational New Drug application to the U.S. Food and Drug Administration.”
Trial Design
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The trial presented today was a single-arm, open-label, Phase II study to establish the response rate and safety profile of HspE7 in women with biopsy-proven CIN III. The secondary aim was to correlate clinical responses to HspE7 vaccination in women infected with HPV 16 compared to women infected with other HPV types. Responses to HspE7 were determined by pathology of post-vaccination Loop Electrosurgical Excision Procedure (LEEP) specimens. (LEEP is a standard procedure for patients with high grade dysplasia to remove the affected areas.) A pathologic complete response (pCR) was defined as a specimen negative for CIN. A partial response (PR) was determined by a 50 percent or more reduction of lesion size post-vaccination.
Trial Results
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71 patients were registered, of whom 62 were eligible after screening. 58 patients completed the trial and were evaluable (31 in cohort 1, 27 in cohort 2). There were no significant HPV type differences between the 2 cohorts so responses were combined for analysis. Of the 58 patients, 13 (22.5 percent) had a pCR; 32 (55 percent) had a PR and 11 (19 percent) had stable disease. Two (3.5 percent) patients in cohort 2 had microinvasive disease and were defined as progressive disease. The overall response rate was 45/58 (78 percent). 33/58 (57 percent) of the patients were infected with HPV 16 prior to vaccination or in subsequent visits. There was no significant difference in regression in women infected with HPV 16 compared to those without HPV 16 infection (88 percent vs. 70 percent; p=0.12). Similar responses were seen in patients infected with multiple HPV types compared to those infected with one type (p=0.20). HspE7 showed efficacy in patients infected with HPV types other than 16, suggesting cross-reactivity.
In a second presentation of data from the same cohort of 58 evaluable patients, CD4 and CD8 positive T cells were activated with pooled E6 and E7 peptides and tested for interferon gamma production and degranulation. Blinded histologic sections of the final cervical conization specimens were independently graded for inflammation using a standardized protocol (0 no inflammation and 4 the highest level of inflammation.). There was significantly more cervical inflammation in patients who did not undergo regression after HspE7 immunotherapy. Local inflammation did not correlate with type-specific HPV infection or systemic T cell responses to HPV peptides; however, this study may have been underpowered to predict these observations in this subset of women with heterogeneous T cell responses. Further studies are currently underway.
About HspE7, Lead Product Candidate:
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HspE7 is a novel therapeutic vaccine candidate for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. 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. Stress proteins, also known as heat shock proteins (Hsps), are naturally present in the human body and play important roles in the immune system, including transporting substances within cells and activating cells of the immune system. Nventa is pursuing clinical development of HspE7 in combination with an adjuvant.
About Nventa Corporation:
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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 corporation is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit www.nventacorp.com.
This press release contains statements which, to the extent that they are not recitations of historical fact 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 are intended to 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: the advancement of a new formulation of HspE7 that may produce better results in future clinical trials and our expectation that we will commence a Phase I bridging trial by mid-2007.
Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, 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 and the possibility that the results of such trials, if commenced and completed, will not establish the safety or efficacy of our products; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for negotiating supply agreements, corporate collaborations or licensing arrangements; our ability to attract and retain key personnel; our ability to protect and practice our intellectual property; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement.
Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, 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 our adjuvant in a timely manner; that enough HspE7 will be available to conduct out planned trials; that we will be able to procure the necessary amount of adjuvant to conduct our planned trials; that we will obtain timely approval from IRB; that the results from additional preclinical work, if any, will be consistent with the results we have already obtained; and that a sufficient number of patients will be available to conduct our planned trials; and that sufficient data will be generated to support an 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 2005 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, including Old Stressgen’s 2005 Annual Information Form dated March 16, 2006 may be reviewed on SEDAR at http://www.sedar.com under the SEDAR profile GVIC Publications Ltd.
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.
CONTACT: Donna Slade, Director, Investor Relations, 6055 Lusk Boulevard, San Diego, CA, USA, 92121, Dir: (858) 202-4945, dslade@nventacorp.com
Nventa Biopharmaceuticals Corporation
CONTACT: Donna Slade, Director, Investor Relations, 6055 Lusk Boulevard,San Diego, CA, USA, 92121, Dir: (858) 202-4945, dslade@nventacorp.com
