SAN DIEGO, CA, Sept. 24 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation today announced the publication of in vivo results of its lead therapeutic vaccine candidate for the treatment of human papillomavirus (HPV)-related diseases, HspE7, in Clinical and Vaccine Immunology, August 2007. The results reported originate from a study undertaken to characterize the cellular anti-E7 immune response induced by HspE7 and to determine the optimum dosing regimen for inducing effective antitumor immunity.
These published study results demonstrated that a single injection of HspE7 is capable of eliciting long-lasting memory CD8+ T cells and conferring protection against tumor challenges in mice lacking CD4+ functions. CD8+ T cells are a type of white blood cell capable of inducing the death of infected somatic or tumor cells by killing cells infected with viruses (or other pathogens) or otherwise damaged or dysfunctional. These data further demonstrated that two HspE7 immunizations protected a higher proportion of mice for a longer duration.
“These results further strengthen our belief that HspE7 is a promising immunotherapeutic agent for treating HPV-related diseases,” said Peter Emtage, Ph.D., Vice President, Research and Development at Nventa. “The ability of HspE7 to induce memory CD8+ T cells in the absence of CD4+ help is significant and suggests that our HspE7 fusion protein may have utility in individuals with compromised CD4+ functions, such as those with invasive cancer and/or human immunodeficiency virus infection.”
HPV has been detected in most anogenital cancers, and HPV type 16 (HPV16) is closely associated with severe cervical dysplasia and with cervical, anal and approximately 25 percent of head and neck cancers. Evidence indicates that proper immunosurveillance can impede the development of HPV-associated tumors and that T-cell immunity is important in the resolution and control of HPV-induced diseases.
About HspE7, Lead Product Candidate:
------------------------------------
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. Heat shock proteins (Hsps), also known as stress proteins, 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 new HspE7 (HspE7 dosed with an adjuvant).
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 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: our HspE7 fusion protein’s potential utility in individuals with compromised CD4+ functions.
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 our 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 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 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 2006 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, 9381 Judicial Drive, San Diego, CA, USA 92121, Dir: (858) 202-4945, dslade@nventacorp.com
Nventa Biopharmaceuticals Corporation
CONTACT: Donna Slade, Director, Investor Relations, 9381 Judicial Drive,San Diego, CA, USA 92121, Dir: (858) 202-4945, dslade@nventacorp.com
