Nventa Announces Publication of Final Results of a Phase 2 Study ofHspE7 in Cervical Dysplasia- 95% of Patients Had Regression or Stable Disease -
SAN DIEGO, CA, July 23, 2007 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation today announced the publication of final results, including new immunological data, from a Phase 2 clinical trial testing HspE7, the Company's lead therapeutic vaccine for human papillomavirus (HPV)-related diseases. The study was designed to determine the effects of vaccination with HspE7 in women with high-grade cervical intraepithelial neoplasia (CIN II/III), a precursor to cervical cancer. These data were published in Gynecologic Oncology on July 11, 2007.
The results of the trial showed that 95% of the patients had disease regression or their disease remained stable. Seven of 20 women (35%) had complete regression of their CIN II/III, 1 (5%) had regression to low-grade CIN (CIN I), 11 (55%) had stable disease and 1 (5%) had progression due to enlargement of her lesion. Importantly, immune responses were seen in 9 of the 17 (53%) women tested; 5 of the 7 (71%) complete responders had an immune response. Only 5 of 21 (23%) of the women had HPV-16 or -18 subtypes, suggesting that vaccination with HspE7 elicits cross-reactivity.
"HspE7, at this dose and schedule, clearly induced lesion regression in a substantial portion of women with high-grade cervical intraepithelial neoplasia," said Jeffrey Weber, M.D., Professor of Interdisciplinary Oncology at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. "The fact that regression was correlated with immune response suggests that enhancing the immunological effects of this vaccine may lead to improvement in the rate of lesion eradication."
"We believe that our Phase 1 trial in women with CIN testing new HspE7 (HspE7 dosed with an adjuvant) will demonstrate that the immunological effects of the vaccine are enhanced, implying a more potent drug," said Peter Emtage, Ph.D., Executive Vice President of Research and Development at Nventa. "Approximately two million women worldwide are infected with high-risk human papillomaviruses resulting in a substantial risk for the development of invasive genital malignancies."
Twenty-one women were prospectively entered into an IRB-approved Phase 2 study. All women had biopsy-proven high-grade cervical intraepithelial neoplasia and persistent post-biopsy lesions were visible by colposcopy. Four injections of HPV-16 HspE7 fusion protein at a dose of 500 micrograms per dose were given three weeks apart after which LLETZ was performed. Immune parameters were evaluated pre-vaccine and at the time of LLETZ, and HPV testing was performed at intervals before and after LLETZ. Study subjects were followed for 1 year after LLETZ. The study's endpoints included lesion regression, immune response and viral clearance.
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.
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 potential results of enhancing the immunological effects of the vaccine and that our Phase 1 trial in women with CIN testing new HspE7 will validate that the immunological effects of the vaccine are enhanced.
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 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, firstname.lastname@example.org
CONTACT: Donna Slade, Director, Investor Relations, 9381 Judicial Drive,San Diego, CA, USA, 92121, Dir: (858) 202-4945, email@example.com
Ticker Symbol: (Toronto:NVN.)
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Posted: July 2007