SAN DIEGO, CA, Nov. 22 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation today provided an update on HspE7, the Company’s investigational therapeutic vaccine candidate for human papillomavirus (HPV)-related diseases, following a meeting with the U.S. Food and Drug Administration (FDA). The goal of the meeting was to discuss the Company’s clinical development strategy for the reformulated HspE7, which is now being combined with Poly-ICLC, an adjuvant that activates innate immunity and targets the Toll-like receptor 3 (TLR-3) pathway.
The Company received positive feedback from FDA on the following topics: 1. Nventa’s proposed approach to combining HspE7 with the adjuvant Poly-ICLC; 2. Nventa’s proposal to submit an amendment to the original IND for the development of HspE7; 3. Nventa’s proposed Phase I study design in patients with cervical dysplasia (CIN), including high-grade (CIN II and CIN III) and low-grade dysplasia (CIN I); 4. Nventa’s preclinical studies and data relating to HspE7 combined with Poly-ICLC that may be required before the initiation of a Phase I study; 5. Nventa’s proposed approach to evaluating the biological potency of HspE7; 6. Nventa’s proposal to cross-reference third-party Investigational New Drug applications (INDs) for information on Poly-ICLC; and 7. Nventa’s proposal to commence Phase II studies in CIN and/or other HPV-related indications following successful completion of a Phase I clinical trial in CIN.
As a result of the meeting with FDA, Nventa expects to file an amendment to its IND by the first quarter of 2007, and commence the Phase I clinical trial of HspE7 plus adjuvant during the first half of 2007, pending approval from FDA of an amendment to the IND originally submitted and approved for HspE7 alone, and pending receipt of adequate corporate funding.
“We are very pleased with the clarity the FDA has provided regarding the regulatory path necessary to re-commence clinical development of our lead program, HspE7,” said Gregory M. McKee, Nventa’s President and Chief Executive Officer. “With this affirmative dialogue with the FDA, we are now more confident in our ability to secure the funding necessary to proceed not only with this program but also to begin to progress our other promising product pipeline opportunities.”
About Nventa Biopharmaceuticals 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 Biopharmaceuticals Corporation, please visit the Company’s website located at 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”, “estimate”, “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 combination of an adjuvant with our reformulated HspE7, the filing of an amendment to our IND by the first quarter of 2007, commencement of a Phase 1 clinical trial of HspE7 plus adjuvant during the first half of 2007 and obtaining necessary funding.
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 ability to continue as a going concern; 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 and ultimately marketed; 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 and/or market the product successfully; 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; uncertainties as to future expense levels and the possibility of unanticipated costs or expenses or cost overruns; our ability to attract and retain key personnel; our ability to protect and practice our intellectual property; the risk that competitors may develop and market drugs that are less expensive, more effective or safer than ours; 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 planned trials; that we will be able to procure the necessary amount of adjuvant to conduct planned trials; that if conducted, the results of our Phase I trial will be favorable; that we will obtain timely approval from IRB; that the results from additional pre-clinical work, if any, will be consistent with the results we have already obtained; that the Antigenics appeal will be unsuccessful; that a sufficient number of patients will be available to conduct a successful clinical trial; 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, or at all.
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, Tel: (858) 202-4900, Fax: (858) 450-6849, dslade@nventacorp.com
Nventa Biopharmaceuticals Corporation
CONTACT: Donna Slade, Director, Investor Relations, 6055 Lusk Boulevard,San Diego, CA, USA, 92121, Tel: (858) 202-4900, Fax: (858) 450-6849,dslade@nventacorp.com
