SAN DIEGO, March 11 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation today announced that the Company has completed enrollment and initiated dosing of the fourth and final cohort of patients in its Phase 1 dose escalation trial. This study examines the safety of its lead candidate, new HspE7 (HspE7 + Poly-ICLC, a toll-like receptor-3, or TLR3 agonist), in patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. New HspE7 is an investigational therapeutic vaccine targeting human papillomavirus (HPV)-related diseases.
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“Conclusion of enrollment in this study is a significant milestone for Nventa,” said Gregory M. McKee, President and Chief Executive Officer at Nventa. “We have spent considerable time analyzing the need for a fifth cohort in this study, and have determined that the fourth cohort dose level is likely optimal for future clinical trials. Following completion of this Phase 1 study, we anticipate launching a comprehensive Phase 2 program studying the safety and efficacy of new HspE7 in patients with CIN.”
When complete, the Phase 1 trial will have dosed four cohorts totaling seventeen patients with a fixed dose of 500 mcg of HspE7 and either 50, 500, 1,000 or 2,000 mcg of the adjuvant, Poly-ICLC. In addition to safety data, immunological data are being collected pre-treatment, following each dose of new HspE7, and at the end of the study from all patients, which could provide an early indication of potential activity of new HspE7. All patients are also being typed for class I and II human leukocyte antigen (HLA) subtypes, and are being evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.
Affiliations and investigators in this trial currently have included the Montefiore Medical Center; William D. Kolton, M.D. of San Diego, California; Linda Roman, M.D. of the University of Southern California (USC); Michael L. Twede, M.D. of the Salt Lake Women’s Center in Sandy, Utah; and Mark T. Saunders, M.D. at the Mt. Timpanogos Women’s Healthcare/Physician’s Research in Pleasant Grove, Utah.
About New HspE7:
The Company’s lead candidate, new HspE7 (HspE7 + Poly-ICLC), 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. New HspE7 contains the novel CoVal(TM) fusion protein, HspE7 co-administered with the adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist adjuvant. 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 new 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 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 http://www.nventacorp.com.
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 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 may 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 optimal dose level for future clinical trials; completion of the Phase 1 trial; the launching of a comprehensive Phase 2 program in patients with CIN; the number of cohorts and patients and the expected dosing amounts in the Phase 1 trial; and the collection and use of immunological data to indicate potential activity of new HspE7.
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, our need for capital; the outcomes of our clinical trials; 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; 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; 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 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 additional IRBs; 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 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 Communications Corp.
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, +1-858-202-4945,
dslade@nventacorp.com
Web site: http://www.nventacorp.com/
