Nventa Completes Evaluation of Second Cohort in HspE7 Phase 1Cervical Dysplasia Trial
HspE7 Well-Tolerated; Safety Evaluation
Allows Advancement to Third Cohort
SAN DIEGO, California USA, Jan. 14, 2008 - Nventa Biopharmaceuticals Corporation (TSX:NVN) today announced the completion of the safety and tolerability assessment in its second cohort of patients in a Phase 1 clinical trial of new HspE7 in patients with cervical intraepithelial neoplasia (CIN). HspE7’s safety data were normal and met the limits prescribed in the trial protocol, allowing advancement to the third cohort of patients in the study.
The evaluation by the Safety Review Committee was performed after the second cohort reached five weeks of treatment (two doses plus one week of follow-up). The dosing of the third cohort of patients is expected shortly.
At the end of each cohort, Nventa is also collecting immunological data that may provide an early indication of potential efficacy of the compound. All patients are 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.
The trial is expected to dose up to 5 cohorts comprising twenty-four patients. The first cohort of patients was administered 500 mcg of HspE7 and 50 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist . The second cohort was administered 500 mcg of HspE7 and an escalated dose of 500 mcg of adjuvant. The third cohort will be administered 500 mcg of HspE7 and 1,000 mcg of adjuvant, and t he fourth cohort will be administered 500 mcg of HspE7 and 2,000 mcg of adjuvant. An additional cohort of six patients administered 1,000 mcg of HspE7 and 2,000 mcg of adjuvant may be added if deemed appropriate based on data from the previous four cohorts.
Following successful completion of this Phase 1 trial, the Company anticipates launching a Phase 2 clinical trial with new HspE7 in patients with high-grade cervical intraepithelial neoplasia ( CIN 2/3). The Company is also in discussions with clinical investigators regarding the design and implementation of a second Phase 2 trial with new HspE7 in patients that are HIV-positive with low-grade CIN.
Affiliations and investigators in this trial currently include 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 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™ 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 .
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 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 collection and use of immunological data to indicate efficacy of the compound; the number of cohorts and patients and the expected dosing amounts in the Phase 1 trial; successful completion of the Phase 1 trial; the launching of a Phase 2 clinical trial in patients with high-grade cervical intraepithelial neoplasia (CIN2/3); the possibility of a second Phase 2 trial in HIV-positive low-grade CIN patients .
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, the possibility that we will not be able to recruit patients for our trials in a timely manner; 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: 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 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 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.
Posted: January 2008