Nventa Completes Safety Evaluation on Final Cohort in HspE7 Phase 1Cervical Dysplasia Trial- HspE7 Phase 2 Trial for Cervical Dysplasia to Begin Mid-2008 -
SAN DIEGO, April 24, 2008 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation today announced the completion of the safety and tolerability assessment of the fourth and final cohort of patients in its Phase 1 clinical trial of HspE7, its lead therapeutic candidate, in women with cervical intraepithelial neoplasia (CIN). Findings from the fourth cohort safety review demonstrated that HspE7 was safe and well tolerated with no serious adverse events being reported.
An evaluation by the Safety Review Committee was performed after each of the four cohorts reached five weeks of treatment (two doses plus one week of follow-up). All of the patients in the Phase 1 study were administered 500 mcg of HspE7 with each of the four cohorts receiving escalating doses of adjuvant -- 50, 500, 1,000 and 2,000 mcg. The company previously announced that HspE7 was also well tolerated in the first three cohorts.
In addition to safety data, immunological data were collected from all patients pre-treatment, following each dose of HspE7 and at the end of the study. Preliminary evaluation of biological samples collected from the study's first and second cohorts indicates that administration of HspE7 results in an E7-specific T-cell immune response. Independent research findings published by Jeffrey Weber, M.D., Ph.D., in the journal Gynecologic Oncology demonstrate that such an immune response may be associated with objective clinical responses in patients with CIN. Therefore, Nventa believes that HspE7 may successfully treat CIN by activating and enhancing the body's natural immune system. The company expects to release immunological data from the third and fourth cohorts in the coming months.
"We are pleased with the broad safety and initial activity observed in our Phase 1 trial for HspE7, and are increasingly optimistic about the drug's potential to treat both high-grade and low-grade CIN," stated Gregory M. McKee, president and chief executive officer at Nventa. "We are currently finalizing the design for a Phase 2 trial of HspE7 and expect to initiate enrollment by mid-2008."
In addition to CIN, Nventa is currently evaluating HspE7 as a potential treatment for a broad range of HPV-related pre-cancerous and cancerous diseases.
About Phase 1 Trial Design:
This Phase 1 trial was designed to administer HspE7 with escalating doses of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist, to four cohorts comprising a total of 17 patients with CIN to assess the safety and tolerability of HspE7 plus Poly-IC. All patients were administered 500 mcg of HspE7 with each of the four cohorts receiving escalating doses of adjuvant -- 50, 500, 1,000 and 2,000 mcg.
The company's lead candidate, HspE7, 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. HspE7 incorporates the proprietary adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist. 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 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.
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: that administration of HspE7 results in E7-specific T-cell immune responses; that immune response may be associated with objective clinical responses in patients with CIN; the belief that HspE7 may successfully treat CIN by activating and enhancing the body's natural immune system; expectations regarding the release of immunological data from the third and fourth cohorts and the timing of such release of immunological data; the drug's potential to treat both high-grade and low-grade CIN; the finalization of the design for a Phase 2 trial of HspE7; and expectations regarding the timing of initiating enrollment for a Phase 2 trial of 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; the possibility that our drug will not treat target diseases as intended; the possibility that we will not be able to recruit patients for our trials in a timely manner; 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 clinical trial results will be favorable; that our drug will treat target diseases as intended; 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.
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Posted: April 2008