- Conference Call on September 13 to Discuss Phase 1 Trial and Other Major
SAN DIEGO, CA, Sept. 10 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation (TSX:NVN) today announced the initiation of its Phase 1 clinical trial to assess the safety and tolerability of new HspE7 (HspE7 dosed with an adjuvant) in 24 patients with cervical intraepithelial neoplasia (CIN). In addition to the key objective of assessing safety and tolerability, a secondary objective of the study is to assess T-cell and B-cell specific human papillomavirus (HPV)-E7 immune responses.
"Advancing our lead therapeutic vaccine program back into human clinical trials represents a major milestone for Nventa," said Peter Emtage, Ph.D., Vice President, Research and Development at Nventa. "Based on the impressive preclinical data collected to date using HspE7 combined with multiple adjuvants, we expect this trial to produce invaluable safety, tolerability and immunological biomarker data of new HspE7 for use in designing future efficacy trials."
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.
HspE7 + Adjuvant Phase 1 Trial Design:
The trial is a multicenter, nonrandomized, open-label Phase 1 safety study. The safety and tolerability of HspE7 and adjuvant administered concomitantly will be assessed following subcutaneous doses of HspE7 (500 mcg/dose) plus graduated doses of adjuvant in patients with CIN. An additional cohort administered a higher dose of HspE7 may be implemented if deemed appropriate by data from previous cohorts. Patients will be immunized every 28 days for a period of 8 weeks (3 administrations). Post-treatment evaluations will begin four weeks after the last of the three injections. Patients enrolled with high-grade CIN (CIN 2/3) disease will be eligible to undergo clinically appropriate treatment of the cervix at the twelfth week of the study.
Nventa will also collect immunological data from these patients that may provide an early indication of potential efficacy of the compound. To determine if HspE7 plus adjuvant elicit T-cell and B-cell specific HPV-E7 immune responses, all patients will be typed for class I and II human leukocyte antigen (HLA) subtypes, and will be evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.
Nventa will hold a conference call on Thursday, September, 13, 2007, at 9:00 am Eastern Time (6:00 am Pacific Time) to allow securities analysts and shareholders the opportunity to hear Management discuss an update on the progress with HspE7 and other important milestones.
Live Participant Dial In Numbers:
If you are in the U.S. or Canada call (Toll Free): 877 407-8031. If you
are International call: 201 689-8031.
Replay of Audio Portion:
A replay of this call will be available at 12:00 noon Eastern Time from
September 13 through 11:59 pm Eastern Time on September 20, 2007. The
playback number (Toll Free): 877-660-6853 (North America) or 201 612-
7415 (International), Account Number: 286; Conference Identification
Number: 254756 (both required for playback).
Nventa will also webcast its investor call on Thursday, September 13,
2007, at 9:00 am Eastern Time (6:00 am Pacific Time). The call is being
webcast by Vcall and can be accessed through Nventa's website at
http://www.nventacorp.com. Investors can also access the webcast at
http://www.InvestorCalendar.com. The webcast will be available for replay
through October 13, 2007.
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 HspE7 in combination 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. For more information about Nventa, please visit http://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", "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 value and use of data to be produced in the Phase 1 trial; the timing of announcing data from the Phase 1 trial; the launching of a Phase 2 clinical trial in CIN patients; the possibility of a second Phase 2 trial in HIV-positive CIN patients; the design of the Phase 1 trial; and the collection and use of immunological data to indicate efficacy of the compound.
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 http://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 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.
CONTACT: Donna Slade, Director, Investor Relations, 9381 Judicial Drive, Suite 180, San Diego, CA, USA, 92121, Dir: (858) 202-4945, firstname.lastname@example.org
|SOURCE Nventa Biopharmaceuticals Corporation|
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