SAN DIEGO, Oct. 8 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation today presented positive data from preclinical studies using its proprietary Toll-like Receptor 3 agonist, Poly IC-Poly Arginine (Poly-ICR), at the World Vaccine Congress 2008 in Lyon, France. Study results demonstrated Poly-ICR to be a potent vaccine adjuvant targeting the Toll-like Receptor 3 (TLR3) pathway. Data showed that Poly-ICR, in combination with model antigens, elicits strong anti-target antibody and CD8 T-cell immune responses. These findings demonstrate the versatility of Poly-ICR, suggesting that the compound may possess broad potential for use in both therapeutic and prophylactic vaccines.
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Additional study findings presented today by Peter Emtage, Ph.D., Nventa's vice president of research and development, include:
In addition to incorporating Poly-ICR into future internal product candidates, Nventa is pursuing the development of Poly-ICR for topical application for the treatment of genital warts (GW) and actinic keratosis, a premalignant condition of the skin.
The company is also currently providing access to Poly-ICR to multiple leading vaccine developers in the U.S. and abroad, who are evaluating Poly-ICR for potential use into a wide range of vaccine products.
"These findings have confirmed the potency of Poly-ICR and highlighted the broad applicability of this compound for potential use in therapeutic and prophylactic vaccines," said Gregory M. McKee, president and chief executive officer at Nventa. "While we are advancing Poly-ICR for our internal development and use, we've been extremely pleased with the interest in Poly-ICR that has been shown by outside parties. We are currently working with vaccine developers worldwide to enable their studies with Poly-ICR and we believe this product will evolve into a revenue generating opportunity for Nventa in the near future."
About Poly-ICR:
Poly-ICR is a Toll-like Receptor 3 (TLR3) agonist that when combined with a disease-specific antigen can induce both cytotoxic T-cell and antibody (B-cell) immune responses against that antigen. Cytotoxic T-cells, also referred to as CD8 T-cells, are required to target and eliminate pathogen- infected or cancerous cells. Antibodies, or B-cells, are required to protect against an infection caused by a pathogen. Poly-ICR, therefore, has potential utility in both the therapeutic and prophylactic areas of immunotherapy and vaccine development. This novel and potent immunomodulator works with the immune system to induce dendritic cell maturation, along with a broad range of inflammatory cytokines and chemokines, to facilitate the prevention and treatment of infectious diseases or cancer.
Data generated using Poly-ICR, in combination with a tumor-associated antigen, have demonstrated that the addition of the adjuvant potently increases the antigen-specific CD8 T-cell levels, which correlated with regression of tumors and prevention of tumor growth in mouse models. Poly-ICR is differentiated from other Poly IC compositions by its high stability and potency in human sera, as well as its consistency in physical-chemical properties. Nventa has successfully manufactured research and development lots of Poly-ICR and expects that its current manufacturing process can be used to produce future cGMP material.
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: Poly-ICR's potential for use in both therapeutic and prophylactic vaccines; our plans to incorporate Poly-ICR into future internal product candidates; the development of Poly-ICR for topical application for the treatment of GW and actinic keratosis; our belief that Poly-ICR will evolve into a revenue generating opportunity for Nventa in the near future; Poly-ICR's ability to induce both cytotoxic and antibody immune responses; and our expectation that our manufacturing process can be used to produce cGMP Poly-ICR.
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, that we may not be able to raise required capital; that we may not procure partners that use Poly-ICR in their vaccines and, if we do, that Poly-ICR will not be useful in such vaccines; that approvals by government agencies such as the FDA that are needed before products can be tested in clinical trials may not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance Poly-ICR; that Poly-ICR may not be found safe and effective after extensive clinical trials; that we may not be able to incorporate Poly-ICR into future internal product candidates; that it will not be possible to develop Poly-ICR for topical application for the treatment of GW or actinic keratosis; that Poly-ICR will not evolve into a revenue generating opportunity for Nventa in the near future or ever; our dependence on third parties to manufacture Poly-ICR; that our manufacturing processes may not be validated for use in producing cGMP materials; that we may not 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 be able to raise required capital; that we will procure partners that use Poly-ICR in their vaccines and that Poly-ICR will be useful in such vaccines; that approvals by government agencies such as the FDA that are needed before products can be tested in clinical trials will be obtained in a timely manner and in a manner that will not impair our ability to advance Poly-ICR; that Poly-ICR will be found safe and effective; that we will be able to incorporate Poly-ICR into future internal product candidates; that it will be possible to develop Poly-ICR for topical application for the treatment of GW and actinic keratosis; that Poly-ICR will evolve into a revenue generating opportunity for Nventa in the near future; that we will be able to engage third party manufacturers who will successfully manufacture Poly-ICR on reasonable terms and in a timely manner; that our manufacturing processes will be validated for use in producing cGMP materials; and that we will retain key personnel.
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 2007 Annual Information Form filed on SEDAR at http://www.sedar.com.
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 of Nventa
Biopharmaceuticals Corporation, +1-858-202-4945, dslade@nventacorp.com; or
Media, Tim Brons of Vida Communication, +1-415-675-7400,
tbrons@vidacommunication.com; or Michael Moore of The Equicom Group,
+1-416-815-0700, Ext. 241, mmoore@equicomgroup.com, both for Nventa
Biopharmaceuticals Corporation
Web site: http://www.nventacorp.com/
