SEATTLE (February 25, 2011) – Etubics Corporation, a clinical-stage biotechnology company with a novel and proprietary Adenovirus Vector Vaccines Platform (AVVP) technology, entered into Phase II trials with its ETBX-011, a therapeutic immunotherapy candidate that is intended to treat Carcinoembryonic Antigen (CEA)-expressing cancers such as colorectal cancer.
Frank Jones, Ph.D., founder, Chairman and Chief Executive Officer of Etubics stated, “Our Phase I trials showed that there were no adverse affects to our therapy and we are eager to move into Phase II trials to learn more about the effectiveness of this product.”
Etubics Phase II CEA trial will be held at Duke University Medical Center in Durham, N.C. and Medical Oncology Associates, in Spokane, Wash. The study is designed to further understand the level of induction of anticancer immunity using ETBX-011. In the first phase of the Phase II trial, twelve patients will be vaccinated under the skin once every three weeks. After receiving three injections, patients will be monitored every three months for one year following treatment.
Etubics ETBX-011 utilizes a novel adenovirus serotype 5 (Ad5) vector platform technology, called Ad5 [E1, E2b-]-CEA. CEA represents an attractive target antigen for immunotherapy since it is over- expressed in nearly all colorectal cancers and pancreatic cancers, 70% of non-small cell lung cancers and approximately 50% of breast cancers. When tested against a conventional Ad5 platform, Etubics’ immunotherapy induced a significantly greater T-cell immune response in animals. Ad5 vectors have been used extensively in clinical studies but have been presented with the challenge of the patient’s own immunity against the vaccine itself. Pre-clinical and clinical data suggests that ETBX-011 may break through this barrier to induce a sufficient immune response.
Colorectal cancer, which expresses CEA, is the third leading cause of cancer-related deaths in the United States when men and women are considered separately, and the second leading cause when both sexes are combined. According to The American Cancer Society there were 106,100 new cases of colon cancer and 40,870 new cases of rectal cancer in the United States in 2009.
Etubics Phase II CEA trial has been funded entirely through grants from the National Cancer Institute (NCI). The NCI also awarded earlier grants to Etubics for its CEA pre-clinical and clinical work. For more information on this trial, please visit ClinicalTrials.gov.
Etubics Corporation, based in Seattle, Wash., is a next generation clinical stage bio-pharmaceutical company, which has developed a proprietary platform technology consisting of a next generation Adenovirus Vector Vaccine Platform and a manufacturing E.C7 human cell line, collectively the Etubics Platform. Clinical work to date shows that the Etubics Platform overcomes problems associated with existing adenovirus vectors. The Company’s Platform can be used to efficiently and rapidly develop immunotherapeutic drugs and preventive vaccines for a wide range of infectious diseases and cancers .
Statements herein relating to future financial, business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Etubics is a private company. Etubics cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including the failure by Etubics to secure and maintain relationships with collaborators; risks relating to the early state of Etubics’s product candidates under development; uncertainties relating to clinical trials and regulatory requirements and actions; risks relating to the commercialization, if any, of Etubics proposed product candidates; competitive risks to marketed products; dependence on the efforts of third parties; dependence on intellectual property; and risks that it may lack the financial resources and access to capital to fund its operations. Further information on the factors and risks that could affect Etubics’s offices, business, financial conditions and results of operations, are contained in Etubics’s documents on file at the Company. These forward-looking statements speak only as of the date of this press release and Etubics assumes no duty to update forward-looking statements.
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