Vaccinogen Believes That Its "Whole-Tumor Methodology" and Focus on "Cancer Heterogeneity" is Supported by Research Published in The Proceedings of the National Academy of Sciences (PNAS)
Peer-Reviewed Article Concludes That Extreme Intratumor Diversity, Even in Small Tumors, Suggests a Need to Reevaluate Treatment Strategies
Dec 2, 2015
BALTIMORE, Dec. 2, 2015 /PRNewswire/ -- Vaccinogen, Inc. (OTC.QB: VGEN), a cancer immunotherapy development company, believes that an article published in The Proceedings of the National Academy of Sciences (PNAS) strongly supports the central thesis for the Company's OncoVAX® cancer immunotherapy platform and its whole-tumor methodology.
In a manuscript entitled, "Extremely high genetic diversity in a single tumor points to prevalence of non-Darwinian cell evolution," the authors reported on an examination of a single tumor by sequencing or genotyping nearly 300 regions from the tumor. The researchers estimated that more than 100 million coding region mutations occurred in what is described as an unexceptional tumor. According to the authors, the extreme genetic diversity implies evolution under the non-Darwinian mode, suggesting that a high probability of drug resistance should be heeded, even in the treatment of microscopic tumors. Based on this assessment, the researchers conclude that the possibility of high intratumor diversity even in small tumors suggests a need to reevaluate treatment strategies.
Vaccinogen believes that these findings support its whole-tumor methodology and its OncoVAX® immunotherapy platform which was originally designed to address the extreme heterogeneity of cancer. This treatment strategy is intended to provide a personalized approach to immune-based treatment, thus mitigating the complication of inter- and intra-tumoral diversity. Currently the subject of a planned phase IIIb clinical trial in stage II colon cancer patients (ACTIVE), OncoVAX® is a proprietary method intended to use a patient's own tumor to prevent cancer from returning after surgery. Once removed, the tumor is taken apart cell by cell and manufactured into an injectable, sterile vaccine.
Andrew L. Tussing, Chairman and Chief Executive Officer of Vaccinogen, stated, "The importance of this research cannot be understated, and I would like to applaud the research team and PNAS for this extremely enlightening paper on the heterogeneity of cancer cells. As noted in the study, patient survival has been shown to be negatively correlated with the level of genetic diversity within tumors. This analysis is precisely the thesis upon which Vaccinogen's OncoVAX® platform was designed."
Mr. Tussing continued, "In contrast to 'off-the-shelf' immunotherapies that are not patient-specific, OncoVAX® is an autologous cancer vaccine manufactured with a patented process to leverage a patient's own live and metabolically active tumor cells to launch a potent and customized immune response against residual cancer cells that may reside in the body after surgery. Thus far, the clinical success of OncoVAX® has validated the assertion that addressing the heterogeneity of cancer requires a highly personalized approach to immune-based treatment. We anticipate this methodology will be reconfirmed in our ACTIVE phase IIIb clinical trial for stage II colon cancer."
The research article in The Proceedings of the National Academy of Sciences may be accessed via the following URL:http://www.pnas.org/content/early/2015/11/11/1519556112.abstract
About Vaccinogen, Inc.
Vaccinogen, Inc. is a cancer vaccine company planning to clinically test OncoVAX®, a treatment designed to prevent the recurrence of stage II colon cancer and potentially other solid tumors. It is a patented process intended to leverage a patient's own live tumor cells to launch a broad immune response against minimal residual disease. Vaccinogen believes that OncoVAX®, at an optimal dose and regimen, is the first colon cancer vaccine to demonstrate effectiveness in preventing cancer recurrence after surgical resection by addressing the diversity of cancer cells inherent to each patient's tumor. Five clinical studies of OncoVAX®, including a statistically significant phase III trial with the optimum dose and regimen, have been completed. Vaccinogen expects to begin enrolling patients in a pivotal phase IIIb trial under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) once adequate funding is obtained. Vaccinogen has also secured an option agreement to acquire a high-throughput, single-cell screening and analysis system known as DiCAST, which the company expects to use to screen patient-derived biological samples in order to accelerate its human monoclonal antibody (HuMab) program for the development of next-generation cancer vaccines and immunotherapies. More information is available at http://www.vaccinogeninc.com/.
Forward Looking Statement
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipates", "believe", "plan", "intend", "expect", "likely", "may", "should", "will" and similar references to future periods. Vaccinogen has based these forward-looking statements largely on its expectations and projections about future events and trends affecting the financial condition and/or operating results of our business. Forward-looking statements involve risks and uncertainties; particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and the risks associate with the company's continuing efforts to obtain adequate funding to pursue its goals. In addition, these forward-looking statements involve risks and uncertainties outlined in our most recent periodic reports filed with the Securities and Exchange Commission. There are important factors that could cause actual results to be substantially different from the results expressed or implied by these forward-looking statements. Therefore, you should not rely on these forward-looking statements. Vaccinogen does not undertake any obligation to update this forward-looking information
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