GL-ONC1, the Company’s leading viral vector, has been tested in more than 40 individual solid tumor types as a single-agent therapy including Breast, Mesothelioma, Melanoma, Pancreatic, Ovarian, Prostate, Lung, Anaplastic Thyroid, Colon, Squamous Cell Carcinoma and Liver cancer. It has shown a remarkable ability to safely enter, regress and eliminate tumors in these preclinical studies, leading the company to undertake a series of Phase I and Phase I/II human clinical trials. A wide array of additional viral vectors is also under preclinical evaluation for single agent (mono) therapy and proving to have similarly impressive safety and efficacy profiles.
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GL-ONC1 in Breast Cancer
A pivotal preclinical study published in Cancer Research (October 2007), shows GL-ONC1 administered alone (as a single agent therapy) eradicated 95% of human breast tumors within 130 days with no observed toxicity or safety concerns. Importantly, anti-tumor immune activity was documented as the oncolytic process triggered an innate immune response against the cancer in laboratory animals. Moreover, colonization, amplification, regression and elimination of the tumor were observed clearly through optic imaging of Green Fluorescent Protein (GFP) with which GL-ONC1 is encoded. This provides compelling visual preclinical evidence of the oncolytic process and its therapeutic effects.
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GL-ONC1 in Melanoma
The graph below shows results for GL-ONC1 in mice bearing human melanoma xenografts. Within 45 days of intravenous virus injection, tumor growth was inhibited by more than 98% as compared to the control group. The melanoma tumors were eventually eradicated, demonstrating strong anti-tumor effect in animal models.
Treatment of Melanoma Xenografts in Nude Mice
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GL-ONC1 in Mesothelioma
The chest wall of a mouse treated with GL-ONC1 is completely mesothelioma tumor free (Top), while (Bottom) untreated mice continue to bear heavy tumor burdens. [Kelly K, et al. 2008. Human Gene Therapy]
Malignant pleural mesothelioma is a fatal disease with a median life expectancy of less than 14 months. In animal models bearing human mesothelioma tumors, GL-ONC1 was successful in treating the disease, clearing the chest wall completely.