To all: This translational study aims to investigate the effect of IV administration of Reolysin in patients with colorectal cancer metastatic to the liver. These patients have advanced disease and are scheduled to have surgery to remove the metastatic liver deposits. The patients have agreed to undergo 5 days of Reolysin treatment in the 3 weeks before their surgery. The colon cancer metastatic lesions are surgically removed from the liver (with some normal surrounding liver tissue) and are handed over to the investigators. In part I of the evaluation, the tissues are evaluated for evidence of virus. The studies will likely involve microscope analysis, possibly electron microscope analysis, immune staining looking for virus and specifics of viral localization within the cells. This part of the evaluation will explore the ability of IV Reovirus to establish an ongoing infection in cancer cells and continue to propagate new virus and spread within a cancer mass. Immediately adjacent to the cancer mass are normal liver cells. This tissue acts as a perfect control in the evaluation of Reovirus in non-cancer tissue. In a single microscope slide, you should be able to compare cancer tissue (should sustain Reovirus infection) with normal adjacent liver tissue (shouldn't sustain Reovirus infection).
After an IV dose of Reovirus, the body should be able to completely clear the virus from all tissues within a day or two after the last administration. All of the patients in this study receive a 5 day course of Reovirus followed by a waiting period prior to surgery. The patients are broken up into those waiting 10-21 days and those who have surgery within 10 days of their Reovirus therapy.
This study investigates the ability of Reovirus to be delivered IV to metastatic deposits and subsequent propagation within susceptible tissue. Positive results would be an extremely convincing and compelling scientific argument supportive of the oncolytic effect of Reovirus. These "mechanism of action" (MOA) evaluations are extremely important to the FDA and are actually quite rare in licensing applications. Companies always point to potential MOAs but rarely have solid or convincing experimental data to back up claims.
Convincing knowledge of MOA will provide rationale to expand the range of Reovirus-treatable cancers. The mounting evidence of clinical effect will be assessed in light of the MOA. It will becomes easier and easier to attract investigators, patients and the attention of dance partners. This evaluation of the effect of IV Reolysin on colon cancer metastases could provide persuasive scientific proof supporting the observed clinical benefits. This whole story becomes a much stronger package with convincing MOA information.
If Reo 13 shows compelling evidence of selective Reovirus propagation in liver metastases, the MOA is largely cinched. A huge accomplishment! If Reo 13 were successful, the results would certainly be publishable in a significant journal. This would raise our visibility and provide and important validation of the science portion of the Reovirus program. More and more rays of light in our understanding!!
In addition, finding Reovirus in the colon cancer lesions suggests that metastatic colon cancer may be another susceptible disease within the Reovirus-treatment spectrum. About 50% of colon cancer will be Ras+ by mutation or other mechanisms of activation. Those patients with Ras+ tumors have a poorer prognosis and have more limited options for effective treatment. In the US and Canada, there are over 150,000 new cases of colorectal cancer per year and well over 1 million people who are currently living with colon cancer (SEER statistics). Add it up!!
Reo 13 hasn't received much attention, but if it is positive, it provides the fundamental rationale behind Reovirus treatment. It may not be appreciated by the majority of investors but don't underestimate the importance to your DD. Take notice.
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