Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, discussed today the proprietary Cell-in-a-Box® technology, being acquired from SG Austria, that was used for the pancreatic cancer clinical trial and may have an effect on downstream micro metastatic disease.
The proprietary Cell-in-a-Box® technology capsules, when used in combination with cytochrome P450 expressing cells, can be placed at the tumor site so that the cells inside the capsule can convert the drug ifosfamide. When the patient is subsequently injected with the chemotherapeutic drug ifosfamide, the encapsulated cells transform this prodrug into its active form, which kills the pancreatic cancer cells.
It is extremely difficult to diagnose pancreatic cancer early on. Approximately 26% of people diagnosed have pancreatic cancer that spreads into the regions beside the tumor and 52% of patients have metastatic disease spread to regional lymph nodes and the liver. From trial and use data, for all pancreatic cancer stages combined there is only a 26% survival rate at 1 year, whereas using Cell-in-a-Box® technology in the phase 1/2 clinical trial the 1-year survival rate was 36%, double that of the standard Gemzar® therapy 1-year results of 18%.
The advantage of this approach is that pancreatic tumors are locally delivered high concentrations of active drug, allowing a decrease to only one-third of the standard amount of ifosfamide, reducing toxic side effects such as nausea, diarrhea, bone marrow suppression and weight loss. Due to the advanced stage most pancreatic cancers are found in, an important question has been whether the reduced amount of drug used can have an effect on the few pancreatic cancer cells, called micro metastases, which leave the primary tumor and are found in organs "downstream" from the original pancreatic tumor.
Dr. Robert Ryan, Chief Executive Officer of Nuvilex, addressed this concern, "The most common site for metastatic pancreatic cancer is in liver. The clinical trial data supports the idea that the chemotherapeutic drug arrives at the liver and could treat micro metastases in that organ. This is because the chemotherapeutic drug will follow the same route along the blood vessels from the primary tumor in the pancreas to the liver. We hope in future trials to see greater effects on these small tumor cell islands where success will be measured by lowered pancreatic cancer recurrence. It's exciting also because a lower than standard ifosfamide clinical dose is anticipated, providing additional patient benefit. By killing the cancer cells and reducing damage to normal tissues, our objective to eliminate cancer and leave the patient healthier, stronger and better able to fight their disease will have been accomplished."