Stage 1: The first clinical program will evaluate InCell-RT in patients with recurrent ovarian cancer (ROC). Ovarian cancer is the sixth most common cancer in women, with approximately 22,000 new patients diagnosed in the US and 28,000 patients in the EU reported each year. Nearly all therapies for ovarian cancer kill cells by damaging DNA, but ovarian cancer cells can reconstitute their DNA repair mechanisms to the point where DNA damaging agents are no longer effective.
InCell-RT does not damage DNA - it destroys DNA in a manner that irreversibly leads to cell death. Thus, treatment resistance cannot occur, even in tumors with upregulated DNA repair mechanisms resulting from previous exposure to DNA damaging agents.
Stage 2: The second clinical program will evaluate InCell-RT in patients with high grade glioma (HGG), an indication that includes the most common malignant brain tumors. In the US alone, about 16,000 new cases of HGG are diagnosed each year, with similar incidence rates observed world-wide. Conventional radiotherapy techniques are too broad and non-specific to effectively kill locally-advanced HGG tumors without damaging healthy brain tissue; and many biologic and chemotherapy agents cannot effectively cross the blood-brain barrier. As there are very few dividing cells in the brain other than tumor cells, locally-administered 125I-UDR should selectively kill cancer cells without damaging the underlying brain tissue.
Stage 3: Additional clinical programs for various LAC indications will be developed following demonstration of the InCell-RT drug-device system in ROC and HGG. Potential indications include cancers of the head and neck, esophagus, pancreas, biliary tract, rectal/anal, urinary bladder, and prostate. In addition, InCell-RT could potentially be administered to patients with metastatic disease, providing palliative relief and improved quality of life for patients suffering from organ dysfunction, obstructions, and pain caused by local tumor involvement (e.g., palliation of esophageal obstruction allowing resumption of eating).