Many solid cancerous tumors are known to be “treatment-resistant” to standard radiation and chemotherapy. Treatment-resistance occurs when cancerous tissue outgrows its blood supply, diminishing the available cellular oxygen necessary for effective therapeutic activity. Under normally oxygenated conditions, radiation and chemotherapy have a powerful killing effect upon cancerous tumor tissue. However, when the tumor tissue becomes oxygen-deprived (“hypoxic”), it is up to three times more resistant to the cancer-killing power of standard therapies. Many solid cancerous tumor types are hypoxic and therefore subject to this treatment-resistance. TSC safely re-oxygenates treatment-resistant hypoxic tumor tissue without affecting the oxygenation of normal tissue, thereby increasing therapeutic effectiveness without the addition of harmful side effects.
Many of the hypoxic tumor types targeted by the Company, including GBM, pancreatic cancer and brain metastases have been granted orphan drug designation by the FDA., meaning they affect no more than 200,000 patients in the United States. As such, they are allowed certain favorable treatments under FDA regulations in connection with exclusivity periods and the new drug approval process.