- “Cancer, as we now know, is a disease caused by the uncontrolled growth of a single cell. This growth is unleashed by mutations—changes in DNA that specifically affect genes that incite unlimited cell growth…The secret to battling cancer, then, is to find means to prevent these mutations from occurring in susceptible cells, or to find means to eliminate the mutated cells without compromising normal growth. The conciseness of that statement belies the enormity of the task.” The Emperor of All Maladies: A Biography of Cancer, by Dr. Siddhartha Mukherjee (2010)
Nowhere is the dilemma of cancer research more profound than in understanding and interrupting the metastatic process, which accounts for 90% of the millions of cancer deaths each year. While considerable progress has been made in the decades-long war on cancer, there is a striking lack of good news in slowing down–let alone stopping–the metastatic process in solid tumor cancers.
After decades of research and hundreds of failed drugs, the FDA recently approved four cancer immunotherapy drugs which prolong the lives of patients with metastatic disease (Provenge, Keytruda, Yervoy, Opdivo). The mode of action for each of them is to sensitize white blood cells to target and attack specific cell signal pathways in the tumor microenvironment which flourishes once circulating tumor cells (CTCs) leave the primary tumor and extravasate at distant sites. These immunotherapies are the most significant advance in oncology treatment in decades, and offer the first glimmer of prolonged survival once a patient’s cancer has metastasized; but their cost ranges from $100,000 to $300,000 per patient.
On a parallel track, numerous clinical studies demonstrate that a reduction in the absolute number of CTCs in a patient’s blood correlates with favorable overall survival. This proposition holds true for all major types of cancer over a range of different drug regimens. In other words, if a patient’s CTC count drops from a “danger zone” of, say, 10 CTCs before a given cancer treatment begins, to a “safe zone” of less than 5 CTCs, they will live longer.
The ViatarTM Therapeutic Oncopheresis System is a new medical technology which is derived from those two paradigms. It utilizes mechanical filtration of whole blood as the therapy to remove CTCs, and a dosage regimen that will seek to achieve and maintain an absolute number of CTCs for a given cancer type within the “safe zone” which delimits the probability of favorable survival.
Our strategic goals for the ViatarTM Therapeutic Oncopheresis System are, first, to make metastatic cancer a chronic rather than fatal disease; and, second, to democratize the cost of cancer care as compared to the very expensive new immunotherapies. Toward that end, once this product is commercialized we plan to periodically revise our pricing schedule downward so that the ViatarTM Therapeutic Oncopheresis System is affordable by healthcare systems and a broad range of cancer patients.
Much like dialysis removes toxins from the blood, the ViatarTM Therapeutic Oncopheresis System employs mechanical filtration to purify a cancer patient’s blood of CTCs, but without the side effects of other cancer therapies and at a much lower cost. In bench testing, it does so by removing over 95% of CTCs using a proprietary method that indiscriminately separates tumor cells based on size and deformability (rather than the selective targeting which characterizes the new immunotherapy drugs).
Through upcoming pilot and pivotal clinical studies of breast, prostate and gastric cancer patients, we will determine whether a therapeutic regimen of three times per week, for up to 24 weeks, will suffice to drive and maintain a cancer patient’s CTC count in the “safe zone” that has been statistically shown to improve overall survival; or whether more or less frequent treatments would be advisable.