Viatar CTC Solutions Inc. is a medical technology company focused on the treatment of patients with metastatic cancer. Our lead product, the ViatarTM Therapeutic Oncopheresis System, removes circulating tumor cells from whole blood using label-free cross-flow filtration. Pending regulatory approval targeted for 2016, it will be used as a periodic therapy to improve overall survival for a wide range of solid tumor types such as lung, breast, colon, prostate and gastric cancers.
This proprietary technology also powers our liquid biopsy products, which are collection systems for use by genetic testing companies, researchers and medical oncologists that provide a greater quantity and purity of circulating tumor cells for their molecular analysis and personalized medicine objectives.
“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, 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.
Before 2014 the precise molecular biology mechanisms that guide the establishment of metastatic tumors was unknown. But then an MIT animal study concluded that CTCs emit signals which attract platelets, which then attract granulocytes (a subset of white blood cells) to form metastatic niches within two hours.
Significantly, that study also showed that interfering with the signal pathways for either CTCs, platelets or granulocytes stops the metastatic process.
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.
Our Solution for Cancer Therapy
The ViatarTM Therapeutic Oncopheresis System is a new medical technology based on the principle of removing the first essential element in the formation of metastatic tumors: CTCs.
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.
How It Works
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).
Upcoming Clinical Studies
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.
Our Solutions for Cancer Research and Personalized Medicine
The common limitation of current technology platforms for analyzing CTCs from a liquid biopsy is the rarity of CTCs which are present in a standard blood sample of 10 mL or less (which hinders the sensitivity of any analysis); and the overwhelming number of white blood cells as compared to CTCs (which reduces the specificity and purity of CTCs). In other words, even if a given CTC technology platform can recover all of the CTCs which might be present in a single milliliter of blood (say, 200 cells), unless they represent 5-10% of the total cells in the sample being analyzed by DNA sequencing or other genetic analysis techniques, the mutations present in those CTCs will be lost in the background as noise in relation to the normal DNA sequence represented by the white blood cells. So the problem to be solved is both quantity and purity of CTCs removed.
Using the same technology as the ViatarTM Therapeutic Oncopheresis System, we are developing two solutions for researchers and medical oncologists who wish to utilize a liquid biopsy as a more timely and frequent tool for analyzing CTCs from a patient’s blood.
- ViatarTM Molecular Diagnostics System is designed to collect and purify a statistically significant quantity of CTCs from up to 50 mL of blood as the “front end” for single cell DNA sequencing and other genetic analysis technologies used for research and to determine which drugs are suitable for a particular patient’s disease. Due to the rapidly declining cost of DNA sequencing, it is gaining favor as the technology of choice for research and new drug development related to the many variants of mutations in cancer cells. This analysis is critical in understanding the complex biology of cancer as the disease progresses, developing new drugs and crafting a personalized approach to treatment.
Our system is unique because it collects a far greater absolute quantity of CTCs from circulating blood (up to 50 mL, instead of just 10 mL or less) while also enhancing purity by reducing the number of white blood cells. The filter used in this application was recently chosen and is being incorporated into another company’s CTC device for up to 10 mL of blood.
- ViatarTM Oncopheresis Liquid Biopsy System is designed for researchers and oncologists who seek to analyze CTCs from a very large volume liquid biopsy. It will collect and purify a massive quantity of CTCs from up to 10 liters of blood for input into next generation DNA sequencing instruments. It will be a less expensive and burdensome solution to the current approach of using leukapheresis to collect CTCs, which entails first removing and discarding the buffy coat (which contains all of a patient’s white blood cells, platelets, albumin and other vital blood components). By contrast, the ViatarTM Oncopheresis Liquid Biopsy System is aimed at separating primarily just CTCs, while returning to the patient their normal blood components. Its advantages will include being less expensive than leukapheresis and being repeatable at more frequent intervals, so that genetic testing companies, researchers and medical oncologists can obtain much more timely information about disease progression and response to a given therapy.