Medicare coverage of lung cancer screening for at-risk beneficiaries has been approved, begging the question of what the US healthcare system is going to do for therapeutic resources. Sanovas is pitching for a slice of the action with its Photodynamic Therapy solution.
Setting the scene, lung cancer is the leading cause of cancer death and the second-leading cause of all deaths in the U.S. Consequently, a few years ago the National Cancer Institute undertook the so-called National Lung Screening Trial, to assess the impact a screening program might have. Based on that data the U.S. Center for Medicare & Medicaid Services (CMS) has mandated that Medicare coverage of low-dose CT lung cancer screening for at-risk beneficiaries will be required by law from the beginning of 2015… which is now. All of a sudden, approximately four million Medicare beneficiaries find themselves in the tent, fitting the eligibility criteria for screening, according to the Lung Cancer Alliance (LCA).
Screening at-risk Medicare beneficiaries with CT scans undoubtedly has the potential to reduce the number of deaths from lung cancer, otherwise they wouldn’t have gone down this road. However there’s a growing recognition that the U.S. healthcare system is going to be inundated with patients who have been diagnosed with early-stage lung cancer, picked up on CT scans,
Such is the etiology of the disease, patients who would otherwise have remained symptom free at the time of the scan, will find themselves requiring serious treatment. Commentators are pointing to a potential order-of-magnitude spike in the diagnosis of peripheral nodules, and with diagnosis comes the need to treat, leaving the question as to whether therapeutic resources will be fully available. And here lies the next problem: Cancers in the peripheral airways are by definition hard to reach, demanding small-diameter technologies to get to the periphery of the lung and then, once you get out there, delivery of some therapeutic solution in a highly specific manner.
Sanovas believes its capabilities will step up to the plate. The company claims its PhotoDynamic Therapy (PDT) is a much better option than systemic chemotherapy, being delivered locally and focally without having to toxify the entire patient to treat what can be a tiny, but metastasizing nodule.
Furthermore Sanovas believes its system addresses what is currently a significant unmet clinical need for a method of treating hypoxic malignant tumors that is capable of delivering an oxygenating agent directly to target tumor tissue. All of this within the bodily cavity and needing to deliver more precise and efficient oxygenation of the target tumor site, without exposing the surrounding healthy tissue to potentially damaging chemical agents.
There has been a core of people advocating PDT for peripheral lung cancer for almost 15 years, many advocating it as the only evidence-based intervention that makes sense for carcinoma in situ for early stage lung cancer. One such is Dr. Gordon Downie, a former British Olympian and former Associate Professor of Pulmonary and Critical Care Medicine at the Brody School of Medicine at East Carolina University, and a clinical adviser to Sanovas. Dr Downie is widely published on the subject recognized as one of the foremost authorities on the use of PhotoDynamic Therapy in the lungs.
“No doubt, the diagnosis of peripheral tumors is going to proliferate as lung cancer screening becomes mainstream,” says Dr. Downie. “Challenges facing the clinician include protecting lung function in patients with already compromised abilities, optimal targeting of therapy to avoid serious injury to normal structures, real-time confirmation of clinical effectiveness, non-mutanegenic or carcinogenic tumorcidal agents, and the ability to assess for tissue hypoxia. Locally/regionally delivered and activated PDT can address all these challenges,” he adds.
“First, a directly observed delivery system ensures a concentration gradient favoring tumor kill over normal structure side effects. Second, the biochemical PDT reaction allows direct correlation of drug consumption with clinical real-time response. Because oxygen is also required for the PDT reaction, drug consumption can act as a surrogate marker for tissue oxygenation. Third, in my experience, I have never seen a primary lung tumor or any metastatic tumor to the lung be resistant to the PDT tumorcidal effect, and the reaction is neither mutagenic nor carcinogenic,” Dr. Downie says.
“One of the most common problems encountered during radiation therapy of malignant tumors is that the tumor cells become deficient in oxygen – a condition referred to as hypoxia,” explains Dr. Downie. “It looks promising that the Sanovas PDT technology addresses the hypoxia dilemma. As a long-time proponent of using PDT technology to address peripheral lung tumors, I am truly excited by the potential this approach could lead to.”
“This is especially promising for Lung Cancer, which is among the most recalcitrant cancers in the world and, by far, the deadliest of all. The recently issued PDT patent to Sanovas represents a milestone event toward a more targeted and less-invasive treatment for cancer and one that promises to mitigate the deleterious side effects of cancer treatment that we have become all too familiar with. Sanovas PDT solution is arriving just in time to meet this expected inundation of early stage Lung Cancer patients.”