Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

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CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized tumors. The Company has developed a novel, polymer-encapsulated, membrane-like radiation source that emits radiation on only one side of the device – the CivaSheet. This directional source is compatible with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or combined cancer therapy. The CivaSheet is a partially bio-absorbable implant that can be applied at the time of the initial surgery. The CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the patient. Additionally, the CivaSheet can shield healthy tissues while irradiating the diseased tissue or tumor margin. This shielding enables the CivaSheet to be implanted close to radiosensitive structures without overdosing them – a potential advantage for cancers in the thorax. In Phase I, CivaTech Oncology will confirm the CivaSheet does not move after implantation and that excellent dosimetry can be achieved. The CivaSheet will be implanted during lung lobe segmentation or wedge resection – a standard of care procedure for lung cancer patients who cannot tolerate full lobectomy. The CivaSheet will benefit these patients by delivering radiation therapy at the time of initial surgery to minimize delay in the treatment. For lung cancer patients complete lobectomy is preferred for patients who can tolerate it. For those who cannot, radiation to the surgical margin is a potential benefit. In Phase I, the safety of CivaSheet and general recommendations for its use in this patient population will be assessed. Changes to the surgical implant technique will be assessed as well. The Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as boost radiation therapy in lung cancer patients. The rate of local recurrence in patients implanted with CivaSheet will be compared to the current rate of 20%. Additionally, the quality of life, pain, and mortality in each patient will be monitored. CivaSheet will reduce the radiation delivered to adjacent mediastinum and therefore should result in fewer side effects. Additionally, it will provide a conformal dose, reduce the risk for infection, and possibly reduce treatment related side effects. CivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense for localized cancer. CivaTech Oncology is committed to making the CivaSheet available to cancer patients in multiple indications.