July 7, 2016 — Cell>Point announced in mid-June it has entered into an exclusive license agreement for China, Hong Kong and Macau with United Eastern Pharmaceutical (UEP), a company representing a consortium from the United States and China. The license agreement covers Cell>Point’s diagnostic radiopharmaceutical Oncardia (ethylenedicysteine-glucosamine) which was developed for labeling with technetium-99m for single photon emission computed tomography (SPECT) cameras or 68-gallium for positron emission tomography (PET) cameras for imaging in cancer and cardiovascular disease.
Oncardia is based on an ethylenedicysteine drug conjugate platform licensed by Cell>Point from The University of Texas MD Anderson Cancer Center. The license with UEP provides for Cell>Point to receive an upfront payment and regulatory milestone payments as well as royalties on sales. Cell>Point will be seeking regulatory approval from the China Food and Drug Administration (FDA) to expand its Phase 3 lung cancer imaging trial to include clinical sites in China. The parties have agreed that when the current cardiovascular study reaches Phase 3, Cell>Point will include China clinical sites as part of the study.
According to Haoran Xi, CEO of UEP, “China needs affordable and accessible diagnostic molecular imaging to reach a substantially larger universe of people than is presently the case with the current standard of care. Plans are to pursue approvals in diagnosing and staging lung, head and neck, colorectal, breast, liver, stomach, lymphoma and other cancers in addition to diagnosing the presence and extent of cardiac ischemia. Oncardia can be used to assess the patient’s response to therapy while undergoing therapy. This will give oncologists a valuable tool to determine if the patient is benefiting from the selected therapy or should the oncologist reconsider the choice of therapy. The Chinese Central Government is implementing programs to improve the quality of medical care throughout the country. Cancer and vascular disease are the leading causes of death in China.”
Oncardia was developed to address the limitations of FDG-PET (positron emission tomography) in cancer imaging while increasing access to cancer imaging to a significantly greater number of hospitals worldwide. Cell>Point is completing a Phase 3 trial for Oncardia in lung cancer under a Letter of Agreement with the FDA pursuant to a Special Protocol Assessment, and a Phase 2b cardiovascular trial in patients with coronary artery disease. The focus in cardiology is to assess the patient’s ischemia in a rest-only imaging procedure which will dramatically shorten the time required to complete the patient’s study and achieve noticeably greater diagnostic accuracy compared to the standard of care.
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