“Ex-vivo Navigation Drug” – Active Visualization for Extracorporeal Surgical Operation


Healthcare - Diagnostics


“Navigation Drug (ND)" is a platform technology visualizing specific target biophysical materials including cancer cells, secretions and molecules intracorporeally (in vivo) and/or extracorporeally (ex vivo) on a basis of site specific active and strong luminescence fluorescent probes. Although conventional probes emit fluorescence regardless of the presence or absence of the target materials, the ND is designed to start emitting fluorescence through chemical reactions on receptive substance of the target materials. The strong luminescence of the ND provides clear fluorescence recognition. The ND technology has great potential to cover any indication of diagnosis and surgical treatment on a basis of detecting the specific target biophysical materials. In case of cancer surgery, the ND not only decreases cancer cells remaining and improves patient’s Quality of Life as a consequence of accelerating discernment between cancer and normal cells through surgery, but also make the total surgical time shortened and improve the operational productivity as a consequence of providing real time pathological diagnosis to operation teams. One clinical trial (GCP-001 for breast cancer detection) ex vivo ND is completed and currently pending marketing approval. Since the provider is going to have a sales alliance regarding the ex vivo ND in JP, they seek out-licensing partners in the other regions.


The ND is designed to start emitting fluorescence through chemical reactions on receptive substance of the target materials and activated ND’s strong luminescence provides clear fluorescence recognition even with white lights of the surgical operation room due to the usage of specific fluorophore and chemical linkage technology. The strong fluorescence of the fluorophore “hydroxymethyl rhodamine green (HMRG)” is quenched by the covalently bound ligand structure for the target enzyme, but the HMRG is quickly isolated after reacting with the target enzyme overexpressed on the target cells or tissues such as cancer cells or the target substance. Since the HMRG is able to accumulate in the target cells or tissues due to its cell membrane permeability, the target cells or tissues can be visualized via fluorescence imaging easily and specifically. More specifically, the GCP-001 emits fluorescence through gamma-glutamyl transferase (GGT) enzymatic reaction and accumulates in cancer cell lysosomes. Since GGT is abundantly expressed in breast cancer cell membranes, the GCP-001 is being investigated in the clinical trial to visualize breast cancer cells in breast tissue removed during surgery, and is about to obtain the marketing approval. The isolating reaction of HMRG completes and the strong fluorescence becomes active within several minutes after applying the ND on the excised breast tissue. Therefore, the surgical operation team members can perform the operation safely and accurately with real-time pathological diagnosis, and the visibility of the residual cancer contribute to reduce the risk that the cancer regions will remain unresected.


Primary application areas: Breast cancer detection. Other applicable areas: Any cancer indication that requires quick time pathological diagnosis on excised tissue. Developable products: Quick time pathological diagnosis agent for surgical operation or medical checkup. Estimated size of the market: over fifteen million US dollars of peak sealings on a basis of global patients numbers even if limited on the breast cancer detection.
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