“Navigation Drug (ND)” a platform technology visualizing specific target 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. We already develop one clinical trial (GCP-002 for esophageal cancer detection) and two preclinical trial (GCP-003 for pancreatic fistula detection; and GCP-005 for glaucoma detection) in vivo NDs.
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. In case of digestive organs surgery, the ND could visualize auxiliary risk factors such as pancreatic fistula and improve the operational productivity.
The GCP-002 is going to achieve clinical Proof of Concept promptly. We seek out-licensing or co-developing partners regarding the ND as well as fluorescent detection devices for use with the ND.
TECHNOLOGY FEATURES & SPECIFICATIONS
The ND is designed to start emitting fluorescence through chemical reactions on receptive substance of the target materials but shows almost no fluorescence before the reactions. The activated ND’s strong luminescence provides clear fluorescence recognition 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-002 emits fluorescence through dipeptidyl peptidase-Ⅳ (DPP-Ⅳ) enzymatic reaction and accumulates in cancer cell. Since DPP-Ⅳ expression and the enzymatic activity are rich in esophageal cancer cell membrane, the GCP-002 is under investigation of the safety in clinical trials for the indication of endoscopic surgery and is in the process of trying to achieve the clinical POC.
The isolating reaction of HMRG completes and the strong fluorescence becomes active within several minutes after spraying the ND on the target materials. 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: Esophageal cancer detection; Pancreatic fistula detection; and Glaucoma detection.
Other applicable areas: Colorectal cancer detection; Liver cancer detection; Ovarian cancer detection; Pharyngeal cancer detection; Barrett's esophageal cancer detection; Brain tumor detection; Lung cancer detection; and Gastric cancer detection.
Developable products: Real time pathological diagnosis agent for surgical operation or medical checkup; Auxiliary risk factor visualization agent for surgical operation; and Photodynamic therapy agent.
Estimated size of the market: over two billion US dollars of peak sealings on a basis of global patients numbers.