바이오스펙테이터

바이오스펙테이터 Jongwon jang 기자

▲김권 셀비온 대표.

Cellbion, a radiopharmaceuticals development company, has started their development of diagnostic and therapeutic radiopharmaceuticals. In particular, the company’s goal is to develop ‘Theranosis’, a radiopharmaceutical that can be used simultaneously for both diagnostic and therapeutic purposes.

Mr. Kim Kweon, the president and CEO of Cellbion, explained that “radiopharmaceuticals can be applied in various situations, and at the same time provide a very simple and clear method to assess their effectiveness; this will bring high future values to radiopharmaceuticals.”

Cellbion’s current R&D projects are: radiopharmaceutical for cardio & cerebrovascular imaging diagnosis (Ga-68-NOTA-MSA); multifunctional contrast medium for surgery; and diagnostic and therapeutic pharmaceutical targeting prostate cancer. The company is now at the stage of Phase 2 clinical trial for radiopharmaceutical for cardio & cerebrovascular imaging diagnosis; the multifunctional contrast medium for surgery obtained approval in Korea for Phase 1 clinical trial in August this year.

Ga-68-NOTA-MSA, developed on HAS, effectively diagnoses atherosclerosis, which is known as a direct cause of cardiovascular diseases. Mr. Kim emphasized that it is “a first-in-class drug, the only contrast medium for PET that can diagnose atherosclerosis.” The product is proven for its safety and effectiveness in Phase 1 Clinical Trial, and is now undergoing Phase 2 clinical trial in Korea, and overseas clinical trial.

Cellbion obtained approval from the Ministry of Food and Drug Safety in Korea for its Phase 1 clinical trial of Tc-99m-MSA-ICG, a contrast medium for Fluorescent image guided surgery done on cancer patients. The clinical trial will be conducted with 12 patients at Seoul National University Hospital, in order to evaluate the product’s safety, drug tolerance, and effective dose.

Cellbion has discovered a new compound, NOTA-SCN-GUL, which targets Prostate specific membrane antigen (PSMA), and is currently developing a diagnostic pharmaceutical product PSMA-GUL-NOTA. Mr. Kim said “When the diagnostic drug that uses Ga-68 isotope was injected through the vein of mouse tail in the animal test, we found cancer marked on the image within one hour”, and continued, “The test confirmed that more than 90 % marking on cancer is possible”.

The company is also in the process of developing a diagnostic, and at the same time therapeutic pharmaceutical for prostate cancer patients. In 2016, researchers at Heidelberg University Hospital attracted great attention when they published the result of their clinical research on the application of PSMA target therapy with Lu-177 on prostate cancer patients in the Journal of Nuclear Medicine.

Mr. Kim added, “Animal testing conducted during the preclinical study has already proven the pharmaceutical’s outstanding performance in reducing masses”, and emphasized that the company “will invest great effort to complete the development soon, and enter into the market, as global competition is fierce in the field.”

“As the importance of precision medicine grows more and more, bioimaging, which enables real-time monitoring, diagnosis, and treatment, is also becoming more important. Cellbion will put much effort into becoming a global leader by developing and producing Theranosis, an innovative new drug that is at the center of attention”, said Mr. Kim.

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