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Genexine Enters into Clinical Trial for Thyroid-Stimulating Hormone (TSH), Orphan Disease Treatment
Genexine Inc. (KOSDAQ:095700), a clinical stage biotechnology company developing innovative biologics focused on orphan diseases and immuno-oncology, announced that an IND approval of GX-30, recombinant Thyroid-Stimulating Hormone (TSH), was granted a trial of Phase I & II from the Ministry of Food and Drug Safety (MFDS).
For thyroid cancer patients, surgery is performed to remove the thyroid gland in Korea. However, surgery does not usually remove 100% of the thyroid tissue from the patient’s affected part and which can cause recurrence or metastasis of cancer. GX-30 helps to ablate the remnant as well as diagnose for the recurrence and metastasis of thyroid cancer.
Phase I clinical trial is scheduled to initiate in the second half of 2017 with the well-differentiated thyroid cancer patients who have previously undergone thyroidectomy. Phase I trial will evaluate PK, PD, and safety data in the target patients and Phase II will conduct to see efficacy data after completing Phase I.
Genexine representative said, “We expect to shorten the overall clinical trial period since Phase I & II INDs were approved at the same time and also expect to receive conditional sales approval after completing Phase II. GX-30 will lighten the burden of patients and clinical institutions through realizing the competitive drug price based on the optimal manufacturing system.
▶ About Genexine:
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on orphan diseases and immuno-oncology. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric growth hormone deficiencies, currently in multinational phase II trials after the completion of an EU Phase I study. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III, and plans to enter into Phase 1b/2a trial in cervical cancer with GX-188E in combination Keytruda (anti- PD-1 therapy) of Merck (also known as MSD) in mid-2017. Founded in 1999, Genexine has over 150 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.