MedPacto Launches Global Phase 2 Clinical Trial of Vactosertib for Osteosarcoma

MedPacto, an innovative drug development company, announced on September 1 that it will begin a Phase 2 clinical trial of its new drug candidate "Vactosertib" for osteosarcoma patients.

MedPacto is conducting clinical trials in South Korea and the United States for adult and adolescent (ages 12 to 17) osteosarcoma patients. The company recently completed Phase 1 clinical trials for adults and has started recruiting patients for Phase 2. The Phase 1 cohort (patient group) for adolescent patients is also nearing completion, and Phase 2 will begin soon.

With the entry into Phase 2, MedPacto is significantly expanding its clinical sites. In South Korea, trials are currently underway at three hospitals: National Cancer Center, Korea Cancer Center Hospital, and Bundang Seoul National University Hospital. Three additional hospitals will be added: Seoul National University Hospital, Asan Medical Center, and Samsung Medical Center.

A large number of patients eligible to participate in the clinical trials are reportedly already waiting at the newly added sites. MedPacto expects that the clinical trial for "Vactosertib" in osteosarcoma will proceed at an even faster pace.

MedPacto has also received requests for "compassionate use" of "Vactosertib" for osteosarcoma patients from Johns Hopkins University Hospital and Arkansas Children's Research Institute (ACRI) in the United States, and is currently undergoing the relevant approval procedures.

Previously, MedPacto received a total of 10 "compassionate use" requests from overseas medical institutions, including Stanford University Hospital, UCLA Medical Center, Oregon Health & Science University Hospital, and Case Western Reserve University Hospital, and administered the drug to osteosarcoma patients.

A MedPacto representative stated, "As the recent Phase 1 results for Vactosertib in osteosarcoma exceeded expectations, interest from medical professionals at home and abroad is growing. We will accelerate the clinical trial process to obtain early approval and will also actively pursue technology export opportunities."

Osteosarcoma is a malignant tumor that develops in bone and cartilage, and is a rare cancer with a particularly high incidence in children and adolescents. For the past 50 years, combination chemotherapy has been the standard treatment, but there are limitations in improving treatment efficacy and survival rates, leading to high demand for new therapies.

Vactosertib is known to inhibit the TGF-beta signaling pathway, suppress the expression of the oncogene C-Myc in the osteosarcoma microenvironment, and improve the immune environment. In ongoing clinical trials for relapsed or refractory patients, Vactosertib monotherapy has demonstrated a partial response (PR) rate of over 35%.

Vactosertib has already been designated as an orphan drug in the United States and Europe. It has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). MedPacto is additionally in discussions with the FDA regarding Breakthrough Therapy designation for "Vactosertib."

This content was produced with the assistance of AI translation services.