MedPacto announced Monday that it received green light from the U.S. FDA to test Vactosertib as a solo therapy for recurrent and intractable osteosarcoma patients in a phase 1/2 trial.

The study will be on 54 patients aged 14 or older who suffer from recurrent or intractable osteosarcoma and carried out at the Case Western Reserve University School of Medicine and UH Rainbow Babies and Children's Hospital.

The company said it plans to evaluate the safety, drug tolerance, pharmacokinetics, and anti-cancer effect of Vactosertib as a sole agent. The company may assess the drug on a larger patient group, depending on interim results.

Osteosarcoma is a malignant tumor that occurs on bones or on osteoid tissue such as the cartilage around the bone. It is rare cancer accounting for 5.6 percent of sarcoma.

Currently, surgery combined with chemotherapy takes up 45.5 percent of osteosarcoma treatment, and drug treatment, only 15.9 percent.

There is a growing demand for new treatment because immunotherapy is considered ineffective and chemotherapy is processed in an old-fashioned way.

In a preclinical trial, Vactosertib significantly reduced osteosarcoma cancer cell growth and pulmonary transfer, improving the survival rate of a mouse by 100 percent and also restraining lung metastasis by 100 percent, according to the company.