MedPacto receives IND approval from FDA to evaluate the safety and efficacy of Vactosertib as a single agent in patients with osteosarcoma
Aug 19, 2022
A phase 1/2 clinical trial for adolescents under the age of 14 and adults with recurrent, refractory, or progressive osteosarcoma
On August 5th, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s investigational new drug (IND) application for its Vactosertib as a single agent in patients with recurrent, refractory or progressive osteosarcoma.
Case Western Reserve University School of Medicine, UH Rainbow Babies and Children's Hospital is designated as one of the clinical trial institutions. It is an upcoming global and multicenter clinical trial, a phase 1/2 study to assess the safety, tolerability, pharmacokinetics, and antitumor activity of Vactosertib as a single agent in a total of 54 patients including adolescents (ages 14-18) and adults with recurrent, refractory or progressive osteosarcoma.
Osteosarcoma, a malignant osseous neoplasm that usually develops in connective tissue, such as bone, cartilage, or muscle, is one of the most commonly reported rare cancers that accounts for 5.6% of sarcoma cancer. It can develop at any age, but most cases occur during childhood, early adolescence, and young adulthood, and among the reported cases, 25~50% experience lung metastasis even during chemotherapy.
Osteosarcoma treatment typically involves surgery, chemotherapy, and radiation therapy. Surgeries in parallel with chemotherapy make up roughly 45.5% of all total treatments while drug treatment makes up only 15.9%, hence there is a growing need for new treatment options.
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.
“This upcoming clinical trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of Vactosertib as a single agent in adolescents and adults with recurrent, refractory or progressive osteosarcoma.”, “The clinical result will have us move one step forward to the early sale market entry” stated a MedPacto representative.