PharmAbcine, a developer of antibody drugs, said it has registered the first patient for a global phase-2 clinical trial on olinvacimab (TTAC-0001).
In the U.S. and Australia, the phase-2 study will administer the investigational drug in incremental doses of 16, 20, and 24mg/kg to 23 patients with recurrent glioblastoma who do not respond to Avastin. The primary assessment will be monitoring the drug’s safety indicators during the treatment, and the second phase will assess the responsiveness to the drug to observe changes in brain tumor size.
The study will also check for changes in the quality of life (QoL) by gauging changes in cerebral edema size and steroid use.
Glioblastoma is a type of brain tumor that accounts for 15 percent of all brain tumors. The first-line therapies are surgery, medication, and radiation therapy, but most glioblastoma relapse within one year. Five-year survival is less than 3 percent. The standard treatment for recurrent glioblastoma is Roche's Avastin.
PharmAbcine expects that olinvacimab, like Avastin, can be used to prevent tumor growth and metastasis by preventing neovascularization of tumors. Olinvacimab not only inhibits tumor neovascularization of VEGF-A (Vascular Endothelial Growth Factor-A) but that of VEGF-C and VEGF-D, which could be an alternative for patients who do not respond to Avastin, the company said.
“There is no appropriate treatment for glioblastoma, which causes a swelling in the brain and extreme pain for the patient,” an official at PharmAbcine said. “We will aggressively target diseases without an alternate treatment to demonstrate the value of olinvacimab and expand indications to various types of cancer.”
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