Oncos Therapeutics announced that the FDA has granted Orphan Drug Designation to CGTG-102, a granulocyte-macrophage colony stimulating factor-coding oncolytic adenovirus (Ad5/3-D24-GMCSF) for the treatment of soft tissue sarcoma.
CGTG-102, is an oncolytic immunotherapy based on a modified, GM-CSF encoding adenovirus that selectively replicates in tumor cells and eventually kills them. Upon tumor cell death, newly synthesized viruses are released and infect neighboring tumor cells. At the same time, tumor antigens are exposed activating a tumor specific, systemic response by the patient’s immune system. This response is further enhanced by the CGTG-102 induced production of GM-CSF in tumor cells.
A Phase 1 study with CGTG-102 will be completed this year and Phase 2 studies are scheduled to start in 2014.
For more information visit www.oncos.com.