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FDA, EMA grant orphan drug status to CGTG-102 for soft tissue sarcoma
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The FDA and the European Medicines Agency have granted orphan drug designation for CGTG-102, a granulocyte-macrophage colony–stimulating factor-coding oncolytic adenovirus for the treatment of soft tissue sarcoma.
CGTG-102 (Oncos Therapeutics) originates from a modified GM-CSF-encoding adenovirus that selectively replicates in, and eventually eradicates, tumor cells. Upon tumor cell loss, newly synthesized viruses are then released to infect adjacent tumor cells.
Concurrently, tumor antigens are exposed, stimulating a tumor-specific systemic response by the patient’s immune system, which further enhances the CGTG-102-induced production of GM-CSF in tumor cells.
“We are pleased to receive orphan drug designations for CGTG-102 from the two leading regulatory agencies in the world. These designations confirm the need for developing novel therapies for rare cancers and are an important step in the development of CGTG-102,” Frans Wuite, MD, president and CEO of Oncos Therapeutics, said in a press release.
A phase 1 study with CGTG-102 is expected to conclude this year, with phase 2 studies scheduled to begin in 2014.
Before the phase 1 study, 115 patients with chemotherapy refractory solid tumors had been treated with CGTG-102 in an individualized treatment program regulated by the Finnish Medicines Agency as determined by the European Union Regulation on Advanced Therapy Medicinal Products, EC/1394/2007.