PV-10 (small molecule oncolytic immunotherapy) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a non-central nervous system pediatric solid tumor. Intratumoral injection of PV-10 has been demonstrated to cause immunogenic cell death in solid tumor cancers. It is also associated with causing stimulation of tumor-specific reactivity in circulating T cells.
Neuroblastoma is a cancer that develops from immature nerve cells and usually begins in the adrenal glands. It may also begin in the chest, abdomen, or near the spine. Most often, it affects children younger than 5 years of age, and as per the estimates released in 2015, the 5-year survival among children 0 to 19 years of age is 75.2%. PV-10 was previously granted Orphan Drug designation for the treatments of metastatic melanoma in 2007 and hepatocellular carcinoma (HCC) in 2013.
Provectus’ flag-bearer investigational oncology drug, PV-10, is reputed to be the first small molecule oncolytic immunotherapy agent which can induce immunogenic cell death. At present, it is undergoing clinical study for melanoma and cancers of the liver, and preclinical study is being done for pediatric cancers.
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