Oncology Drug PV-10 Gets Orphan Drug Status for Ocular Melanoma

Intratumoral Injection Stimulates Immune Activation

Provectus’ small-molecule oncolytic immunotherapy PV-10 has received an orphan drug designation for the treatment of ocular melanoma, including all melanoma disease affecting the eye and orbit. Intratumoral injection of PV-10 stimulates tumor-specific immune activation via immunogenic cell death in solid tumor cancers.

Ocular melanoma is a rare disorder and is estimated to be diagnosed in around 2,500 people in the U.S. each year. Uveal melanoma, the most common form, originates in melanocytes in the iris, ciliary body, or choroid.

Along with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of patients with ocular melanoma develop metastatic disease, which is typically fatal, regardless of successful treatment of their primary tumors.

Preliminary data from a phase 1 "basket study" of PV-10 for the treatment of cancers metastatic to the liver indicated that treatment-related adverse events were consistent with established patterns; and reduction of tumors reduction was observed in five out of six tumors injected with PV-10.

PV-10 is currently undergoing clinical study for adult solid tumor cancers, such as melanoma and liver cancers, as well as preclinical study for pediatric cancers.

Source: Provectus, February 12, 2019