Sinopharm has signed a Memorandum of Understanding to in-license PV-10 (10% rose bengal, intralesional) from Provectus Biopharmaceuticals (NYSE: PVCT). They will seek to reach a final license agreement containing upfront, milestone and royalties in the next three months.
Rose bengal disodium (CAS NO: 632-69-9) is a water-soluble xanthene dye. The high-dose formulation (PV-10) and low-dose formulation (PH-10) are developed for the treatment of cancers (melanoma, liver cancer, and breast cancer) and psoriasis/atopic dermatitis, respectively.
Provectus has completed a single arm, 80-patient phase II study in metastatic melanoma (stage III or IV). 25% of patients achieved complete remission, 26% achieved partial remission. Stage III subjects experienced a higher response rate (60% vs 22%), a longer progression-free survival (9.7+ vs 3.1 months), and a longer overall survival (12.6+ vs 7.3 months) than Stage IV subjects.
Based on the phase II results, Provectus submitted a Breakthrough Therapy Designation application to the FDA in March 2014. Not unexpectedly, the FDA rejected this application, because the phase II data were insufficient to demonstrate substantial improvement over existing therapies.
PV-10’s journey to China was not easy. In April 2014, Provectus signed an advisory agreement with Tririver Capital to seek potential partners in China. Finally, they set their eyes on Sinopharm, the largest pharmaceutical company in China. Have you ever seen a biotech company selling its candidate product door to door?
Several years later, the melanoma market will be flooded with immunotherapies such as anti-CTLA4, anti-PD1, and anti-PDL1 mAbs. Would you believe such an intralesional injection without defined mechanism of action to work better than systematic immunotherapies? Provectus stock tells the truth.