In March 2018, Cellular Bi (NASDAQ:CBMG) announced results from the Phase I study of AlloJoin for knee osteoarthritis (KOA). The primary endpoint was safety, and the adverse event (AE) profile was similar to previous studies, with pain and swelling as the primary effects. The company did not release detailed efficacy data, but it appears that the treatment effect was sustained for 48 weeks, and it appeared to stop cartilage degradation.
AlloJoin safe, but not without pain
The safety data from the Phase I trial did not show any serious adverse events (SAEs), or any AEs that would preclude the use of the treatment such as inflammatory reactions or neoplasias. However, half of the patients examined in the study had grade 3 pain (no grade 4 events were observed) and two patients did not complete the study due to pain. The pain remitted after treatment in five to 14 days, although efficacy will have to be sufficient to justify this patient hurdle.
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