COPENHAGEN — A novel agent derived from human umbilical tissue and a novel system to deliver the agent suprachoroidally may ultimately benefit patients with retinal disease, according to Christopher Riemann, MD.
Riemann explained both the agent and the delivery system at the Euretina meeting.
The agent, palucorcel, is an allogenic human umbilical tissue-derived nondividing cell line that has a trophic effect.
“Basically it’s umbilical cells that secrete a secret sauce of cytokines that we think can be beneficial for the treatment of retinal disease,” Riemann said.
Palucorcel was well tolerated after subretinal delivery with no immune rejection in a phase 1a trial in seven patients with advanced retinitis pigmentosa, although retinal detachment occurred in two patients. In a phase 1/2a trial in 33 patients with geographic atrophy, the drug was similarly well tolerated with no immune rejection, but the retinal detachment rate was 15% and the surgical complication rate was higher than that, Riemann said.
“Nonetheless, despite suboptimal surgical outcomes, 25% of patients gained three ETDRS lines, 15 letters, and 50% gained two lines, or 10 letters. So we recognize the surgical challenge. For the cell therapy to work, the cell therapy needs to be close to the target cells for the cytokines to be able to have a treatment effect. And because of this issue with retinal detachment and membrane formation, a non-retinal penetrating delivery was required to prevent the cells from escaping into the vitreous cavity,” Riemann said.
The delivery system that was devised to achieve this end incorporates a suprachoroidal approach, in which a peripheral sclerotomy is developed, a cannula is advanced in the suprachoroidal space to the target area, and a needle is advanced through the choroid into the subretinal space for delivery of the palucorcel cells.
A phase 2b study is ongoing; 21 patients thus far have undergone cell delivery with the new procedure. – by Patricia Nale, ELS
Riemann C. Development of a novel subretinal delivery procedure using a suprachoroidal approach. Presented at: 16th Euretina Congress; Sept. 8-11, 2016; Copenhagen, Denmark.
Disclosure: Riemann reports he is a consultant for Janssen and Kaleidoscope Engineering.