Advanced Cell Technology, Inc. (ACT) a leader in the field of regenerative medicine, announced that China’s State Intellectual Property Office (SIPO) has allowed the company’s patent application to provide broad intellectual property protection in China for the manufacturing and pharmaceutical preparations of Retinal Pigment Epithelial (RPE) cells from human Embryonic Stem Cells (hESCs).
This Chinese patent filing provides coverage of the scalable manufacturing of human RPE cells from hESCs. The claims cover methods for producing purified preparations of RPE cells from hESCs, and the use of those hESC-derived RPE cells in pharmaceutical preparations and compositions.
“The fact that we are being awarded a set of broad claims in China, following the issuance of the three far-reaching RPE patents in the US last year, gives us greater confidence that we are in a position to create a dominant patent position around our stem cell-derived RPE programme in leading markets around the world,” said Gary Rabin, ACT’s interim chairman and CEO. “Our progress in obtaining patent protection in China for our RPE programme is a testament to the continued recognition of the inventions and innovations resulting from our scientific team’s ongoing research, and further protects the platform technology underlying one of our key therapeutic programmes.”
The efficient production of highly pure RPE cell preparations derived from human embryonic stem cells represents the first critical step in the creation of a renewable source of transplantable cells that can be used to target macular degenerative diseases such as Stargardt’s Macular Dystrophy (SMD) and Dry Age-related Macular Degeneration (Dry AMD). The company has already demonstrated that its hESC-derived RPE cells can rescue visual function in animal models of macular degeneration. At the end of 2010, ACT received clearance from the United States Food and Drug Administration (FDA) for two of its Investigational New Drug (IND) applications to initiate multi-centre clinical trials using hESC-derived RPE cells to treat patients with SMD in one case (a common form of juvenile macular degeneration) and to treat Dry AMD in the other. The claims allowed by SIPO are similar to those the company received as part of US Patent Number 7736896, issued last June.
“This IP issuance is a particularly valuable step forward for us in Asia, as it could facilitate partnering and licensing arrangements,” added Rabin. “China is predicted to become the third-largest pharmaceutical market in the world later this year, and is an essential part of our global strategy. This patent allowance is an indicator of what we hope to achieve in the IP realm in Europe and elsewhere.”
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine.