Pluristem said today it won approval for a grant of NIS 12 million (about $3.3 million) from Israel’s Office of the Chief Scientist (OCS) to cover R&D expenses for 2013.
Under the terms of the grant, Pluristem is required to pay royalties of 3–5% on sales of products and services derived from technology developed using this and other OCS grants, until 100% of the dollar-linked grant amount plus interest are repaid. No payment is required, however, in the absence of such sales.
“This grant helps us to further advance our R&D pipeline and to move new indications into our growing product portfolio clinical trials in the United States, Israel, and Europe,” Zami Aberman, Pluristem’s chairman and CEO, said in a statement.
Pluristem is the developer of the PLX (PLacental eXpanded) cells drug delivery platform, which helps treat local and systemic inflammatory diseases through release of a cocktail of therapeutic proteins.
Pluristem’s PLX cells are mesenchymal-like adherent stromal cells (ASCs) derived from full-term human placentas, and expanded in the company’s bioreactor system to create a three-dimensional (3D) microenvironment allowing for the controlled, large-scale growth of cells at a fraction of the cost of traditionally expanding cells using petri dishes or tissue flasks. The 3D expansion technology, which entails bar coding the cells, also allows Pluristem to product specific PLX cell products for each targeted indication.
In January, Pluristem opened a manufacturing facility capable of producing up to 150,000 doses annually of the PLX cells, which require no tissue matching or immune-suppression treatment before administration. “This allows Pluristem to support a variety of clinical trials and, if and when PLX product candidates are approved for marketing, to supply PLX products to its partners,” Aberman said in the statement.
Data from two Phase I clinical trials indicated that Pluristem’s first PLX product, PLX-PAD, demonstrated safety and potential effectiveness in treating end-stage peripheral artery disease. Pluristem’s pre-clinical animal models had previously shown PLX cells were potentially effective in nerve pain and muscle damage when administered locally, and in inflammatory bowel disease, multiple sclerosis, and stroke when administered systemically.