HAIFA, Israel, July 27, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study regarding PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Stem Cells. The paper, titled “Mesenchymal stromal cells prevent allostimulation in vivo and control checkpoints of Th1 priming: migration of human DC to lymph nodes and NK cell activation”, describes the findings of a recent mechanism of action study conducted by independent scientists at the Berlin-Brandenburg Center for Regenerative Therapy at Charite – University Medicine Berlin. The paper was co-authored by scientists from the Charite and Pluristem.

The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated in vitro that MSC, and in particular PLX cells, control the induction of an immune response at several points. The main target for MSC and PLX cells in this process are dendritic cells, which are the key player in inducing a T-cell immune response. Moreover, in vivo data from patients suffering from critical limb ischemia who were treated with PLX cells in a phase I/II study confirmed that HLA-unmatched PLX cells did not provoke an immune response in immunocompetent patients. These findings confirm the feasibility of using PLX cells in an off-the-shelf manner, and explain the mechanisms that make this possible.

“Our findings in this study provide novel evidence for the regulation of several checkpoints of T-cell priming by PLX cells and other MSC, via modulation of the crosstalk between myeloid dendritic cells and natural killer cells. While the complete mechanism of immunomodulation by PLX cells requires further investigation, this study demonstrates how PLX cells might inhibit the immune responses of Type 1 T helper cell,” stated the study’s Principal Investigator, Dr. Hans-Dieter Volk, Director of the Berlin-Brandenburg Center for Regenerative Therapy and head of the Institute of Medical Immunology at the Charite.

“The investigation of the interaction between unmatched PLX cells and patient immune systems is central to Pluristem’s clinical research. This research may lead to a new understanding of how PLX cells influence, and potentially heal, the immune system, thereby possibly expanding the use of PLX cells for new indications,” stated Pluristem CEO Zami Aberman. “By modulating a patient’s immune response, PLX cells could potentially help treat severe diseases of the immune system such as aplastic anemia, which has been designated as an orphan indication, autoimmune diseases such as multiple sclerosis and lupus, as well as graft versus host disease (GVHD),” Aberman added.

GERMANTOWN, MD–(Marketwired – Jul 29, 2015) – Orgenesis Inc. (OTCQB: ORGS), a cell therapy and regenerative medicine company with a novel therapeutic technology dedicated to converting a patient’s own cells into functioning insulin-producing cells as a treatment for diabetes, today announced that its wholly owned subsidiary, MaSTherCell, a Contract Development and Manufacturing Organization (CDMO) has entered into a Memorandum of Understanding with France-based TxCell (TXCL.PA) (Euronext Paris: FR0010127662 – TXCL), to manufacture clinical batches of Ovasave®, TxCell’s lead product. Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of Inflammatory Bowel Disease. As part of the Memorandum of Understanding, MaSTherCell and TxCell also agreed to enter into discussions for the long-term clinical and commercial manufacturing by MaSTherCell of TxCell products.

Ovasave batches manufactured by MaSTherCell will be used by TxCell in its ongoing Phase 2b trial, CATS29, for the treatment of Crohn’s disease. The first clinical batches could be manufactured by MaSTherCell as soon as Q2 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel groups study. The trial has been designed to include 160 severe refractory Crohn’s disease patients. It is currently on-going in 30 study sites in 6 countries including Austria, Belgium, France, Germany, Italy, the United Kingdom, and may be extended into the U.S. The United States Food and Drug Administration recently granted Fast Track Designation to Ovasave for the treatment of moderate to severe Crohn’s disease.

“MaSTherCell is a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials. This strategic relationship with MaSTherCell is very important to TxCell,” said Stéphane Boissel, Chief Executive Officer of TxCell.

Vered Caplan, Chairperson and CEO of Orgenesis, commented, “We are pleased that MaSTherCell has entered into a substantial cell manufacturing agreement with TxCell for Ovasave, in an indication that has a clear unmet need which may best be treated through a cutting edge cell therapy like Ovasave. We look forward to working very closely with TxCell to deliver unparalleled manufacturing services for its trial.”

PETACH TIKVA, Israel, July 29, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced that the World Health Organization’s International Nonproprietary Name group has accepted the proposed generic name “piclidenoson” for its lead drug candidate, CF101.

“We are pleased that the World Health Organization recognized the very unique pharmacological nature of CF101 and has granted it a new generic name,” stated Can-Fite CEO Dr. Pnina Fishman. “This is a very important step towards bringing a new drug to market and comes at an important time for Can-Fite as we prepare to enter advanced stage clinical trials for CF101 in rheumatoid arthritis and psoriasis.”

International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system’s aim is to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.