Pluristem Submits Pre-IND Application in Germany to Initiate Clinical Trials of PLX-PAD for Peripheral Artery Disease
BUSINESS WIRE
Posted: 2008-03-04 08:22:01
NEW YORK--(BUSINESS WIRE)----Pluristem Therapeutics, Inc. (NASDAQ:PSTI) announced today that it has filed a Pre-Investigational New Drug (Pre-IND) application with the Paul Ehrlich Institute (PEI) in Germany for PLX-PAD, the Company's product for the treatment of Peripheral Artery Disease. The PEI is the German federal authority granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX(TM) technology.
Pluristem has submitted a scientific package to the PEI. The package contains the results of a proof of concept study and preclinical study synopses utilizing PLX-PAD to support an IMPD (Investigational Medicinal Product Dossier) submission planned for later this year. This Pre-IND document also contains information concerning the process used to manufacture Pluristem's PLX-PAD product and the proposed clinical trial supporting the Company's IMPD.
Zami Aberman, Pluristem's President & CEO, stated: "I am proud that our team has accomplished this important milestone in submitting this Pre-IND document as planned. I believe it represents the Pluristem team's ability and devotion to successfully meet the Company's goal of building a pipeline of PLX products, leading the Company to future achievements and prosperity."
About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from the human placenta, a non-controversial source, and not from embryonic stem cells.
The placental cells are expanded in the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors, or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent, and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to their secretion of cytokines or other potent immune modulators. Furthermore, the PLX cells are immune-privileged and immunosuppressive, hence protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's PLX-PAD is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). Pluristem has previously announced its PLX cells can be therapeutically beneficial in the treatment of a variety of other indications, such as ischemic stroke and Parkinson's disease (PD).
The Company's PLX-I is intended to resolve the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood (UCB).
Pluristem has offices in the USA with research and manufacturing facilities in Israel. |
