|Pluristem Awarded Grant from Israel’s Ministry of Economy for Marketing its PLX Cell Therapy in Japan|
|Wednesday, 03 June 2015 19:22|
HAIFA, ISRAEL--Pluristem Therapeutics Inc. (NasdaqCM: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has been awarded a Smart Money grant from Israel’s Ministry of Economy.
The program’s aim is to assist companies to extend their activities in international markets. The Israeli government will grant Pluristem budget and resources for the marketing of its advanced cell therapy products in Japan and for regulatory activities there. Pluristem will also receive assistance from Israel’s trade attachés stationed in Japan, and from experts appointed especially by the "Smart Money" program. In this first round of the program seventy-nine requests were submitted, of which thirty-nine were approved.
Pluristem recently announced that Japan’s Pharmaceuticals and Medical Devices Agency agreed to the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This is an important prerequisite for initiation of a Phase I/II study in critical limb ischemia via Japan’s Accelerated Pathway for Regenerative Medicine. The new regulatory pathway can significantly reduce time to market for regenerative therapies such as PLX cells.
“We are pleased to receive the support of the Israeli government in our efforts to bring our cell therapy products to Japan. In recent years the governments of Israel and Japan have increased cooperation on many fronts including investment and trade. We are targeting the Japanese market and expect to be one of the first to launch an allogeneic cell therapy there via Japan’s Accelerated Pathway for Regenerative Medicine regulation,” stated Pluristem Chairman and CEO Zami Aberman.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the potential of the Japan’s Accelerated Pathway for Regenerative Medicine regulation to significantly reduce time to market our regenerative therapies and when we discuss our expectation to be one of the first to launch an allogeneic cell therapy in Japan via such new regulatory pathway. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.