- 21st Century Cures Act is designed to speed up drug development by accelerating the regulatory approval process
- Pluristem’s program for CLI is already developed via rapid pathways in both Europe and Japan, where legislation similar to the 21st Century Cures Act has already been passed
HAIFA, Israel, Dec. 18, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, welcomes the approval of U.S. Congress and President Obama of the 21st Century Cures Act, designed to accelerate the discovery, development, and delivery of 21st century cures. Pluristem believes its cell therapies will meet the criteria outlined by the Act as advanced regenerative therapies that can treat a wide range of disease.
The bill puts the U.S. on the same playing field as many other developed countries including those in the European Union (EU) and Japan, which already have accelerated regulatory pathways for regenerative therapies. In Feb 2016, the CFDA has also released a notice saying it would give fast-track status to innovative products that fill the gap of unmet medical needs in the country. Pluristem’s strategy of pursuing accelerated pathways to market around the globe advances with a clinical program for CLI that is already being developed via both Europe’s Adaptive Pathways project and the Japanese PMDA under the new legislation for conditional marketing authorization for regenerative therapies.
“The 21st Century Cures Act is an extremely significant healthcare legislation that may have a direct and beneficial impact on Pluristem’s clinical development programs and progress towards approval for our cell therapies,” stated Pluristem CEO Zami Aberman. “Pluristem has a robust portfolio of cell therapies that are designed to treat severe diseases where there is a high unmet medical need. The accelerated regulatory pathways for regenerative therapies around the globe should allow for early patient access to cell therapies, while also creating medical and economic benefits for the healthcare systems.”
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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