Cell therapy was recently described as “One of the most promising new fields of science and medicine,” by FDA Commissioner Scott Gottlieb. He went on to state that cell therapy and regenerative medicine “…hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.” In the FDA statement issued August 28th, Gottlieb also revealed that the U.S. regulator is looking improve upon its approval process for cell therapies. [Read more…]
- Grant from European Union’s Horizon 2020 program to nTRACK project designed to study nanoparticle effects on PLX-PAD cell viability and functionality
- Grant brings total to approximately $25 Million (€21.8 million) in funding from Horizon 2020 program to cover clinical and research activity for PLX-PAD
HAIFA, Israel, Oct. 02, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that a $7.9 million (€6.8 million) non-dilutive grant from the European Union’s Horizon 2020 program has been awarded to nTRACK, a collaborative project carried out by an international consortium led by LEITAT. [Read more…]
Pluristem’s Ongoing Phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe
Fast Track Designation allows for expedited review of drugs to treat serious conditions with unmet medical need
HAIFA, Israel, Sept. 18, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need,” said Zami Aberman, Chairman and Co-CEO of Pluristem.
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay. [Read more…]
The lifetime prevalence of hip fracture in the U.S. is 10% for men and 20% for women. Incidence is expected to continue to rise, driven by an increasing elderly population. Even with today’s surgical repair techniques and post-operative care, at 6 months postinjury, only half of patients can perform their pre-fracture daily living activities. At 1 year after hip fracture, older adults are five times more likely to be institutionalized than age-matched controls without hip fracture, and mmortality rates resulting from hip fracture range from 12% to 37% within the first year. In parallel, the cost to the U.S. healthcare system is also staggering, and amounts to between $10 and $15 billion annually. [Read more…]