Pluristem Therapeutics, Inc.NASDAQ
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- Thinly traded nano cap Pluristem Therapeutics (NASDAQ:PSTI) is up 11% premarket on light volume in response to its announcement of preclinical data that suggest its PLX-PAD cells may be effective in treating Duchenne muscular dystrophy.
- In a mouse model study, PLX-PAD cells reduced an enzyme called creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by ~50% compared to placebo. In addition, analyses of tissue samples showed reduced levels of inflammation and necrosis (death of most of the cells in an organ or tissue) and evidence of regeneration of muscle tissue.
- PLX cells are mesenchymal-like adherent stromal cells derived from full term human placentas that may be administered without the need for HLA matching. According to the company, PLX-PAD (peripheral artery disease) cells have demonstrated the ability to stimulate the growth of new blood vessels in preclinical models inducing muscle tissue regeneration and improving muscle function.
- PLX-PAD is currently under development for the treatment of critical limb ischemia, intermittent claudication (leg cramps caused by the obstruction of arteries), muscle injury, pulmonary arterial hypertension and preeclampsia.
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Wed, Feb. 17, 1:22 PM
- Micro cap Pluristem Therapeutics (PSTI +27.4%) is up again today on a 3x surge in volume, adding to yesterday's 31% jump. Money flow has spiked in response to the news that NIH's National Institute of Allergy and Infectious Diseases (NIAID) will initiate studies in large animals to assess the company's PLX-R18 cell therapy as a medical countermeasure for the treatment of the hematologic aspects of acute radiation syndrome (ARS).
- Once the optimal dose is identified in large animals, a pivotal trial can be conducted which could support a Biologics License Application (BLA) under the Animal Rule approval pathway. Last September, the FDA confirmed that data from earlier NIAID trials were sufficient for the future design of PLX-R18 studies.
- The Animal Rule is an approval pathway for products that cannot meet the requirements for traditional licensure because efficacy studies in humans are not possible.
- Previously: Pluristem details development plan for second cell product (March 24, 2015)
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Dec. 31, 2015, 8:05 AM
- The FDA designates Pluristem Therapeutics' (NASDAQ:PSTI) lead product candidate PLX-PAD cells an Orphan Drug for the treatment of women with severe preeclampsia, a common complication of pregnancy characterized by high blood pressure and signs of organ damage, often the kidneys. The standard-of-care intervention is delivery since there are no approved medicines for the condition. It is the leading cause of premature births, still births and neonatal and maternal deaths. Severe preeclampsia occurs in ~1% of pregnancies in Western countries.
- In preclinical animal model studies, PLX-PAD cells improved several parameters of the condition, including a reduction in systolic blood pressure, reduction in urinary protein excretion, increase in endothelial function and reduction of spleen weight. Data from an ongoing animal study to confirm the efficacy of PLX-PAD cells in an additional therapeutic pathway are expected in H1 2016.
- PLX cells are mesenchymal-like adherent stromal cells derived from full term human placentas.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Dec. 14, 2015, 9:21 AM
Dec. 8, 2015, 10:12 AM
- Pluristem Therapeutics (PSTI +0.3%) announces that it has received notice from United Therapeutics (UTHR +1.9%) that it is terminating its license agreement for cell therapy PLX-PAD for the treatment of pulmonary arterial hypertension. Full rights to the product candidate will revert back to Pluristem.
- A small Phase 1 study conducted by United in September 2014 showed an encouraging but limited efficacy trend.