HAIFA, Israel, Nov. 4, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that its PLacental eXpanded (PLX) cells proved to be safe in an animal study assessing maternal and fetal toxicity. The study was conducted at the Charles River Laboratories, one of the world's leading contract research organizations. The results showed that the intramuscular administration of PLX-PAD cells to pregnant rats did not result in any maternal or fetal toxicity. Pluristem will pursue the clinical development of PLX-PAD cells for the indication of preeclampsia based on these results and earlier evidence that the cells were efficacious in preeclamptic animal models.
"Pluristem is extremely pleased with the demonstrated safety of our PLX-PAD cells in pre-clinical models of pregnancy," said Zami Aberman, Chairman and CEO of Pluristem. "This study, together with the work performed by Dr. Brett Mitchell from Texas A&M College of Medicine,suggesting that our PLX-PAD cells are efficacious in preeclamptic animal models, is an important milestone towards our goal of initiating clinical trials for preeclampsia."
In the study, forty-four pregnant female rats were injected intramuscularly with either PLX-PAD at a dosage of 10 million cells (n=22) or cell-free placebo (n=22), on gestational day 13. Throughout the study the pregnant animals were monitored for viability status, body weight and food consumption. On gestational day 21, female rats were examined for ovarian and uterine contents and abnormalities in dams and pups. Charles River's report concluded that the IM injection of PLX-PAD cells in pregnant rats did not result in any maternal or fetal developmental toxicity.About Preeclampsia Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated, it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy. The only known treatment for preeclampsia is abortion or delivery. The disease occurs in previously healthy women after their 20th week of pregnancy, and signs include high blood pressure and significant amounts of protein in the urine. According to the World Health Organization, preeclampsia occurs in approximately 6–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually. About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.