luristem gains approval for an investigational new drug study in South Korea
Another stock to follow today is Pluristem (NASDAQ: PSTI ) , a biotech company focused on cell therapy treatments for a variety of degenerative, blood clot, and autoimmune disorders. The company's pipeline of products consists of treatments derived from stem cells from human placenta, a source considered much less controversial than embryonic stem cells.
Earlier today, Pluristem announced that the South Korean Ministry of Food and Drug Safety had approved its IND (investigational new drug) application to initiate a phase 2 study using its PLX-PAD cells to treat a type of peripheral artery disease known as Intermittent Claudication (IC). South Korea is the fourth country to approve Pluristem's IND for the study, following approvals in the U.S., Germany, and Israel.
Pluristem's phase 2 study for the treatment of IC has a primary endpoint of increasing the maximum walking distance of patients during a treadmill test against a placebo. IC patients generally suffer from aches, numbness, and fatigue in the calf muscle during exercise.
This positive development could help offset the negative press it received in June, after the FDA placed its phase 2 IC study on clinical hold after a patient developed a severe allergic reaction to the treatment. Shares of Pluristem climbed 8% in after-hours trading following the announcement.