Pluristem Applies For Orphan Drug Application For PLX-PAD

Pluristem Therapeutics, Inc. announced in a press release that it submitted an Orphan Drug Application to the Food and Drug Administration (FDA) for PLX-PAD. PLacental eXpanded (PLX-PAD) is indicated for severe preeclampsia. Placenta-based cell therapies are a drug delivery system of therapeutic proteins that respond to inflammatory conditions and ischemic diseases. Zami Aberman, Pluristem Chairman and CEO said, “Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program.”

Preeclampsia

Preeclampsia is a condition during pregnancy and afterwards that causes women and babies to get sick and sometimes die. Preeclampsia and related disorders like eclampsia and HELLP cause blood pressure to rise, which may lead to organ failure, stroke, seizure, and the mother’s or baby’s death. The condition is a leading complication of pregnancy and results in stillbirths and premature delivery. Only abortion or delivery treats the condition. Worldwide, 6 to 8% of pregnancies result in preeclampsia, costing the healthcare system over three billion dollars each year. 

PLacental eXpanded

The PLacental eXpanded (PLX-PAD) agent is derived from human placenta. PLX-PAD cells, also known as Placental-derived MSCs, are stromal cells from human placentae. They are grown and expanded in vitro in bioreactors in clean room facilities. The production process involves several steps. The placenta is cut into pieces, washed, and incubated with collagenase, which digests the tissue. It is then filtered, washed, and seeded in growth medium. The finished product is injected intramuscularly.

Preeclampsia Steering Committee  

Pluristem announced the formation of Preeclampsia Steering Committee on February 11, 2014. The committee’s purpose is to advance PLacental eXpanded (PLX) cell therapies. Pluristem CEO Zami Aberman said, "The caliber of medical and scientific thought leaders who have joined our Preeclampsia Steering Committee is a testament to the promise of our PLX cell therapy as a potential treatment for this disease."

The committee will guide the company through the development phases, with an emphasis on clinical trials. Members will advise on study design, endpoints, and will analyze patient feedback. Committee members include James M. Roberts, M.D. of the University of Pittsburgh, George R. Saade, M.D. of the University of Texas, Baha M. Sibai, M.D. of the University of Texas, David Williams, PhD FRCP of the University College London, and Simcha Yagel, M.D. of the Hadassah Medical Center.

Source:

http://www.pluristem.com/index.php/press-room/111-press-releases/press-room-2014/463-20-feb-2014