- All PLX-treated groups showed improvements in survival rates compared to untreated groups
- PLX-R18 cells did not increase leukocyte levels in non-irradiated NHPs, indicating no requirement to determine levels of radiation exposure prior to administration
- Data will inform a pivotal trial that could support marketing authorization under the FDA’s Animal Rule regulatory pathway
Hematopoietic Stem Cells (HSCs)
Governments on Alert and Stockpiling Antidotes for Nuclear Accidents and Attacks
Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years.
The recent escalation of tensions between North Korea and the U.S. may give the American government cause to up its investment in ARS antidotes. During a military parade on April 15th, North Korea displayed weapons including an intercontinental ballistic missile (ICBM) that could be capable of reaching the U.S. ARS may have just become a larger threat to health than it was just a few weeks ago. [Read more…]
Future of Regenerative Medicine with Kyle Cetrulo of AuxoCell
I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in HSCT
Phase 3 study of NiCord commenced last month in blood cancer patients
Jerusalem, Israel, March
23, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” said Gamida Cell president and CEO Dr. Yael Margolin. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization.” [Read more…]
$15M Upstate Cord Blood Bank Opens in Syracuse, NY
On February 9, 2017, Upstate Cord Blood Bank in Syracuse, NY, opened its doors. The planning and construction was a lengthy process and cost $15 million.
The project origins go back to 2006 when the center was first proposed. Unfortunately, state funding for the project was delayed in 2008 due to economic conditions, and the build out of the cord blood bank was further delayed when design changes were implemented during construction. Senator John DeFrancisco had a pivotal role in securing state funding for the cord blood bank. [Read more…]
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