MONTREAL, April 23, 2019 — ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies. The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers. [Read more…]
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Talaris Therapeutics Receives RMAT, Raises $100M, Announces Promising Phase II Data for Kidney Transplant
Talaris Therapeutics’ RMAT and Promising Phase 2 Data of Cell Therapy for Living Donor Kidney Transplant Recipients
BOSTON & LOUISVILLE, Ky.–Apr 18, 2019–Talaris Therapeutics, Inc., formerly Regenerex, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced full results of its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) recipients. The therapy’s strong durability of benefit and safety profile support the initiation of a Phase 3 clinical trial in LDKT later this year.
Cell and Gene Therapies (CGT): Italy at the forefront with Anemocyte, which in Miami announces the creation of an important centre of excellence and a revolutionary drone transport system
*Photo credits: NDS – Nicolich Design Studio
The new Italian industrial complex entirely dedicated to the development and production of cell and gene therapies is called EXELLULA and it will be a world centre of excellence for nonviral technologies. FLYn’ICE, on the other hand, is a project for the transport with drones of Cell and Gene Therapies (CGT) products.
NeurExo Sciences to Host Teach-in Featuring Michael Chopp, PhD and Pioneering Exosome Technology
— Research indicates exosomes have therapeutic potential for improving recovery after stroke, traumatic brain injury —
ATLANTA and DETROIT, January 23, 2019 – NeurExo Sciences, LLC (NXS), a biopharmaceutical company and subsidiary of NeuroTrauma Sciences, LLC, will be hosting a teach-in event featuring leading exosome researcher, Michael Chopp, Ph.D., Vice Chairman, Department of Neurology and Scientific Director, Neurosciences Institute, Zoltan J. Kovacs Chair of Neuroscience Research at Henry Ford Health System (HFHS), Detroit, and Distinguished Professor of Physics, Oakland University (MI). Dr. Chopp’s presentation will provide a primer and overview of exosomes, small extracellular vesicles that provide a means of mediating intercellular communication. He also will focus on his team’s pioneering technology employing exosomes engineered with enriched microRNA for the purpose of treating neurological disease and injury, including stroke and traumatic brain injury (TBI). [Read more…]
StemCyte Receives Phase II IND Clearance for HLA-Matched Cord Blood Mononuclear Stem Cells (MC001)
StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and Drug Administration (FDA)
BALDWIN PARK, Calif., Jan. 3, 2019 — StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury. [Read more…]
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