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The European Commission (EC) has granted orphan designation to NLA101 as an adjunct to hematopoietic stem cell transplant (HSCT).
NLA101 is a universal, off-the-shelf, stem and progenitor cell therapy intended to provide a short-term bridge for hematopoietic recovery while also providing long-term immunologic and clinical benefits in HSCT recipients.
NLA101 is a product of Nohla Therapeutics Inc.
The company says more than 125 infusions of NLA101 have been administered since 2009. The therapy is under investigation in patients receiving intensive chemotherapy as well as in HSCT recipients.
Results from a pilot study of NLA101 in HSCT recipients were presented at the 2014 ASH Annual Meeting.
In this study, 15 patients with hematologic malignancies underwent myeloablative cord blood transplant, with or without NLA101.
Patients who received NLA101 had a significantly reduced median time to platelet and neutrophil recovery, compared to controls. At 5 years, disease-free survival was 86% in the NLA101 group and 67% in the control group.
The rate of grade 3-4 acute graft-versus-host disease was 0% in the NLA101 group and 29% in the control group. The rate of transplant-related mortality was 0% and 22%, respectively.
Phase 2 studies of NLA101 in chemotherapy and HSCT recipients are ongoing.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.
The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure. 
The European Commission (EC) has granted orphan designation to NLA101 as an adjunct to hematopoietic stem cell transplant (HSCT).
NLA101 is a universal, off-the-shelf, stem and progenitor cell therapy intended to provide a short-term bridge for hematopoietic recovery while also providing long-term immunologic and clinical benefits in HSCT recipients.
NLA101 is a product of Nohla Therapeutics Inc.
The company says more than 125 infusions of NLA101 have been administered since 2009. The therapy is under investigation in patients receiving intensive chemotherapy as well as in HSCT recipients.
Results from a pilot study of NLA101 in HSCT recipients were presented at the 2014 ASH Annual Meeting.
In this study, 15 patients with hematologic malignancies underwent myeloablative cord blood transplant, with or without NLA101.
Patients who received NLA101 had a significantly reduced median time to platelet and neutrophil recovery, compared to controls. At 5 years, disease-free survival was 86% in the NLA101 group and 67% in the control group.
The rate of grade 3-4 acute graft-versus-host disease was 0% in the NLA101 group and 29% in the control group. The rate of transplant-related mortality was 0% and 22%, respectively.
Phase 2 studies of NLA101 in chemotherapy and HSCT recipients are ongoing.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.
The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.
The European Commission (EC) has granted orphan designation to NLA101 as an adjunct to hematopoietic stem cell transplant (HSCT).
NLA101 is a universal, off-the-shelf, stem and progenitor cell therapy intended to provide a short-term bridge for hematopoietic recovery while also providing long-term immunologic and clinical benefits in HSCT recipients.
NLA101 is a product of Nohla Therapeutics Inc.
The company says more than 125 infusions of NLA101 have been administered since 2009. The therapy is under investigation in patients receiving intensive chemotherapy as well as in HSCT recipients.
Results from a pilot study of NLA101 in HSCT recipients were presented at the 2014 ASH Annual Meeting.
In this study, 15 patients with hematologic malignancies underwent myeloablative cord blood transplant, with or without NLA101.
Patients who received NLA101 had a significantly reduced median time to platelet and neutrophil recovery, compared to controls. At 5 years, disease-free survival was 86% in the NLA101 group and 67% in the control group.
The rate of grade 3-4 acute graft-versus-host disease was 0% in the NLA101 group and 29% in the control group. The rate of transplant-related mortality was 0% and 22%, respectively.
Phase 2 studies of NLA101 in chemotherapy and HSCT recipients are ongoing.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.
The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.