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Immune Reconstitution Data From Phase 1/2 Clinical Study Of Transplant Therapy Presented.

HOUSTON, Texas, February 23, 2019 -- Gamida Cell Ltd. (NASDAQ: GMDA) announced that translational data from the completed Phase 1/2 clinical study of NiCord were reported in an oral presentation at the recent Transplantation & Cellular Therapy (TCT) meetings of he American Society for Blood and Marrow Transplantation (ASBMT) and Center for International Blood and Marrow Transplant Research (CIBMTR).

The data demonstrated that treatment with NiCord, an investigational advanced cell therapy designed to enhance and expand the life-saving benefits of bone marrow transplant for patients with hematologic malignancies, resulted in rapid and robust immune reconstitution.

NiCord is being evaluated in an international, randomized Phase 3 study in patients with hematologic malignancies.

Reconstitution of a patient's bone marrow and immune system is a crucial factor in recovery following allogeneic hematopoietic stem cell transplant.

"We were particularly encouraged by the finding that reconstitution of CD4+ T cells with NiCord treatment was at least as fast as transplant with unmanipulated cord blood and unrelated bone marrow in adolescents and young adults, who typically achieve more rapid recovery than adults." said Jaap-Jan Boelens of Memorial Sloan Kettering Cancer Center.

Despite the curative potential of bone marrow transplants, it is estimated that more than 40 percent of eligible patients in the U.S. do not receive one for various reasons, including finding a matched donor.

Even for patients who do receive a transplant, treatment is not always effective and can lead to serious complications that can dramatically affect quality of life.

NiCord is intended to address the current limitations of bone marrow transplant by providing a therapeutic dose of cells while preserving the cells' functional therapeutic characteristics.

The presentation described in-depth immune reconstitution data from the completed Phase 1/2, multi-center clinical study of NiCord as a stand-alone graft after myeloablative therapy in patients with high-risk hematologic malignancies.

Immune reconstitution for 27 patients receiving NiCord was compared to retrospective cohorts of adolescent and young adults with hematologic malignancies receiving unmanipulated cord blood transplantation (unCBT, n=27) or unrelated bone marrow transplantation (BMT, n=20).

The primary endpoint was the probability of achieving CD4+ immune reconstitution (>50x106/L) within the first 100 days. Secondary endpoints included the recovery of B cells, CD4+ T cells and natural killer (NK) cells during the first year after transplantation.

Analysis showed that 91 percent of patients receiving NiCord achieved successful immune reconstitution of CD4+ T cells at 100 days after transplantation.

Reconstitution of T cells in the NiCord group (median age 41.5 years) was similar to the unCBT and BMT cohorts (median age 15.4 and 14.3 years, respectively), despite the younger age of the cohorts, who would be expected to reconstitute faster.

In addition, reconstitution of a number of cell types, including B cells (p = 0.02) and NK cells (p < 0.001), was significantly faster after transplantation with NiCord compared to the cohorts, and suggests that NiCord reconstitutes diverse functions of the immune system.

These findings may be explained by the higher stem cell dose and proliferative capacity of NiCord.

NiCord, the company's lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).

NiCord is an investigational therapy: its safety and efficacy have not been evaluated by the FDA or any other health authority.

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Publication:Stem Cell Business News
Article Type:Clinical report
Date:Mar 4, 2019
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