Caladrius Biosciences

Caladrius Biosciences (NASDAQ: CLBS) is an American biopharmaceutical company active in the field of stem cell therapy and regenerative medicine, particularly (in 2012) of cardiovascular disease.[1]

The company was founded in 1980 and was formerly known as Corniche Group Inc, Phase III Medical Inc[2] and NeoStem, Inc. It is headquartered in New York City, New York.

Cardiovascular disease

In 2012 they started a phase 2 clinical trial of AMR-001 (NBS10), an autologous bone marrow derived cell therapy enriched for CD34+ cells, for Acute Myocardial Infarction.[3][4] Initial results included a statistically significant mortality benefit.[5] After the interim results reported in Nov 2014 the company clarified the changes to the study.[6]

Cancer therapies

The cancer therapies (Melapuldencel-T and ovapuldencel-T) below are an autologous dendritic cell-based immunotherapy using the patients own dendritic cells and samples of their tumour to make dendritic cells aimed at the patients tumour antigens. This should activate T cells to attack the tumour.

Pipeline - Therapies in development

CLBS03
a T regulatory cell therapy candidate for type 1 diabetes - in Phase II.[7]
CLBS20 (Melapuldencel-T)
(Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF) for metastatic melanoma - (based on a new antigen presentation and T cell activation approach) Phase III clinical trials abandoned Jan 2016 (due to competitive therapies).[7]
ovapuldencel-T
(autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF) for ovarian cancer. Phase 2 trial registered.[8] As of January 2016 Not active.
CLBS12
(autologous CD34+ cells) for critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO).[9] As of January 2016 this phase 2 trial has not started. (CD34+ cells include many types of hematopoietic stem cell.)

References

  1. ↑ NeoStem CEO Discusses Adult Stem Cell Therapies, May 14, 2012. Bloomberg Television. 3m35s video. Accessed September 2015.
  2. ↑ EDGAR Search Results – Neostem, EDGAR
  3. ↑ Amorcyte, a NeoStem Company, Enrolls First Patient in PreSERVE Phase 2 Trial for Acute Myocardial Infarction. Jan 2012
  4. ↑ NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction (PreSERVE-AMI)
  5. ↑ Stem Cell Research Reveals Promising Data for Heart Attack Patients. Feb 2015
  6. ↑ NeoStem Provides Further Information Regarding the Design of the Phase 2 PreSERVE AMI Clinical Trial
  7. 1 2 Caladrius Axing 40 Employees, Ending Phase III Study of Lead Candidate. 7 Jan 2016
  8. ↑ Autologous Dendritic Cell-Tumor Cell Immunotherapy for Advanced Epithelial Ovarian Carcinomas
  9. ↑ Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
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