Umbilical cord blood stem cell developer Gamida Cell Ltd. has received a favorable sign for its Phase III clinical trial of its blood cancer treatment, StemEx. After the Data Monitoring Committee reviewed the trial results on the first 15 patients of the planned 100-patient study, it recommended continuing the study as planned.
The decision is a positive indication, especially with regard to StemEx's safety, but also with regard to its effectiveness. An independent committee is required to halt the trial, if the trial is found to be hazardous to patients. If the committee decides to proceed with the trial, this means that the committee saw no severe side effects from the treatment.
StemEx is being evaluated as a therapeutic treatment for adolescents and adults with blood cancers such as leukemia and lymphoma, who cannot find a family related matched bone marrow donor. The trial is a joint study with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA, which invested $3 million in Gamida Cell.
In the case of patients with blood cancer, even the absence of complete effectiveness jeopardizes their health, and it is better to switch to a different treatment. Therefore, the Data Monitoring Committee's decision to pursue the trial probably means that the treatment has some degree of effectiveness, even if it is not yet clear if the trial will be a success.
Gamida Cell expects to complete recruitment of the 100 patients for the trial by the end of 2011. Only then will it be allowed to analyze the results and submit them to the US Food and Drug Administration (FDA).
Gamida Cell is run by president and CEO Dr. Yael Margolin. The company has raised $40 million to date. Its current shareholders include Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Israel Healthcare Ventures Ltd., Biomedical Investments Ltd., Auriga Partners, Denali Ventures, and Amgen Inc. (Nasdaq: AMGN).
Last week, Elbit Imaging announced that it plans to set up and then float on the Tel Aviv Stock Exchange (TASE) a wholly-owned subsidiary that will hold the company's 60% stake in InSightec Ltd. Ltd. and 28% stake in Gamida Cell. This will give public investors their first chance to gain exposure to Gamida Cell.
Published by Globes [online], Israel business news - www.globes-online.com - on February 11, 2010
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