Gamida Cell: Further positive blood cancer trial results

Gamida Cell

The group treated with Gamida Cell's NiCord had a shorter time to engraftment, fewer infections, and a lower mortality rate.

Stem cell company Gamida Cell, controlled by Clal Biotechnology Industries (an 18% stake) and Elbit Medical Technologies Ltd. (TASE:EMTC) (25%), today announced additional results from the trial of NiCord, its leading product, for the treatment of blood cancer. Following the announcement, the shares of Clal Biotechnology and Elbit Medical rose by 1.93% and 6.25%, respectively, giving the companies market caps of NIS 424 million and NIS 156 million, respectively.

Gamida Cell said that researchers from Duke University, one of the medical centers that took part in the clinical trials of the product over the past 18 months, had compared the results of treatment with NicoCord of 18 of its patients with 101 patients receiving ordinary umbilical cord blood, the treatment over which Gamida Cell is attempting to demonstrate NiCord's superiority. This is the first comparison of patients treated at Duke University to a prospective control group treated by the same doctors (Gamida Cell's official trial, conducted on 30 patients, had no control group).

The trial showed that in the group treated with NiCord, the time to engraftment was shorter than in the control group. The treatment group had a lower rate of infections, a lower mortality rate, and spent more time alive and out of the hospital during the first 100 days post-transplantation than the control group. The differences had a high statistical significance.

NiCord is scheduled to enter Phase III clinical trials in June, and the trial is expected to take several years. Meanwhile, the company is continuing its Phase II trial, even though the US Food and Drug Administration (FDA) does not require it, in order to maintain the expertise of the medical centers in the trial and avoid errors in transplanting the product when the Phase III trial begins.

NiCord is designed to improve the density of the stem cells in an umbilical cord blood unit in order to make it possible to transplant umbilical cord blood in adult blood cancer patients. The treatment is current suitable mainly for children weighing up to 45 kilograms. Gamida Cell formerly had a product named StemEx, which used the same technology, developed in cooperation with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), but when it was learned that the course of trials for the product would be longer than planned, it was decided to concentrate on NiCord, the next generation product, which is designed to be more effective, and which Gamida Cell fully owns.

Novartis owns 20% of Gamida Cell, and previously attempted to obtain full ownership, but eventually gave up the idea (twice). Several months ago, Novartis increased its stake in Gamida Cell to a value of $200 million.

Published by Globes [online], Israel business news - - on April 6, 2016

© Copyright of Globes Publisher Itonut (1983) Ltd. 2016

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