Thursday, 11 April 2013

Gamida cell reports positive data from its Phase II & III trials on blood cancer patients

Gamida cell just announced new data from its Phase II & III trials, regarding the efficacy and safety of StemEx, a stem cell product for leukemia and lymphoma patients.

StemEx is a graft, containing stem cells isolated and expanded from umbilical cord blood. Purpose of the product is to give an alternative answer to any patient that needs a hematopoietic stem cell transpant after failing to find a matched donor.

The trials were conducted all over the world, in 25 different bone marrow transplant centres and a total of 101 patients with haematologic malignancies (cancers affecting blood, bone marrow, and lymph nodes) following myeloablative therapy were treated with StemEx. All patients had previously failed to find a family-related matched donor.

According to the press release, StemEx was shown to have the following advantages:
  • Improves survival ratio at 100 days post transplantation. 
  • Increases the ratio of patients with early hematopoietic recovery
  • Shortens engraftment time
  • Does not create a significant difference in the level of grade III-IV acute GvHD (graft versus host disease)
  • Doesn't not increase the occurrence of adverse effects 

Professor Guillermo Sanz,  lead principal investigator of the StemEx trial who also recruited most of the patients, highlighted the advantages of StemEx:

“We are very enthusiastic as we have personally witnessed very good results in the StemEx® Phase II/III study. Unequivocally, StemEx® has shown to be a reliable expansion procedure. StemEx® produces a higher amount of stem/progenitor cells, has a shorter time to engraftment and has demonstrated a reduced non-relapsed mortality in comparison with un-manipulated cells derived from cord blood.”

Professor Guillermo Sanz talking about the advantages of StemEx 

Dr. Yael Margolin, president and CEO of Gamida Cell, talked about the company's future plans:

“The company plans to meet with the FDA this spring and with the EMA this autumn to continue discussions on the regulatory pathway for marketing approvals,”

Gamida Cell is a company based in Israel, focusing in the development of stem cell products for transplantation and regenerative purposes. Their stem cell pipeline focuses in the treatment  of several conditions, including:
  • Acute radiation syndrome
  • Autoimmune disease
  • Blood cancers like leukemia
  • Metabolic diseases 
  • Neutropenia 
  • Non-malignant hematological diseases like hemoglobinopathies
  • Solid tumors

You can read the official press release here

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