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StemEx

Phase 2

Hematologic Malignancies | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Jul 10, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

StemEx · 1 trial · 7 indications

Phase 2 1
NCT00469729Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative TherapyHematologic Malignancies
COMPLETED101 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy
Hematologic MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall 100-day mortality
100 days

Secondary Endpoints

180 day mortality, acute Graft versus Host Disease (GvHD) grades III-IV, engraftment failure
180 days
Safety and tolerability measures: The incidence and frequency of adverse experiences, acute toxicity, laboratory data and vital signs follow-up.
180 days
Proportion of overall mortality at 1 year
One year post transplant
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
StemExEXPERIMENTAL -

Interventions

NameTypeDescription
StemEx®DRUGThe stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood cells, which is infused to subject at a rate of 1-3 ml/min in combination with non-manipulated cells derived from the same cord blood unit.
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Eligibility Criteria

Age Range12 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. Clinical diagnosis of AML or ALL: CR2 or subsequent complete remission (CR) or CR1 with high-risk features or relapse with \< 10% blasts in BM and no circulating blasts. 2. Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to Gleevec or in CP2 or...

Countries:United StatesHungaryIsraelItalySpain
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Frequently asked questions about StemEx

What is StemEx used for?

StemEx is an investigational small molecule being studied for the treatment of hematologic malignancies, including acute myeloid leukemia, lymphoid leukemia, chronic myeloid leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, and myelodysplastic syndromes. It is administered following myeloablative therapy in patients with high-risk disease.

Who is developing StemEx?

StemEx is being developed by Teva Pharmaceutical Industries Limited, whose stock trades under the ticker TEVA. The drug is currently in clinical development for hematologic malignancies.

What phase is StemEx in?

StemEx is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities.

What clinical trials is StemEx in?

StemEx has one completed clinical trial, NCT00469729, which evaluated its efficacy and safety in subjects with high-risk hematologic malignancies following myeloablative therapy. The trial enrolled 101 participants across the United States, Hungary, Israel, Italy, and Spain.

Is StemEx the same as any other drug?

StemEx is the name used in clinical trials for this investigational therapy. No alternative names have been reported for this drug in the available clinical trial information.