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Co-ArgI-PEG modified human arginase I

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Spyre Therapeutics, Inc.|Last Updated: Oct 17, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

Co-ArgI-PEG modified human arginase I · 1 trial · 2 indications

Phase 2 1
NCT02732184A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDSAcute Myeloid Leukemia
COMPLETED29 Analytics
PHASE2COMPLETED
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose and Recommended Phase 2 Dose
4 weeks

The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Secondary Endpoints

Safety profile (changes in physical exam, laboratory measures, reported adverse events)
4 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEB1102 (Co-ArgI-PEG) administered via IV weekly.EXPERIMENTALCo-ArgI-PEG modified human arginase I

Interventions

NameTypeDescription
Co-ArgI-PEG modified human arginase IDRUG -
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Willing and able to provide informed consent * Age 18 and older * Diagnosis of AML or MDS according to the WHO criteria * AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens * MDS refractory to treatment ...

Countries:United StatesCanada
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Frequently asked questions about Co-ArgI-PEG modified human arginase I

What is Co-ArgI-PEG modified human arginase I used for?

Co-ArgI-PEG modified human arginase I is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 2 clinical development and has been studied in patients with AML or Myelodysplastic Syndrome.

Who makes Co-ArgI-PEG modified human arginase I?

Co-ArgI-PEG modified human arginase I is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SYRE.

What phase is Co-ArgI-PEG modified human arginase I in?

Co-ArgI-PEG modified human arginase I is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is Co-ArgI-PEG modified human arginase I in?

Co-ArgI-PEG modified human arginase I has been studied in a completed Phase 2 trial with the identifier NCT02732184. This trial was a multiple dose, dose escalation study in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome, enrolling 29 participants in the United States and Canada.

Is Co-ArgI-PEG modified human arginase I the same as AEB1102?

Yes, Co-ArgI-PEG modified human arginase I is also known as AEB1102. The clinical trial NCT02732184, which evaluated this drug, was titled 'A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS'.