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BioBypass

Phase 2

Moderate to Severe Angina Pectoris | Gene therapy | Other |Precigen, Inc.|Trials Updated: May 13, 2011

BioBypass development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

BioBypass clinical trials

BioBypass · 1 trial · 1 indication

Phase 2 1
NCT00215696A Study to Treat Patients Whose Chronic Angina Symptoms Are Not Relieved by Medication and Have an Area of the Heart That Cannot be Treated by Standard TherapiesModerate to Severe Angina Pectoris
COMPLETED129 Analytics
PHASE2COMPLETED
A Study to Treat Patients Whose Chronic Angina Symptoms Are Not Relieved by Medication and Have an Area of the Heart That Cannot be Treated by Standard Therapies
Moderate to Severe Angina PectorisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in total exercise duration on exercise tolerance test (ETT, using the bicycle ergometry test protocol) at week 26.

Secondary Endpoints

Change of reversible perfusion defect size in SPECT perfusion study at week 26
Total exercise duration at weeks 12 and 52
Time-to-onset of 1mm ST depression on ETT at weeks 12, 26, 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
BioBypass®GENETIC -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Age greater than or equal to 18 years and less than or equal to 80 years; * Written informed consent obtained prior to any study dictated procedure; * Moderate to severe angina (CCS Angina Class II-IV) despite optimal medical therapy; * Treated with optimal unchanged antiangin...

Countries:DenmarkIsrael
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Frequently asked questions about BioBypass

What is BioBypass used for?

BioBypass is an investigational gene therapy being studied for moderate to severe angina pectoris. It is intended for patients whose chronic angina symptoms are not relieved by medication and who have an area of the heart that cannot be treated by standard therapies.

Who is developing BioBypass?

BioBypass is being developed by Precigen, Inc., which trades under the ticker symbol PGEN. The company is the sponsor of the clinical program evaluating this gene therapy for moderate to severe angina pectoris.

What phase is BioBypass in?

BioBypass is in Phase 2 clinical development. It is an investigational gene therapy and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is BioBypass in?

BioBypass has been evaluated in one completed Phase 2 clinical trial, NCT00215696. The study enrolled 129 patients with moderate to severe angina pectoris in Denmark and Israel. It was a randomized, double-blind trial for patients whose symptoms were not relieved by medication.

Is BioBypass the same as BioBypass®?

Yes, BioBypass and BioBypass® refer to the same investigational gene therapy developed by Precigen, Inc. The registered trademark symbol is simply a stylized version of the name used in some materials.