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BioBypass

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

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 Pectoris
NCT00215696129
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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 the treatment of moderate to severe angina pectoris, a condition characterized by chest pain due to reduced blood flow to the heart. It is intended for patients whose 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., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. The company is conducting clinical research to evaluate the safety and efficacy of this gene therapy for patients with moderate to severe angina pectoris.

What phase is BioBypass in?

BioBypass is currently in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating moderate to severe angina pectoris.

What clinical trials is BioBypass in?

BioBypass has been studied in a Phase 2 clinical trial registered as NCT00215696. This completed trial enrolled 129 participants with moderate to severe angina pectoris and was conducted in Denmark and Israel. The study was randomized and double-blind, though it did not use a control group.

Is BioBypass a gene therapy?

Yes, BioBypass is a gene therapy. It is being investigated as a treatment for moderate to severe angina pectoris, a condition where the heart muscle does not receive enough blood and oxygen. The therapy is designed to address areas of the heart that cannot be treated by standard revascularization procedures.