VEGF-2: Patient Information

What Is It? Vascular Endothelial Growth Factor (VEGF) is one of several growth hormones that are naturally produced in your body. These hormones are specific to your blood vessels and cause them to start the growth of tiny arteries, called collaterals, where blood flow is limited. For example, when the arteries that deliver blood to your heart muscle, called coronary arteries, are narrowed or blocked, your body will secrete growth factors, such as VEGF and FGF to grow new collaterals. These new arteries will deliver blood flow to the areas that are compromised. However, collaterals are much smaller than the major arteries in your heart and deliver smaller amounts of blood flow to the heart muscle.

How do you get VEGF? The gene for VEGF-2 is available only in clinical trials that are under the Federal Drug Administration's (FDA) supervision. It is not approved by the FDA for general use and it is currently being studied in a Phase IIa clinical trial. Testing of VEGF on human subjects is in the initial stages. The standard phases used by the FDA are listed below.

Phase I - The main purpose is to determine the correct dose and initial safety results in people. This phase of the study is complete for the VEGF gene. It appears to be safe and there were encouraging results.
Phase II - The next phase of the study has just begun. It is designed to evaluate the effectiveness of the drug. This phase should take about 6 months to a year.
Phase III - This phase will entail a large-scale study with many patients. It should also take about 1 year.
FDA Approval - The results of the phases are submitted to the FDA and it will probably take 2-3 years for approval after that.

What's involved with the VEGF-2 gene study?
The VEGF gene Phase II clinical trial is being done at about 4 hospitals in the United States. Patients must go through a screening process to evaluate if they qualify for the study (including treadmill exercise tests, cancer screening, and eye exams). Once it is determined that they qualify, patients sign a consent form and are enrolled into the clinical trial. The VEGF-2 gene is delivered to the heart by injection directly into the heart muscle during an open-heart surgery. Patients are followed for 12 months.

Who qualifies for Phase III of the study?
There is an extensive screening process for patients enrolled in the VEGF-2 clinical trial. The following are some of the major qualifications:

Chest pain/angina which interferes with quality of life
Abnormal nuclear perfusion scan
Abnormal coronary angiogram and not a good candidate for surgery or angioplasty

Exclusions for the study include:

A history of cancer (because of the potential for growth of vessels that might nourish tumors)
Severe eye disease i.e., retinopathy (because of the risk of growing new vessels in already compromised eyes)
Abnormal kidney function

Participants must be willing to be seen at Hennepin County Medical Center approximately 5 times over the first 30 days and to be hospitalized for 3-5 days for a mini-thoracotomy to inject the VEGF gene. After that, they must return for 2-, 4-, 8-, and 12-week follow-up visits and 5-, 7-, and 9-month follow-up visits.

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