Phase II Clinical Research Study of VGX-3100 for the Treatment of Cervical Intraepithelial Neoplasia 2/3 or 3

Overview

Women diagnosed with cervical intraepithelial neoplasia (CIN) 2/3 or 3 typically undergo an ablation therapy often involving surgery to remove these precancerous cells. Inovio Phamaceuticals is conducting a clinical research study to assess the effectiveness and safety of its investigational therapeutic vaccine, VGX-3100, that may stimulate the body’s immune system to clear these precancerous cells.

All women who choose to participate in this phase II clinical research study will receive VGX-3100 three times over a three month period and be evaluated for a total of 88 weeks .  Chosen randomly, some women will receive a placebo. To participate in the study, you must be between 18 and 55 years old, among other study criteria which you can view in the eligibility requirements below.

This research is being conducted by physicians in approximately 22 locations in the United States, Canada, Australia, South Korea and South Africa and will include approximately 150 women. The locations are listed below.

Cervical Dysplasias and Cancer Caused by HPV

Cervical cancer is caused by various types of human papillomavirus. Many people who have HPV may not show signs or symptoms. They can pass the virus to others without even knowing it. Approved preventive vaccines, like Gardisil® and CervarixTM, aimed at inducing immunity in non-infected individuals are effective at protecting against HPV infection. However, once a person has an established infection, these vaccines are ineffective for preventing development of cervical dysplasias and cancer.

Cervical cancer is unique among all cancers in having an identifiable, slow-progressing precancerous stage. While 70% of HPV infections clear naturally, persistent infections may lead to benign atypical squamous cells of undetermined significance (ASCUS) and then further progress to the precancerous CIN stages that typically precede cervical cancer. HPV Types 16 and 18 are the two sexually transmitted strains thought to cause up to 70% of cervical cancer cases.

In the case of high-grade dysplasias designated as CIN 2/3 or CIN 3, ablative or surgical procedures are used to remove the precancerous lesions. These same procedures are used to remove cervical cancer. These procedures may be unappealing due to their potential for disfigurement and possible negative impact on reproductive potential.

VGX-3100 Therapeutic Vaccine

VGX-3100 is a therapeutic synthetic vaccine candidate that may have the potential to treat cervical dysplasias and cancers. This vaccine candidate is designed to place into patients' cells DNA code that enables these cells to produce the E6 and E7 antigenic proteins that are part of HPV and can cause detrimental cell changes of the cervix. The intent is to trigger an immune response that may clear cells infected with the E6 and E7 proteins.

Inovio's method involves injection of the vaccine into the patients’ deltoid (shoulder) muscle  followed by the application of controlled electrical pulses. These pulses enhance the entry of the vaccine into cells in order to allow the cell to then produce the E6 and E7 proteins.

There is no ablation or surgical procedure.

VGX-3100 Phase II Clinical Study

VGX-3100 is in phase II testing to assess the safety and efficacy of this synthetic vaccine for the treatment of cervical dysplasia.

The primary goal of the study is to determine the number of women with histopathologically confirmed CIN 2/3 or CIN 3 associated with HPV Type 16 or HPV Type 18 whose cervical lesions regress to CIN 1 or less nine months after the first treatment.

The VGX-3100 study is a randomized, double-blinded study. “Randomized” means that women in the study will be randomly assigned to one of two groups. One group of women will receive VGX-3100; the other will receive a placebo. “Double-blinded” means that neither the participant nor the study physician will know the group to which the participant has been assigned. 

All women in the study who receive the vaccine will receive 1 ml of VGX-3100 delivered by electroporation at the initiation of the study, followed by the same treatment one month and three months later.  Their progress will be evaluated for 88 weeks.

Approximately 150 women are expected to participate in the study.

Common Questions and Answers

Are there side effects of the study vaccine?

As with any experimental medicine, it is not always possible to predict all of the potential risks. However, in previous human studies there were no vaccine-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment. Before you elect to participate in the study, talk to your doctor about the potential risks and benefits associated with the study.
 
Do I have to pay any out-of-pocket costs?

There is no charge for VGX-3100 study-related tests, procedures or office visits. The study medication, VGX-3100, will be provided at no charge.

Your Eligibility for the Study

You may be eligible if you meet the following criteria:

•Female age 18-55 years

•Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from a biopsy less than eight weeks prior to the first treatment, with no evidence of invasive cancer in any specimen

•Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);

You are not eligible if you meet the following criteria:

•Pregnancy or breastfeeding;

•History of previous therapeutic HPV vaccination; 

•Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);

•Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);

•History of seizures (unless seizure free for 5 years);

•Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;

•Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;

If you are interested in participating in the VGX-3100 study, your doctor can discuss additional eligibility requirements with you. Full eligibility criteria can be found at:

http://www.clinicaltrials.gov/ct2/show/NCT01304524?term=NCT01304524&rank=1

You may also discuss this clinical study further with an
Inovio representative.

VGX-3100 Clinical Study Locations

United States

Arizona
Chandler
Tucson

California
Colton
La Mesa

Florida
Boynton Beach

Maryland
Baltimore
 
Missouri
Kansas City 

New York
Bronx, New York
 
North Carolina
Winston-Salem 

Ohio
Englewood 

Oklahoma
Oklahoma City
 
Pennsylvania
Philadelphia 

South Carolina
Columbia 
Myrtle Beach
 
Utah
Murray

Washington
Renton 

Australia
Melbourne, Victoria 

Canada
Vancouver, British Columbia
Montreal, Quebec

Korea  
Seoul
 
South Africa
Cape Town