Frequently Asked Questions

What are the symptoms of basal cell carcinoma?

Signs may include:

  • Non-healing skin lesion
  • Skin spot that may have started like a pimple, but is getting slowly larger and will not go away
  • Pink or flesh-colored translucent bump with dilated blood vessels
  • Skin spot that bleeds or scabs easily
  • Enlarging, fragile spot on the skin

Who should apply?

Someone should consider applying if he or she meets the following three criteria:

  • Diagnosed with basal cell carcinoma or has a suspected growth
  • Willing to attend up to six (6) in-person study visits over a two-week period
  • Between 45-75 years old

Why participate?

The information learned from the study may help find new treatment options in the future for people with basal cell carcinoma. If you qualify for the study, you will receive the investigational treatment VP-315, with an injection directly into the tumor to cause cell death, which may offer a non-surgical option for patients suffering from skin cancer. 

Patients will also have all enrolled lesions removed at the end of the study at no cost.

What are the costs to participate?

There is no cost to participate. Qualified participants do not pay for the study medication, clinic visits, or study-related medical procedures and laboratory tests. Participants will be compensated for the clinic visits they complete.

Will there be compensation for participation?

Yes. Qualified patients may receive up to $2,500 for their attendance at all scheduled study visits.

Are there any risks to participating?

This study is the first time VP-315 will be given to people. As all drugs and medical procedures carry a risk of side effects, it is possible that participants may experience some discomfort or other reactions. The study staff will explain these potential risks before participants decide whether to participate in the study.

Can I change my mind about participating?

Participation is entirely voluntary. Even if you are already involved in the study, you can change your mind at any time for any reason.

What is being researched in this study?

In the VP-315 study, we are evaluating the safety and efficacy of an investigational drug called VP-315. VP-315 is designed to use the body’s defense peptides to locate and cause cell death in basal cell carcinoma tumors through an injection directly into the tumor. The goal is to create a nonsurgical alternative in the treatment of basal cell carcinoma.

Does qualifying for the study ensure my participation?

Before a potential participant decides whether to participate in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by both the participant and caregiver, the screening period of the study begins. During this period, the staff will review medical history and conduct a series of study-related exams, lab tests, and a biopsy, if not already completed within the screening window, of the suspected growth to determine if it is basal cell carcinoma. Participants who meet all study requirements will be asked to participate.

What will happen during the study?

If you qualify for the VP-315 study, you will be asked to attend up to six (6) in-person study visits over a two-week period, generally in groupings of three (3) consecutive days. These visits will last approximately 2.5 hours each.

During these visits, the clinical team will run a series of tests (e.g. vital signs, electrocardiographic and adverse event assessments). Participants may also be injected with VP-315 in up to two lesions, which will be monitored by photography. At the end of the study, all enrolled basal cell carcinoma lesions will be surgically excised with a 3mm margin, either 4-6 or 12-13 weeks after receipt of the first injection (depending on participant’s enrollment date / cohort) and a tissue sample will be sent for analysis and histology. Site staff will share the results with participants once the report is available.

What if I have more questions?

To learn more, please feel free to contact us at any time by emailing [email protected] directly.

What happens after the study is complete?

The results of each participant’s excision will be reviewed with him or her on their last study assessment day. After finishing the study, participants may consider participating in future studies.

If you have additional questions, contact us anytime at [email protected]