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Polyinosinic:polycytidylic Acid

A new clinical trial is investigating the use of Polyinosinic:polycytidylic Acid, also known as BO-112, for treating basal cell carcinoma (BCC). This Phase 2b study aims to evaluate the safety, tolerability, and effectiveness of BO-112 when injected directly into BCC lesions. The trial focuses on patients with resectable primary low and high-risk basal cell carcinoma, offering a potential new approach to treating this common skin cancer.

Table of Contents

What is BO-112?

BO-112 is a medication being studied for the treatment of basal cell carcinoma, a type of skin cancer. Its active ingredient is polyinosinic:polycytidylic acid, also known as Poly I:C[1]. This drug is administered as a solution for injection directly into the tumor, a method called intratumoral injection[1].

How BO-112 Works

BO-112 is classified as an immunotherapy drug. While the exact mechanism isn’t fully explained in the provided information, immunotherapy drugs generally work by stimulating the body’s immune system to fight cancer cells. The intratumoral injection method allows the medication to be delivered directly to the cancer site[1].

Target Condition: Basal Cell Carcinoma

Basal cell carcinoma (BCC) is the most common type of skin cancer. It typically develops on areas of skin exposed to the sun, such as the face and neck. The clinical trial is studying BO-112 for both low-risk and high-risk BCC[1].

Clinical Trial Details

The clinical trial for BO-112 is called SPOTLIGHT 204. It’s a Phase 2b trial, which means it’s testing the drug’s effectiveness and safety in a larger group of people after initial safety studies have been completed. Key details include:

  • It’s an open-label trial, meaning both patients and doctors know which treatment is being given.
  • The trial is non-randomized, so all eligible participants receive BO-112.
  • The main goal is to evaluate how well BO-112 works when injected into BCC tumors[1].

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key requirements include:

  • Being 18 years or older
  • Having primary resectable (removable by surgery) low or high-risk basal cell carcinoma
  • Having adequate organ function
  • Not being pregnant or breastfeeding
  • Not having received certain other treatments recently
  • Not having certain other medical conditions that might interfere with the study[1]

It’s important to note that these are just some of the criteria. A healthcare provider can provide more detailed information about eligibility.

Potential Benefits

The potential benefits of BO-112 are still being studied, but the trial aims to evaluate:

  • How effective BO-112 is in treating BCC
  • Whether it can lead to complete removal of the cancer, as assessed visually and through pathology (examination of tissue samples)
  • How it affects the recurrence rate of BCC after treatment[1]

Safety Considerations

As with any medical treatment, safety is a crucial consideration. The trial will closely monitor:

  • Side effects (adverse events) of BO-112
  • Any serious adverse events
  • Any side effects that lead to stopping treatment or are life-threatening[1]

It’s important to remember that BO-112 is still an experimental treatment. While it shows promise, its full effects and potential risks are not yet fully known. Patients considering participating in the trial should discuss all potential risks and benefits with their healthcare provider.

Aspect Details
Drug Name Polyinosinic:polycytidylic Acid (BO-112)
Trial Phase Phase 2b
Condition Studied Resectable primary low and high-risk basal cell carcinoma
Administration Method Intra-lesional injection
Primary Objective Evaluate efficacy of BO-112 in resectable primary low or high-risk BCC
Secondary Objectives Evaluate safety, tolerability, and recurrence rate
Key Inclusion Criteria Age ≥18, primary resectable BCC, adequate organ function
Key Exclusion Criteria Pregnancy, immunocompromised status, recent cancer therapies
Primary Endpoint Complete visual and pathological response at surgery
Maximum Daily Dose 2 mg
Maximum Total Dose 6 mg
Treatment Duration Up to 3 weeks

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate the effectiveness, safety, and tolerability of BO-112 when injected directly into basal cell carcinoma (BCC) lesions in patients with resectable primary low or high-risk BCC.
  • Who can participate in this trial? Participants must be at least 18 years old, have primary resectable low or high-risk basal cell carcinoma, and meet other specific criteria. Some exclusions include being pregnant or lactating, having certain medical conditions, or having received specific treatments recently.
  • How is BO-112 administered in this trial? BO-112 is administered through intra-lesional (IL) injection directly into the BCC lesions. The maximum daily dose is 2 mg, with a maximum total dose of 6 mg over a treatment period of up to 3 weeks.
  • What are the main outcomes being measured in this trial? The primary outcome is the complete visual and pathological response at surgery, assessed by central review. Secondary outcomes include the occurrence of adverse events, pathological and visual responses during the study, and recurrence rates at 12 and 24 months after surgery.
  • Are there any restrictions for participants during the trial? Yes, participants must agree to use effective birth control methods during treatment and for 4 weeks after. They should not receive live vaccines or mRNA COVID vaccines within 7 days before or during treatment. Participants must also be willing to have surgical removal of the lesion site at the completion of the study.

Ongoing Clinical Trials on Polyinosinic:polycytidylic Acid

  • A study to evaluate the safety and effectiveness of BO-112 injections in patients with resectable primary basal cell carcinoma.

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Basal Cell Carcinoma (BCC): A type of skin cancer that begins in the basal cells, which are responsible for producing new skin cells. It's the most common form of skin cancer and usually develops on areas exposed to the sun.
  • Polyinosinic:polycytidylic Acid (BO-112): The investigational drug being studied in this trial. It's a solution for injection that may have potential effects against cancer cells when injected directly into tumors.
  • Intra-lesional (IL) injection: A method of administering medication directly into a lesion or tumor, rather than through the bloodstream or orally.
  • Resectable: Referring to a tumor or lesion that can be surgically removed.
  • Phase 2b trial: A stage of clinical research that further evaluates the effectiveness and safety of a drug in a larger group of patients, building on earlier phase studies.
  • Open-label: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Pathological response: The effect of treatment on cancer cells as observed under a microscope after the tumor is removed and examined.
  • Visual response: The visible changes in a tumor or lesion that can be observed by medical professionals during treatment.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it is caused by the treatment.
  • Recurrence rate: The frequency at which a disease or condition returns after treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-bo-112-for-patients-with-resectable-low-and-high-risk-basal-cell-carcinoma/