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Litenimod Sodium

A new clinical trial is investigating the use of Litenimod Sodium, a promising drug, in combination with peptide vaccines for the treatment of glioblastoma, an aggressive form of brain cancer. This Phase 1/2a study, known as NAVIG-1, aims to evaluate the safety, efficacy, and immune responses triggered by this innovative approach in patients who have already undergone initial standard treatment.

Table of Contents

What is LITENIMOD SODIUM?

LITENIMOD SODIUM is an investigational drug being studied for the treatment of glioblastoma, a type of aggressive brain cancer[1]. It belongs to a class of medications called cytokines and immunomodulators, which are substances that can modify or regulate the immune system’s function[1].

The drug is currently being tested in a clinical trial called NAVIG-1, which stands for “New adjuvant vaccine in glioblastoma.” This trial is exploring the use of LITENIMOD SODIUM in combination with other treatments for patients with glioblastoma[1].

How is LITENIMOD SODIUM Used?

In the clinical trial, LITENIMOD SODIUM is administered as a solution for injection. The drug is given through subcutaneous injections, which means it’s injected just under the skin, typically in the shoulder area[1].

The trial is testing LITENIMOD SODIUM in combination with other treatments, including:

  • Peptides (small proteins) that may help stimulate the immune system
  • Temozolomide, a chemotherapy drug commonly used for glioblastoma
  • Radiation therapy

Clinical Trial Details

The NAVIG-1 trial is a Phase 1/2a study, which means it’s an early-stage trial designed to test the safety and effectiveness of the treatment[1]. The trial has two main parts:

  1. Phase 1: This phase aims to determine the safest and most effective dose of the treatment. Researchers will test different dose levels of the peptides (50, 100, or 250 micrograms) combined with a fixed dose of 1mg of LITENIMOD SODIUM[1].
  2. Phase 2a: In this phase, researchers will use the dose selected in Phase 1 to further study the treatment’s effectiveness and safety[1].

Eligibility Criteria

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

  • Age between 18 and 75 years old
  • Confirmed diagnosis of glioblastoma
  • Previous treatment with radiation therapy and temozolomide
  • Adequate organ function
  • Specific genetic markers (HLA-A2 positive and PTPRZ1 expression in the tumor)[1]

There are also several factors that may exclude a patient from participating, such as certain medical conditions, pregnancy, or recent use of other experimental treatments[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider:

Potential Benefits:

  • Improved survival rates for glioblastoma patients
  • Potential to slow or stop tumor growth
  • Contribution to scientific knowledge about glioblastoma treatment

Potential Risks:

  • Side effects from the treatment, which may range from mild to severe
  • Possibility that the treatment may not be effective
  • Time commitment and potential discomfort from trial procedures

What to Expect During the Trial

Participants in the NAVIG-1 trial can expect the following:

  • Regular medical check-ups and blood tests to monitor safety and immune responses[1]
  • Brain MRI scans to assess tumor progression[1]
  • Quality of life assessments using questionnaires[1]
  • Treatment administration through subcutaneous injections
  • Long-term follow-up to assess overall survival and long-term effects of the treatment

It’s important to note that participation in clinical trials is voluntary, and patients can withdraw at any time. If you’re interested in learning more about this trial or other treatment options for glioblastoma, it’s crucial to discuss with your healthcare provider to determine the best course of action for your individual situation.

Aspect Details
Study Name NAVIG-1: New adjuvant vaccine in glioblastoma, Phase 1/2a study
Drug Litenimod Sodium (solution for injection)
Administration Subcutaneous injections in shoulders
Phase 1 Objective Assess maximum tolerated dose and select recommended Phase 2a dose
Phase 2a Objective Assess anti-PTPRZ1/TERT specific T cell responses at 2 months
Key Eligibility Adults 18-75, confirmed glioblastoma, HLA-A2 positive, prior standard treatment
Primary Endpoints Safety (Phase 1), Immune efficacy (Phase 2a)
Secondary Endpoints Immune responses, long-term safety, progression-free survival, overall survival, quality of life

FAQ

  • What is Litenimod Sodium? Litenimod Sodium is a drug being studied as part of a new treatment approach for glioblastoma. It belongs to a class of drugs called cytokines and immunomodulators, which means it may help boost the body's immune response against cancer cells.
  • How is Litenimod Sodium administered in this trial? In this trial, Litenimod Sodium is given as a subcutaneous injection (under the skin) in the shoulders. It is administered along with peptide vaccines at different dose levels to find the best dose for treatment.
  • Who is eligible for this clinical trial? The trial is open to adults aged 18-75 with confirmed glioblastoma who have already received standard initial treatment including radiation therapy and chemotherapy. Participants must also meet specific criteria, such as being HLA-A2 positive and having adequate organ function.
  • What are the main goals of this clinical trial? The main goals are to determine the safe dose of the treatment (Phase 1) and to assess the immune responses it triggers against specific proteins found in glioblastoma cells (Phase 2a). The study will also look at how well the treatment works and how it affects patients' quality of life.
  • How long does the trial last? The trial involves multiple visits over at least 12 months. Participants will have regular check-ups, blood tests, and brain scans to monitor their progress and any side effects of the treatment.

Ongoing Clinical Trials on Litenimod Sodium

  • Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Glioblastoma: An aggressive type of cancer that occurs in the brain or spinal cord.
  • Litenimod Sodium: An investigational drug being studied for its potential to boost the immune system's response against cancer cells.
  • Subcutaneous injection: A method of giving medication by injecting it under the skin.
  • HLA-A2: A specific type of human leukocyte antigen (HLA) that plays a role in the body's immune response.
  • PTPRZ1: A protein found in some glioblastoma tumors that is targeted by the experimental treatment in this study.
  • TERT: Another protein targeted by the experimental treatment, which is often found in cancer cells.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Progression-free survival: The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival: The length of time from the start of treatment that patients diagnosed with the disease are still alive.
  • ELISPOT: A laboratory test used to measure immune responses by detecting cells that produce specific proteins.
  • Karnofsky Performance Status: A scale used to measure a patient's ability to perform ordinary tasks and their general well-being.
  • RANO 2.0 criteria: A set of guidelines used to assess how brain tumors respond to treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-a49-a52-and-litenimod-sodium-for-patients-with-glioblastoma/