Recruiting Ovarian Cancer Patients for Phase 3 Trial of Innovative Virus Therapy

Oncolytic Virus Olvi-Vec Shows Promise in Ovarian Cancer Treatment, Phase 3 Trial Underway

New York, NY – A modified virus, Olvi-Vec, is demonstrating important potential as a novel treatment for recurrent ovarian cancer, including fallopian tube and primary peritoneal cancers, resistant to standard platinum chemotherapy. Developed by Genelux, Olvi-Vec leverages a modified vaccinia virus – the basis for the smallpox vaccine – engineered to selectively target and destroy cancer cells while leaving healthy tissue unharmed.

A pivotal Phase 3 clinical trial, OnPrime/GOG-3076 (NCT05281471), is currently enrolling approximately 186 patients across 31 U.S. sites. Participants, who have previously undergone at least three lines of therapy, will receive their physician’s preferred chemotherapy regimen alongside the approved drug bevacizumab (Avastin). A subset of patients will also receive Olvi-Vec directly into the abdominal cavity. The trial’s primary objective is to determine if adding Olvi-vec extends the time before disease progression or death by up to a year.The therapy employs a “one-two punch” approach. Initially, the virus directly kills tumor cells. This destruction triggers an immune response, alerting the body’s natural defenses. olvi-Vec is designed to capitalize on this activation,guiding the immune system to further attack and eliminate remaining cancer cells.

Earlier Phase 2 data from the VIRO-15 (NCT02759588) study revealed Olvi-Vec was both safe and effective in patients with platinum-resistant ovarian cancer, even those who had exhausted multiple treatment options. The localized abdominal delivery proved prosperous in destroying cancer cells, stimulating the immune system, and, in some instances, restoring sensitivity to platinum-based chemotherapy.

“With critically important data milestones on the horizon, Olvi-Vec holds the potential to redefine the treatment paradigms of recurrent tumors,” stated Thomas Zindrick, Chairman, President, and CEO of Genelux.

Genelux is also actively investigating Olvi-Vec’s efficacy against specific types of lung cancer through ongoing clinical trials. The company anticipates entering a period of significant growth as it advances this potentially transformative therapy for patients facing limited treatment alternatives.

What assessments will be used to determine my ovarian reserve and how might this impact my eligibility?

Understanding the Trial: A New Approach to Ovarian Cancer Treatment

We are actively recruiting patients for a Phase 3 clinical trial investigating a novel oncolytic virus therapy for advanced ovarian cancer. This trial represents a meaningful step forward in exploring innovative treatment options beyond conventional chemotherapy and surgery. This therapy utilizes a specifically engineered virus to selectively target and destroy cancer cells while sparing healthy tissue. This approach, known as oncolytic virotherapy, is showing promising results in early-stage trials for various cancers, and we are excited to evaluate its efficacy in a larger cohort of ovarian cancer patients.

Who is Eligible for the Ovarian Cancer Trial?

Determining eligibility is crucial for ensuring both patient safety and the integrity of the trial data. Here’s a breakdown of the key inclusion and exclusion criteria:

Diagnosis: Confirmed diagnosis of high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

stage: Patients must have Stage III or IV disease.

Prior Treatment: Patients must have progressed on at least one prior line of platinum-based chemotherapy.

Performance Status: ECOG performance status of 0 or 1 (generally good health with some limitations).

Ovarian Reserve: As ovarian reserve and fertility decline with age, and can impact treatment outcomes, we assess this factor. (See: Ovary – Wikipedia).

Organ Function: Adequate kidney, liver, and bone marrow function.

Exclusion Criteria:

Prior treatment with other oncolytic viruses.

Active autoimmune disease requiring immunosuppression.

Significant uncontrolled co-morbidities.

Pregnancy or breastfeeding.

The science Behind Oncolytic Virus Therapy for Ovarian Cancer

Oncolytic viruses are engineered to specifically infect and replicate within cancer cells, leading to their destruction. Several mechanisms contribute to this anti-cancer effect:

1. Direct Lysis: The virus directly kills cancer cells as it replicates.
2. Immune Stimulation: Viral infection triggers an immune response, activating the body’s own defenses against the cancer. This includes increased T-cell activity and cytokine release.
3. Vascular Disruption: The virus can disrupt the blood supply to the tumor, further inhibiting its growth.
4. Selective Targeting: The engineered virus is designed to target receptors commonly found on ovarian cancer cells, minimizing harm to healthy tissues.

This therapy differs substantially from traditional chemotherapy, wich often affects rapidly dividing cells throughout the body, leading to significant side effects.

What to Expect During the Phase 3 Trial

The trial is designed as a randomized, controlled study. Participants will be randomly assigned to receive either the oncolytic virus therapy in combination with standard-of-care treatment or standard-of-care treatment alone.

Here’s a general overview of the trial process:

1. Screening: A thorough evaluation to determine eligibility, including medical history, physical exam, blood tests, and imaging scans (CT, MRI).
2. Baseline Assessments: Detailed assessments of tumor size, performance status, and quality of life.
3. Treatment Phase: Participants will receive treatment according to their assigned arm of the study. The virus therapy will be administered intravenously.
4. Follow-up: Regular monitoring of tumor response, side effects, and overall health. Follow-up will continue for an extended period after treatment completion.
5. Data Collection: Throughout the trial,data will be collected on treatment response,safety,and quality of life. This data will be used to evaluate the efficacy and safety of the virus therapy.

Potential Benefits and Risks

Potential Benefits:

Improved Progression-Free Survival: The primary goal of the trial is to demonstrate whether the virus therapy can extend the time before the cancer starts to grow again.

Overall Survival Benefit: We also aim to determine if the therapy can improve overall survival.

Enhanced Immune Response: The virus therapy may stimulate the immune system to fight the cancer more effectively.

Reduced Side Effects: Compared to traditional chemotherapy, the virus therapy may have a more favorable side effect profile.

Potential Risks:

Infusion-Related reactions: Some patients may experience mild to moderate reactions during the intravenous infusion of the virus therapy, such as fever, chills, or fatigue.

Flu-like Symptoms: The virus may cause mild flu-like symptoms as the immune system responds.

Off-Target Effects: Although the virus is engineered to target cancer cells, there is a potential for it to infect healthy tissues.

Unknown Long-term Effects: as with any new therapy, the long-term effects of the virus therapy are not fully known.

All potential risks will be thoroughly discussed with participants during the informed consent process.

How to Learn More and Participate

If you or a loved one has been diagnosed with advanced ovarian cancer and meets the eligibility criteria, we encourage you to learn more about this clinical trial.

Contact Facts: Please contact our clinical trial team at [Insert Phone Number] or [Insert Email address].

Website: Visit our website at [Insert Website Address] for more detailed information about the trial, including the study protocol and frequently asked questions.

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