In a news release from January 24, 2022, immuno-pharma company AIM ImmunoTech Inc. (“AIM”) shared that positive clinical data was now published. The data, which you can find in Clinical Cancer Research, centers around a Phase 1/2 clinical trial evaluating intraperitoneal chemo-immunotherapy for advanced recurrent ovarian cancer. Altogether, the study found that combining Ampligen (rintatolimod) and interferon-alpha with chemotherapy (cisplatin/paclitaxel) could ultimately benefit patient outcomes.

The Study

Within this particular clinical trial, researchers sought to understand how rintatolimod could help increase tumor sensitivity to chemotherapy. Rintatolimod is a TLR3-agonist with various antiviral and immunomodulatory elements. It helps to increase natural killer (NK) cell function, as well as produce more interferons (like interferon-alpha) and immune cells. Through this, rintatolimod works to make ovarian tumors more sensitive to treatment, making combination therapies like chemo-immunotherapy more effective. Learn more about rintatolimod here.

Altogether, 12 participants enrolled in the Phase 1 part of this clinical trial. Researchers wanted to understand the safety, efficacy, and tolerability of chemo-immunotherapy. Additionally, during Phase 1, researchers sought to learn which dose should be used for further studies. Due to potential hypersensitivity or treatment issues, only 9 patients were able to complete 3+ cycles of Ampligen, chemotherapy, and celecoxib treatment. Findings include:

• The combination therapy was relatively safe and well-tolerated.
• Some adverse reactions did occur. These include joint pain, fatigue, low blood sodium levels, low blood magnesium levels, and anemia (low red blood cell count).
• Researchers believe that this treatment could improve overall survival rate (OSR), progression-free survival, and overall disease control. The median progression-free survival was around 8.4 months. Considering this type of cancer can be difficult to treat, this does show promise in improving patient outcomes.

Ovarian Cancer

As the name suggests, ovarian cancer forms in the ovaries: almond-shaped organs which store eggs and produce estrogen and progesterone. There are four forms of ovarian cancer: epithelial tumors (90% of diagnoses), germ cell carcinoma tumors (5% of diagnoses), stromal carcinoma tumors (5% of diagnoses), and small cell carcinoma of the ovary (0.1% of diagnoses). In Stage I ovarian cancer, the cancer is usually only in one or both ovaries. By Stage II it may spread to the bladder. In later stages, this cancer may metastasize throughout the body, including to the lungs, liver, and lymph nodes. The cause of ovarian cancer is unknown in many cases. However, BRCA1 or BRCA2 gene mutations may increase the risk of developing ovarian cancer. In fact, these mutations increase the risk by 10-30x. Symptoms may vary depending on cancer subtype, but can include:

• Abdominal pain and swelling
• Appetite loss
• Breast tenderness
• Bloating
• Increased testosterone and virilizing symptoms
• Abnormal vaginal secretions
• Menstrual irregularities
• Pelvic pain
• Changes in urinary urgency or frequency
• Abnormal uterine bleeding

Learn more about ovarian cancer.