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FLORA-5 (NCT04498117, 2020-002270-26) -A Phase 3, Double- Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma.

Ovarian Cancer and Stages

Ovarian cancer is one of the most serious of women's cancer as the majority of women with ovarian cancer are diagnosed at an advanced stage of the disease. *According to American Cancer Society, thousands of women live with it in the US. According to the ACS, in 2021 about 21,400 will receive a new diagnosis and about 13,770 women will die from ovarian cancer. **Each year, roughly 239,000 new incident cases and 152,000 deaths worldwide occur due to ovarian cancer, with the highest rates reported in developed parts of the world. Innovations and research on immunological treatments are showing great promise. Oregovomab, an immunological treatment is currently in this phase 3 clinical trial (FLORA-5).

Stage 1

Stage I ovarian cancer is considered an early cancer. The cancer is confined to the ovary (or fallopian tube). This stage is divided into three substages, A, B, and C:
Stage IA: cancer cells are present in one ovary or fallopian tube.
Stage IB: cancer cells are present in both ovaries, or in both fallopian tubes.
Stage IC: cancer cells are present in one or both ovaries or fallopian tubes, and one of the following:

  • The outside of the ovaries or fallopian tubes has cancer cells;
  • The covering of the ovary, called the capsule, has broken open; or
  • Cancer cells are found in your peritoneal cavity, its tissue lining, or fluid from your abdomen.

Stage 2

Stage II cancer has begun to spread. Growth of the cancer involves one or both ovaries, with pelvic extension. This stage is divided into two substages, A and B:
Stage IIA: cancer has spread from the ovary or ovaries to the fallopian tubes and/or the uterus, or it has spread from the fallopian tubes to the ovaries and/or uterus.
Stage IIB: cancer has spread in the peritoneal cavity to your bladder, colon, or rectum.

Stage 3

Stage III cancer is more advanced. Growth of the cancer involves one or both ovaries, and the cancer has spread beyond pelvis. This stage is divided into three substages, A, B, and C:
Stage IIIA: microscopic cancer cells found in upper abdomen or lymph nodes.
Stage IIIB: visible tumor found in upper abdomen, less than 2 cm in size.
Stage IIIC: visible tumor found in upper abdomen, greater than 2 cm in size, including disease on surface of liver or spleen.

Stage 4

Stage IV cancer is the most advanced form of ovarian cancer. The cancer growth is widely spread throughout the body. There are two substages, A and B:
Stage IVA: cancer cells are found in extra fluid that has built up around the lungs.
Stage IVB: cancer has spread to organs and tissues outside the abdomen, including lymph nodes in the groin.

Ovarian Cancer Symptoms

If you have the following symptoms more than 12 times a month, see you doctor.

  • Bloating
  • Pelvic or abdominal (belly) pain
  • Trouble eating or feeling full quickly
  • Urinary symptoms such as urgency (constantly feeling like you have to go) or frequency (having to go often)

Other Symptoms

  • Fatigue (extreme tiredness)
  • Upset stomach
  • Back pain
  • Pain during sex
  • Constipation
  • Changes in a woman's period, such as heavier than normal or irregular bleeding
  • Abdominal (belly) swelling with weight loss

Our Approach - Oregovomab

Oregovomab, an investigational monoclonal antibody that is not yet approved by any regulatory authority in any country. Monoclonal antibodies are proteins made in the laboratory that can find and attach to receptors in the body, including cancer cells. Oregovomab binds to the CA-125 antigen (a substance that is produced by most ovarian cancers and can be found in the tumor and in the blood). Studies have shown that adding oregovomab after taking chemotherapy (paclitaxel and carboplatin) may potentially extend the overall survival with very few side effects.