LIPAC, a subsidiary of TesoRx, is developing a new Liposomal Enhanced Intraperitoneal Chemotherapy (LEIPC) for the intraperitoneal treatment of Stage II/III ovarian cancer and intraperitoneal cancer. It utilizes PLIP technology to improve penetration and enhance tolerability and could result in improved overall survival rates. LEIPC is instilled intraperitoneal every three weeks and is likely to be better tolerated than non-LEIPC treatments. The treatment is administered from a closed package system that doesn’t require any special preparation.

Common disease

In the U.S., ovarian cancer is the fifth-most common cancer in women and has the highest mortality rate of all gynecological cancers. In 2014, 21,980 new cases were diagnosed in the U.S. and 65,697 were diagnosed in the EU, of which 90 percent were epithelial ovarian cancers (EOCs) that have a five-year survival rate of 44 percent.

Significant unmet medical needs

The standard of care for ovarian cancer has remained largely unchanged since the 1970s. Chemotherapy is used after surgery to treat any residual disease, or before surgery when a tumor cannot be completely removed or optimally debulked via surgery. Despite optimal surgery and adjuvant paclitaxel-carboplatin chemotherapy, 70 percent of patients relapse within the first three years.

Chemotherapy can be given intravenously or in the peritoneal cavity. Intraperitoneal delivery enhances drug delivery at peritoneal surface and improves overall survival from 49.7 to 65.6 months by eliminating microscopic peritoneal disease more efficiently and delivering a much higher dose of the active drug. Efficacy of the relevant chemotherapy can be increased by heating the solution and administering the procedure via Hyperthermic Intraperitoneal Enhanced Chemotherapy (HIPEC).

Current chemotherapies used for intraperitoneal treatment have not been optimized nor approved for intravesical use. Common therapies can include paclitaxel, cisplatin, topotecan, doxorubicin, epirubicin, and gemcitabine.

Though existing intraperitoneal chemotherapy is associated with longer progression-free survival and overall survival, it is very invasive, causes more adverse side effects and toxicity than intravenous chemotherapy and practitioners have limited technical expertise with HIPEC. Further obstacles include two hours of additional time in the operating room, longer duration of hospitalization and increased use of diverting colostomies or ileostomies that increase the overall cost of treatment and reduce the overall quality of life.