Trovagene’s PCM-075 therapy for several blood cancers and solid tumors, including colon cancer, proved safe in a Phase 1 clinical trial.
The results of the trail conducted by Nerviano Medical Sciences will be submitted for publication soon.
PCM-075 inhibits the polo-like kinase 1 (PLK1) protein, which contributes to the development of certain types of cancer.
The trial (NCT01014429) assessed the safety of PCM-075 in 21 patients whose mean age was 62.7 years old. The group had advanced or metastatic solid tumors, including colon, pancreatic, lung, and head and neck cancer.
Patients received increasing doses of PCM-075 once a day for five consecutive days, in 21-day cycles. Treatment was administered until patients’ disease progressed or they experienced unacceptable toxicity.
Researchers then investigated several safety parameters, such as the body’s ability to absorb the drug, the dose at which it became toxic, and the maximum tolerated dose.
The team also investigated PCM-075’s pharmacokinetics, or how it behaves in a tumor or the blood, as well as its anticancer activity and its ability to target PLK1 in tissue biopsies.
PCM-075 was well-tolerated. The most common side effects were thrombocytopenia, or an abnormally low number of blood platelets, and neutropenia, a blood disorder characterized by an abnormally low number of neutrophils, a type of white blood cell. The side effects were consistent with the drug’s mechanism of action, researchers said.
“Hematologic [blood-related] side effects are expected with PLK inhibitors, which induce [cell division] arrest preferentially in rapidly proliferating blood cells, leading to cell death,” Mark Erlander, Trovagene’s chief scientific officer, said in a news release. “This suggests anti-tumor activity in hematologic malignancies and supports our plans to develop PCM-075 for the treatment of [acute myeloid leukemia].
“We believe the Phase 1 data indicates broad applications for PCM-075 in hematologic malignancies and solid tumors and we plan to continue to assess, and explore, additional precision cancer therapeutic opportunities going forward,” he added.
Colon cancer tumors develop in the inner wall of the colon. The most common type of colon cancer is colorectal cancer.
There will be more than 95,500 new cases of colon cancer in the United States in 2017, according to the American Cancer Society.