SYDNEY, Australia ¿ With a Phase II trial of a treatment for advanced skin cancer under way in the U.S., Progen Industries Ltd. in Brisbane is starting a Phase II trial using the same molecule as a treatment for a form of bone marrow cancer.
Progen said it is set to start the Phase II trials on 50 to 100 patients in several centers around Australia, including the Alfred Hospital in Melbourne, using its anticancer drug PI-88 following promising animal model results for human acute promyelocytic leukemia.
The animal model results are a surprise for PI-88 as previously Progen had been concentrating on developing the molecule for solid-tumor cancers.
Progen has previously established that in animal models PI-88 acts by inhibiting the action of the enzyme heparanase, involved in the spread of tumors to secondary sites (metastasis). In addition, PI-88 hindered the development of new blood vessels and so reduced the flow of blood to the tumor.
Peter Devine, vice president of business development for Progen, said company researchers led by Vice President of Research Rob Don, had decided do clinical trials for skin cancer first, since in that disease the tumors were directly accessible so researches could easily take tissue samples and clearly see the treatment effect.
Devine said that four patients had been recruited for the skin cancer trials being conducted at the Colorado University Health Sciences Center in Denver, and another three were being screened.
But while the skin cancer trial was being started, Progen researchers announced the results of a study conducted by Haakon Beenestad at the University of Oslo in Norway, which is to be published in the scientific journal Leukemia. Devine said that the results showed a significant decrease in the tumor cell counts in both animal models.
As a result the company had decided to start Phase II clinical trials for PI-88 as a treatment for multiple myeloma, the second most common form of hematological cancer and identified by the proliferation of plasma cells in the bond marrow.
The multiple myeloma trials are expected to start before Christmas and take about 18 months.