Progen begins phase II PI-88 trial in Taiwan

Brisbane oncology drug developer Progen Industries (ASX:PGL, NASDAQ:PGLAF) today announced it has begun the fourth and largest Phase II clinical trial of its lead anti-cancer drug PI-88 in patients who have undergone surgery for primary liver cancer.

The trial will be the first to test PI-88’s performance as an adjuvant therapy to prevent or reduce the development of secondary, metastatic tumours, a common occurrence in the 12 months after surgery to remove primary liver cancer.

Progen’s said the trial, involving 340 volunteer patients, will be conducted in collaboration with Taiwanese company Medigen Biotechnology Corporation. It will involve four major hospitals in Taiwan.

PI-88 inhibits angiogenesis, the proliferation of blood vessels that fuel the rapid growth of secondary tumours.

Progen managing director Lewis Lee said that to determine the efficacy of an angiogenesis inhibitor like PI-88 would normally involve a huge investment, and many years of research. Such an approach was neither practical nor desirable, and it reduced the patent life of the drug if it proved successful.

“The current trial design and target disease represents a very sensible and practical opportunity to assess PI-88’s potential to improve cancer patient survival after tumour bulk has been removed,” Lee said.

The Taiwan trial will determine the number of patients who suffer a recurrence of cancer in the 48 weeks after surgery for primary liver cancer- the first patient was due to be treated today.

The company says that in previous Phase II trials, PI-88 had demonstrated benefit and an impact on disease recurrence in some cancer patients.

In a Phase II trial in the US which ended in January this year, more than 40 per cent of patients with metastatic melanoma showed retarded growth of secondary tumours for up to 35 months after being given PI-88 as a stand-alone therapy.

In another trial that ended last August, 41 per cent of patients with multiple myeloma showed cancer stabilisation for periods of up to two years.

PI-88 is being trialled as part on an Investigational New Drug application in the US, Australia and Taiwan. It has also been trialled in patients with non-small cell lung cancer.

Half a million new cases of primary liver cancer, or hepatocellular carcinoma, are diagnosed worldwide every year. It is the fifth most common of all cancers, and often results from cirrhosis of the liver, a consequence of chronic Hepatitis B virus (HBV) or Hepatitis C virus (HCV) virus infections.

Hepatocellular carcinoma is more common in Asia than in western nations, and is primarily due to HBV infection.

It is the most common of all cancers in Taiwan, where problems with early diagnosis mean that only 10 to 20 per cent of cases are operable – inoperable liver cancer is typically fatal within 3 to 6 months.