Positive Results For Liver Cancer Trial

Main Category: Cancer / Oncology
Also Included In: Liver Disease / Hepatitis;  Clinical Trials / Drug Trials
Article Date: 24 Dec 2006 - 0:00 PDT

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Liver cancer (or hepatocellular cancer) is the fourth most common cancer in the world and one of the most deadly, killing most patients within a year. [1] In Australia in 2002 1.3% of all male deaths were due to liver disease in (AIHW National Morbidity Database, Australia's Health 2004, AIHW).

Most cases of liver cancer are caused by hepatitis infection (usually hepatitis B or C) or cirrhosis (alcoholism being the most common cause of hepatic cirrhosis). In countries where hepatitis is not endemic, most malignant cancers in the liver are not primary liver cancer but metastasis (spread) of cancer from elsewhere in the body, e.g. the colon. Treatment options of liver cancer and prognosis are dependent on many factors but especially on tumor size and staging.

Progen Industries (ASX: PGL; Nasdaq: PGLA) today announced positive preliminary results from its Phase II clinical trial of PI-88 for the treatment of patients with primary liver cancer following surgical resection of the tumour. The trial demonstrated that PI-88 increased time to tumour recurrence by 76%.

The patient group treated with 160 mg of PI-88 had a substantial delay in tumour recurrence compared to those not receiving PI-88 (30 weeks compared with 17 weeks).

"These results are clinically very encouraging. It's hard to overstate the importance to the patient's quality of life of each day that they remain free of liver cancer. It is well known that once liver cancer recurs, the patient's survival prognosis is poor and the quality of life deteriorates dramatically," said Professor John Zalcberg, Chief Clinical Advisor to and Non-executive Director of Progen.

Justus Homburg, Chief Executive Officer of Progen stated, "We conducted this preliminary data analysis of all 168 evaluable patients at the 30-week time point to assist us now with a timely Phase 3 trial design. These results offer excellent support as we proceed to Phase 3 development, with the guidance of the FDA, as rapidly as possible. These 30-week data will not change and will be expanded upon as final 48 week data are analysed."

The final data for this Phase 2 trial (at 48 weeks -- comprising 36 weeks of treatment and a 12-week follow-up period) are expected to be available by the second quarter of 2007, once the final data from all trial sites have been checked, processed and statistically analysed. The trial is being conducted at six sites in Taiwan.

Progen is now preparing for much larger Phase III trial of PI-88 for the treatment of liver cancer which will include sites in the US, Taiwan, Singapore, China, Hong Kong and South Korea.

Dr Chris Parish, PI-88 founding scientist from the Australian National University commented, "I am thrilled to see such strong clinical data on a product that I have spent many years studying. This demonstrates that the early discoveries we made in collaboration with Progen are now translating into benefits for cancer patients."

"The treatment of patients in a post-resection liver cancer setting is a very good match for the biological mechanism of action of PI-88. We know that even though the patient has surgery to remove the tumour there are still small tumours present. PI-88 works via a process called angiogenesis or the inhibition of growth of new blood vessels to these tumours and also on the spread of tumours, or metastatis. It is by this dual mechanism of action that we believe PI-88 has the potential to be any exciting alternative to current cancer treatments."

Progen Industries Ltd
http://www.progen.com.au/