AustCancer in pancreatic cancer agreement

Australian Cancer Technology (AustCancer) has signed an agreement with the German company RESprotect, to acquire the North American licence to a developmental pancreatic cancer drug.

The drug, RP101, has demonstrated promising results in a clinical Phase I/II pilot study. AustCancer has developed an accelerated clinical trial program for RP101 which would include application to the US FDA for Orphan Drug status.

RP101 is targeted at preventing cells from developing a resistance to chemotherapy, one of the most challenging areas facing oncologists. RP101 would be used as a co-treatment with cytostatic drugs to give a broader range of chemotherapy treatment options, thereby extending survival periods and improving quality of life for the cancer patients.

A Phase I/II pilot clinical study with 30 patients in German clinics over five tumour types (metastasised breast, metastasised ovarian, non small cell lung cancer, small cell lung cancer and metastasised pancreatic cancer) was completed in 2003 with different chemotherapy agents. An enlargement of the pilot trial, in 13 metastasised pancreatic cancer patients is still running.

An interim analysis of this trial shows strong patient responses, including total remission in two patients as measured by tumour markers, and partial remission of the primary tumour in three patients as measured by computerised tomography or sonography. Moreover, in two other patients, remissions of liver or lung metastases could be observed. According to the interim analysis, it seems likely that RP101 co-treatment significantly enhances survival time, remissions, time to progression and response to chemotherapy.

RESprotect's founder and major shareholder, geneticist Professor Dr. Rudolf Fahrig commented that: 'the results from the Phase I/II pilot trials are extremely promising and show particular efficacy in pancreatic cancer patients. This is probably due to the fact that when tested in vitro with tumour cells, RP101 has a major effect in down-regulating the oncogene STAT3, and the DNA-repair gene APEX, which are over-expressed in pancreatic carcinoma.'

AustCancer's Chairman, Dr Roger Aston said: 'While the patient numbers in the previous pancreatic trials were small, the results appear significant. We believe that the drug may offer new or significant improvements for pancreatic cancer by satisfying unmet medical needs, and therefore might qualify for Orphan Drug status when we lodge the IND (Investigative New Drug application) in the US next year.'

A repeat Phase I/II dose finding study is expected to begin in Germany in the autumn of 2004 and will be funded by AustCancer. The trial will be over two centres with 22 pancreatic patients and managed by a Swiss CRO. Following the results of this trial, which is expected to last six months, AustCancer will commence a pivotal Phase IIb/III trial in the US in 2005 and has already held discussions with two leading US cancer centres who are interested in running the trial. AustCancer has commenced the regulatory due diligence in the US and expects to lodge a submission with the FDA next year.

Pancreatic cancer

Cancer of the pancreas is the fifth leading cause of cancer deaths with mean survival time for locally metastasised pancreatic cancer of 4-6 months with a 2-year survival rate of 10%. There are approximately 20,000 new pancreatic cancer patients in the US each year.