Peplin obtains positive anti-leukemia results for drug candidate in mouse model

Peplin (ASX:PEP) has produced positive results from an initial efficacy study of its drug candidate PEP005 IV in a mouse model of acute myeloid leukemia.

"This is a very important piece in the jigsaw. We have shown we can test human leukemias in vitro and in this study we have demonstrated we can treat human leukemias in mammals," said Peplin managing director and CEO Michael Aldridge.

"The conclusions of the study were a positive impact on the survival and a dramatic impact on tumour burden in the most relevant model for this disease.

"We are now on track to file an investigational new drug (IND) application with the US FDA in the first quarter of 2006. These sorts of results also facilitate access to international clinical centres," said Aldridge.

In the pilot two-group study conducted at a European institution, either PEP005 IV (active group) or vehicle (control group) was delivered daily intravenously for five days to five mice in each group. The mice had a human form of acute myeloid leukemia (AML) engrafted into their blood system.

"It's a devastating form of leukemia with a five-year survival rate of less than 20 per cent. There are very few therapeutic options for the disease and we are vigorously pursuing the opportunity to bring this product to market and benefit patients with this sort of leukemia," he said.

The study evaluated two endpoints -- the first was PEP005 IV's impact on survival. It had a positive impact on the survival of mice in the PEP005 IV-treated group; however, in the small number of mice, the difference was not statistically significant.

The second endpoint evaluated was PEP005 IV's impact on tumour burden in various organs. There was a reduction in tumour burden in abdominal lymph nodes of the PEP005 IV-treated group compared with the vehicle group and this difference was statistically significant (P = 0.0007). In addition, there was a positive impact on tumour burden in bone marrow and blood.

Peplin expects to complete pre-clinical studies of PEP005 in this mouse model using a larger treatment group before the end of 2005.

GMP facility

Peplin has commenced construction of a new commercial scale and manufacturing facility for the production of GMP grade PEP005.

The new facility will consolidate Peplin's current validated extraction and GMP purification technologies, which it has previously operated in two separate facilities. In addition, Peplin will implement selected process improvements to optimise productivity. The new facility will provide the company with sufficient PEP005 in the future to supply a global market.

Peplin expects to complete the commissioning of the facility and secure a GMP manufacturing licence in 2006.