Patrys Announces Initiation of Safety Studies for Lead Products PAT-LM1 and PAT-SM6
Melbourne, Australia; 25 May, 2009: Patrys Limited (ASX: PAB), Australia’s natural human antibody therapy company, advises that it has initiated preclinical safety studies for lead products PAT-LM1 and PAT-SM6.
PAT-LM1 and PAT-SM6 are each natural human antibody products that have shown potential across a number of cancer applications.
The preclinical safety studies, which are expected to last approximately one month, are being conducted at Maccine Pte Ltd, a Singapore based contract research organisation. Following conclusion of the studies, it is anticipated that a further period of up to two months may be required to evaluate the results of the trial. These studies have commenced after a delay due to capacity reductions at the Company’s contract manufacturing organisation that were announced to the market in December 2008.
The safety studies being conducted by Patrys have been designed to generate information that is typically required prior to obtaining approval to test a therapeutic product candidate in human clinical trials.
The advancement of PAT-LM1 and PAT-SM6 to preclinical safety studies also means that Patrys has achieved its production goals at this stage in the products’ development. In the first instance, the quality standards met by the products selected for these preclinical safety studies are similar to the typical standards that have to be met to advance products of this type to human clinical trials. In addition, the productivity of the system, meaning yield, is expected to be sufficient to support the further development and commercialisation of the products.
“Historically, the production of antibodies naturally made by the human body to fight cancer has proven very difficult in terms of producing material of sufficient quality and at sufficient yields to support advanced development as therapeutics,” said Patrys Vice President, Manufacturing, Michael Conner. “The Patrys’ team considers the achievement of this milestone a significant step in the ongoing development of our pipeline.” www.patrys.com/mediareleases/66-Patry...