Melbourne, Australia; 15 June, 2009: Patrys Limited (ASX: PAB) (the “Company”), Australia’s natural human antibody therapy company, announced today that it has completed preclinical safety studies for lead products PAT-LM1 and PAT-SM6.
Dosing under the studies commenced on 18 May 2009 and was completed on 2 June 2009. Each of PAT-LM1 and PAT-SM6 were tested independently.
There were no adverse reactions in any of the subjects. All of the testing was conducted by Maccine Pte Ltd., a Singaporean based contract research organisation.
The data generated provides Patrys with product safety information that is typically required to gain approval to commence human clinical trials for therapeutic products of this type. As a result, no further safety studies are currently planned before applying for such approval.
“To our knowledge, no other natural human antibodies being developed as treatments for cancer have been tested in preclinical safety studies of this nature. Accordingly, these results positively address a previously unknown development risk,” said Patrys Senior Director, Clinical Operations, Mr. Amos Hedt.
“The successful completion of these studies represents a significant milestone in advancing PAT-LM1 and PAT-SM6 to human clinical trials,” said Patrys CEO, Mr. Daniel Devine. “As these products have attributes shared by all the products in our deep pipeline, the results also have a positive impact on the value of the overall Company.”
The evaluation of non-safety related characteristics of each product’s behavior in the preclinical studies will continue through July 2009, at which time a further market announcement will be made. Assuming no unexpected issues arise upon the analysis of that data, it is expected to take an additional 8 to 10 weeks to apply for and receive approval to commence human trials.
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibodies as therapies for cancer and other major diseases. Patrys has a deep pipeline of anti-cancer natural human antibodies that enable both internal development and partnering opportunities. More information can be found at www.patrys.com.
About PAT-SM6:
The natural human antibody PAT-SM6 has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. PAT-SM6 acts by a novel mechanism to bring about the death of cancer cells, by binding to toxic LDL particles in the blood, and then importing that LDL into cancer cells via a proprietary cancer associated disease target that is expressed on the surface of cancer cells but not healthy tissues screened. As a result, lipid accumulates to toxic levels in the cancer cells and leads to death of the cells. Patrys has now screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type, age, gender or disease stage. Patrys has filed patent applications to cover the PAT-SM6 molecule, its disease target, and its mechanism of action.
About PAT-LM1:
PAT-LM1 is a natural human antibody that has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. This lead product binds to a proprietary disease target that is expressed on the surface of cancer cells, but not on the surface of the healthy tissues screened. With over 200 individual patient tumours screened, covering several different cancers, PAT-LM1 binds to nearly 98% of those tumours regardless of cancer type, age, gender or disease stage. Patrys has filed patent applications to cover the PAT-LM1 molecule and its disease target.
About Safety Studies:
Safety studies of the type conducted by Patrys are intended to determine what, if any, safety issues a given product may present in a human clinical trial setting. While Patrys’ lead products are fully human in composition and have displayed a very safe profile in animal studies to date, any product at this stage has the potential, however small, to create unexpected safety issues. In addition, while in many cases the results from such studies aid in predicting the safety profile of a product in a human clinical setting, as these studies involve non-human primates and/or other animals, they can not be relied upon to be completely predictive of what may happen in a human clinical setting.
Human Clinical Trials for PAT-LM1 and PAT-SM6:
All clinical trials for novel therapeutic products in Australia must be approved by an independent Human Research Ethics Committee (HREC). A standard timeframe from the commencement of review to the approval of the study is 8 to 10 weeks, although the actual timing is at the discretion of the HREC, which may request additional information or for more testing to take place.
