The repeat toxicology dosing studies in two species over several months are the major component of the ATL1103 toxicology program. The Company anticipates that the two remaining short term or acute studies, referred to as Safety Pharmacology and Genotoxicity, are to be completed by end of this year, after which it intends to be in a position to submit an application for a human clinical trial in the first half of 2010.
ANP's existing major shareholder and technology partner, Isis Pharmaceuticals Inc are now to complete the characterisation and release of the cGMP drug substance for formulation of the clinical supplies to be used in the planned future clinical trial. Isis will also prepare the drug substance CMC (Chemistry, Manufacturing and Controls) documentation for inclusion in the clinical trial application. Isis are undertaking this additional work in return for 18.475 million new ordinary shares in ANP. These shares will be placed in escrow for twelve months.
"We are very pleased to see another one of our satellite company partners progress another antisense drug towards the clinic," said C. Frank Bennett, Senior Vice President of Research of Isis Pharmaceuticals. "In ANP's case, this follows their lead compound ATL1102 which demonstrated successful Phase II results in patients with relapsing remitting MS. Similarly we are excited about the potential of ATL1103 to treat and improve the quality of life in patients suffering from difficult to treat diseases."
SOURCE: Antisense