Antisense Therapeutics Limited (/exchange>PINKSHEETS/exchange>>/>: ATHJY) (/exchange>ASX/exchange>>/>: ANP) is pleased to announce that the Company has now completed repeat-dosing toxicology studies for ATL1103 in two species -- mouse and non-human primate. Draft study reports from the study contractors in the United States have been received, and the toxicology outcomes from these studies support ANP's plans for the continued development of ATL1103.
ATL1103 is a second-generation antisense drug that targets the growth hormone receptor (GHR). By blocking the action of GHR, ATL1103 inhibits production of insulin-like growth factor -1 (IGF-I) from the liver thereby reducing its levels in the blood. GHR is a clinically validated therapeutic target in the growth disorder acromegaly (excessive growth of parts of the body and organs including the liver, kidney and heart) where the goal of treatment is to normalise IGF-1 levels in the blood. There is a clear need for better treatments for this niche and difficult to treat disease with the size of this market nearing US$1Billion per annum in drug sales.
In addition, treatments that reduce IGF-I levels in the blood (e.g. irradiation of the pituitary gland), have shown clinical benefit in the treatment of the disease diabetic retinopathy, a complication associated with diabetes where new blood vessels are formed in the eye with the potential to cause blindness. There is presently no pharmaceutical therapeutic approved for the treatment of vision impairment in the advanced stage of diabetic retinopathy. Consequently an effective treatment for this disease could secure a major position in this potentially multi-billion dollar market.
In animal study results previously reported by the Company, ATL1103 demonstrated its intended therapeutic action by significantly reducing IGF-I levels in the blood. ATL1103 has also demonstrated its intended therapeutic action in an animal model of retinopathy by significantly reducing retinal neovascularisation (formation of new blood vessels).
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."