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May 02, 2013 -- Antisense Therapeutics Limited (“ANP” or “the Company”) is pleased to advise that an agreement has now been executed with Pharmaron, an internationally recognized Contract Research Organisation (CRO) in China, for the conduct of the chronic (6 month) toxicology study to support a potential future Phase IIb study of ATL1102 in multiple sclerosis (MS) patients.
Supplies of ATL1102 drug product for use in the toxicology study have been received by the CRO. The next step is the screening of primates for their suitability for inclusion into the study. This screening process will be overseen by ANP’s expert toxicology consultants and is expected to be finished in time for dosing to commence by the end of May 2013 and to be completed by the end of the year. Results from this toxicology study are anticipated early 2014, and if successful outcomes are achieved, ANP will commence planning for a Phase IIb study in MS patients.
ANP has managed to significantly reduce the costs for undertaking this chronic toxicology study and will fund the study out of its existing cash reserves. Any further development of ATL1102 would most likely be undertaken with a development and funding partner.
ANP recently announced the granting of a new US patent on ATL1102 for the treatment of relapsing- remitting multiple sclerosis (RR-MS) taking its patent life to 2029 and potentially extendible to 2034. This patent extension adds significant commercial value to ATL1102 against a backdrop of recent licensing deals in the multiple sclerosis space and including Biogen Idec’s purchase of Elan’s stake in Tysabri® (monoclonal antibody drug to VLA-4 – same target as ATL1102) for US$3.2 Billion.
The current annual sales of MS drug therapies are in excess of US$12 Billion. ATL1102 continues to profile as a commercially attractive drug for the treatment of MS; potentially as potent as Tysabri® (currently regarded as the most effective treatment for RR-MS and with annual sales of US$1.6 Billion/annum) but potentially safer, cheaper and more conveniently administered.
Following a successful Phase IIa trial conducted by ANP, ATL1102 was then tested, amongst other studies, in a chronic primate toxicology study conducted by Teva Pharmaceuticals Inc (Teva), ANP’s licensing partner at the time. An unexpected adverse finding was noted in that study that in Teva’s view required a repeat of the study. ANP and its expert advisors believe that this adverse finding may not present again at the doses that are to be tested in this new toxicology study and that are likely to be used in a Phase IIb trial, and therefore ANP believe it is worth undertaking the study due to the potential value that can be derived from a successful result.
ATL1102 represents an important and valuable asset to ANP and its further development is anticipated to build on that value and make it very attractive to a range of potential commercial suitors.
Background Information
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialise second generation antisense pharmaceuticals for large unmet markets. ANP has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals Inc., world leaders in antisense drug development and commercialisation - ATL1102 (injection) which has successfully completed a Phase II efficacy and safety trial, significantly reducing the number of brain lesions in patients with multiple sclerosis (MS), ATL1103 a second-generation antisense drug designed to block GHr production and thereby lower blood IGF-I levels and is in clinical development as a potential treatment for growth and other GH-IGF-I disorders, ATL1102 (inhaled) which is at the pre-clinical research stage as a potential treatment for asthma and ATL1101 a second-generation antisense drug at the pre-clinical stage being investigated as a potential treatment for cancer.
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4). In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the Central Nervous System (CNS) in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby slowing progression of the disease. VLA-4 is a clinically validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS with the MS animal data having been published in a peer reviewed scientific journal. ATL1102 was previously shown by Antisense Therapeutics to be highly effective in reducing MS lesions in a Phase II clinical trial in MS patients. The company has also lodged a patent on ATL1102 supporting its’ potential application as a stem cell mobilization agent.
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