Antisense Therapeutics Limited (“ANP” or the “Company”) is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose). The Company believes that the preclinical and clinical experience to date with ATL1102 should allow dosing in future trials at or above the 1.5 mg/kg/dose level.
Based on histologic findings in common with a previous monkey study at doses exceeding 1.5mg/kg/dose, the Company continues to evaluate the chronic monkey data with regard to potential human relevance, and safety biomarkers that may be useful in future clinical studies. Exposures achieved in this study are regarded as potentially clinically relevant based on the efficacy outcomes from the previously conducted Phase IIa trial of ATL1102 in MS patients.
Pending receipt and final data evaluation from the current study, as well as review of all the preclinical and clinical data obtained, ANP is planning future regulatory agency discussions regarding further development of ATL1102 and the dosing regimen for a future Phase IIb trial in MS patients. The Company anticipates final review of the data by June this-year and follow-up discussions with the US Food and Drug Administration (FDA) at a pre-IND meeting during the 3rd quarter 2014.
Antisense Therapeutics CEO and Managing Director Mark Diamond said “The results of this most recent toxicology study and the human data to date are encouraging and re-ignite our hopes for this project. We are continuing to generate new data on ATL1102 which we believe will support positive interactions with the FDA in relation to our plans for a future Phase IIb trial in MS patients. We look forward to confirming our plans for the further clinical development of ATL1102 with the FDA in the coming months.”
Source: www.news-medical.net/ (02/04/14)
Antisense Therapeutics (ASX: ANP) has significantly lowered the costs associated with its planned chronic toxicology study of the drug ATL1102.
The company now expects the study, which will support a potential future phase IIb study of ATL1102 in multiple sclerosis patients, to cost less than A300,000 to complete.
Importantly, Antisense is able to fund the study without it having a material effect on cash flow forecasts which cover planned activities well into 2014.
This is largely due to Antisense's choice of China's Pharmaron as the contract research organisation and agreement of the study design, as well as not having to manufacture new ATL1102 drug product for the study by qualifying existing clinical supplies.
The multiple sclerosis therapeutics market has grown significantly and is now valued at US12 billion.
Antisense has finalised preparations for the chronic toxicology study and expects to complete it by the end of the year.
ATL1102, with the recent granting of a U.S. patent significantly extending its patent life, has high commercial potential, particularly if the toxicology study clears the way for the conduct of phase IIb studies.
Meanwhile, in parallel with the toxicology study, partner Tianjin International Joint Academy of Biotechnology and Medicine will undertake a stem cell mobilisation study at its own cost at the company's Tianjin, China facility.
This study will investigate the potential of ATL1102 to release stem cells into the blood when dosed over a short one week period.
This will be beneficial for the planning of future human studies in which the drug will also be dosed acutely.
While this study is underway, Tianjin and Antisense will prepare and submit a clinical trial application for a follow on human stem cell mobilisation study based on data previously generated.
This study will use ATL1102 to optimise the release of stem cells for their collection from the blood to characterise their potential use in cancer patients to restore immune cells depleted by chemotherapy.
Tianjin and Antisense have agreed on an extension to the establishment of the joint venture proposed under the Strategic Alliance and Licence Agreement to allow the two studies to go ahead without delay.
Tianjin was established as part of an initiative of the Chinese Government and State Food and Drug Administration to accelerate economic growth and develop the country's biotech industry.
At the end of December 2012, Antisense had cash reserves of 5.1 million.
Menafm.com © 2013 menafn.com (19/03/13)
Antisense Therapeutics has been granted a U.S. patent covering its ATL1102 drug in the treatment of multiple sclerosis.
The patent extends coverage of the ATL1102 compound for the treatment of relapsing-remitting multiple sclerosis patients until 2029 with the potential for up to a five year extension to 2034.
Antisense also has patent applications under examination in Europe, Japan, Canada, and Australia.
Additional patent protection in relation to the antisense technology and manufacturing is also provided internationally for ATL1102 by Antisense's technology partner Isis Pharmaceuticals.
A previous phase two study has confirmed the drug's activity in potently suppressing brain lesions in relapsing-remitting multiple sclerosis patients.
There are significant commercial deals taking place in the multiple sclerosis space including Biogen Idec's purchase of Elan's stake in Tysabri, and Merck Serono's option over Opexa's Tcelna therapy, a multiple sclerosis treatment entering phase IIb trials.
Move towards phase IIb study
Testing of the ATL1102 formulated material for suitability for use in a chronic toxicology study has now confirmed the material's suitability for its intended application.
The material will be shipped to China for use in the toxicology study that is designed to support a potential future phase IIb study of ATL1102 in multiple sclerosis patients.
Antisense and Chinese partner Tianjin International Joint Academy of Biotechnology and Medicine (TJAB) are in discussions regarding the commencement of the toxicology study ahead of establishing the joint venture.
TJAB was established as part of an initiative of the Chinese Government and State Food and Drug Administration to accelerate economic growth and develop the country's biotech industry.
Potential applications for ATL1102 include the areas of multiple sclerosis, stem cell mobilisation and asthma.
Source: MENAFN.com © 2000 menafn.com (14/02/13)