Dosing Completed in ATL1103 Clinical Trial
- Category: DNA RNA and Cells
- Published on Tuesday, 11 October 2011 03:00
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Trial Results on track to be reported by end of this year
Victoria, Australia | October 11, 2011 | Antisense Therapeutics Limited (ASX:ANP) is pleased to advise that the dosing of subjects has now
been completed in the Phase I trial of the Company’s growth hormone receptor (GHr) targeting drug ATL1103.
The ATL1103 Phase I trial is a randomized, placebo controlled, double blind study of single ascending doses and multiple doses of ATL1103 in healthy adult male subjects.
The multiple dosing phase of the trial has now concluded with no serious adverse events reported over the 21 day dosing period. Subjects have now entered the monitoring phase of the study where they will continue to be assessed for potential residual effects of the dosing phase. The ATL1103 Phase I trial remains blinded and as such the outcomes of the trial will not be known until the monitoring phase and all laboratory testing is completed. The study is un-blinded after all the clinical trial data is entered into the trial database and the database locked for analysis. This process remains on track to be completed in time for the trial results to be reported by the end of this year (2011).
ATL1103 is designed to block the expression of GHr and thereby reduce levels of the hormone insulin-like growth factor-I (IGF-I) in the blood (serum). Reducing elevated levels of serum IGF-I to normal is the therapeutic endpoint in the treatment of the growth disorder acromegaly, and reducing the effects of IGF-I also has a potential role in the treatment of diabetic retinopathy, diabetic nephropathy and certain forms of cancer.
ATL1103 is a second generation antisense drug designed to block growth hormone receptor (GHr) expression thereby reducing levels of the hormone insulin-like growth factor-I (IGF-I) in the blood and is a potential treatment for diseases associated with excessive growth hormone and IGF-I action. These diseases include acromegaly, an abnormal growth disorder of organs, face, hands and feet, diabetic retinopathy, a common disease of the eye and a major cause of blindness, diabetic nephropathy and some forms of cancer. Acromegalic patients are known to have significantly higher blood IGF-I levels than healthy individuals. Reduction of these levels to normal is accepted by clinical authorities as the
primary marker of an effective drug treatment for the disease. GHr is a clinically validated target in the treatment of acromegaly. In the case of diabetic retinopathy, published clinical studies have shown that treatments producing a reduction in IGF-I levels retarded the progression of the disease and improve vision in patients. Scientific papers have been published on the suppression of blood IGF-I levels in mice (Tachas et al., 2006, J Endocrinol 189, 147-54) and inhibition of retinopathy in a mouse retinopathy model (Wilkinson-Berka et al., 2007, Molecular Vision 13, 1529- 38;) using an antisense drug to the GHr. ANP have also previously reported that ATL1103 suppressed circulating levels of IGF-I in primates and that toxicology studies had been completed supporting the Company’s plans to move ATL1103 into clinical development. ATL1103 commercialisation is covered by patents to at least 2024, with the potential for extensions up to 2029 in some countries and 2030 in the US.
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. ATL1102 (injection) has successfully completed a Phase II efficacy and safety trial, significantly reducing the number of brain lesions in patients with multiple sclerosis.
ATL1103 is 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 vision disorders. ATL1102 (inhaled) is at the pre-clinical research stage as a potential treatment for asthma. ATL1101 is a second-generation antisense drug at the pre-clinical stage being investigated as a potential treatment for prostate cancer.
SOURCE: Antisense Therapeutics Limited