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ATL1103 for Growth & Sight Disorders Project Update

01 Sep 2007

Antisense Therapeutics Ltd. is pleased to report the publication today of positive data from its ATL1103 research program

TOORAK, Australia | August 31, 2007 | Antisense Therapeutics Ltd. (ASX:ANP) is pleased to report the publication

today of positive data from its ATL1103 research program. The peer-reviewed scientific publication describes how administration of an antisense drug targeting the growth hormone receptor (GHr) significantly suppressed blood vessel overgrowth in a mouse model of retinopathy and has been published in the journal “Molecular Vision”. The paper (Wilkinson-Berka et al., “An antisense oligonucleotide targeting the growth hormone receptor inhibits neovascularization in a mouse model of retinopathy”, Molecular Vision 13, 1529-38, 2007) can be viewed at www.molvis.org.

This study, conducted by Associate Professor Jennifer Wilkinson-Berka from Monash University, adds to our previously published mouse data on the suppression of the insulin like growth factor-I (IGF-I) hormone in blood (Tachas et al., J. Endocrinology 189, 147-154, 2006). ANP has previously reported suppression of blood IGF-I levels in monkeys following administration of ATL1103. IGF-I is responsible for the unwanted effects of growth hormone (GH). In diseases of excessive GH action, GH stimulates GHr in the liver, which causes the liver to secrete excess IGF-I.

ATL1103 is a second generation antisense drug designed to block the expression of GHr thereby reducing levels of IGF-I in the blood and is a potential treatment for diseases associated with excessive growth hormone action, including acromegaly (an abnormal growth disorder of organs, face, hands and feet) and diabetic retinopathy. IGF-I suppression is a recognised clinical marker of a drug’s activity in the treatment of these diseases.

Research Director at Antisense Therapeutics Ltd, Dr Christopher Wraight commented that “ATL1103 is underpinned by a solid scientific rationale that is evidenced by our published preclinical pharmacology data. A key feature of our drug development strategy is the ability to measure IGF-I suppression in patients treated with ATL1103 which allows us to confirm the clinical activity of ATL1103 at an earlier stage in clinical studies. ATL1103’s biological target, GHr, is predominantly found in the liver. Recent clinical successes announced by our technology partner Isis Pharmaceuticals Inc. with other liver-targeting antisense drugs give us further confidence in the therapeutic potential of ATL1103.”

Manufacture of ATL1103 for pre-clinical studies and human clinical trials is underway at Isis, with pre-clinical animal toxicology studies anticipated to commence before the end of the year.

Background Information

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 action. These diseases include acromegaly, an abnormal growth disorder of organs, face, hands and feet, and diabetic retinopathy, a common disease of the eye and a major cause of blindness. 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 in patients. ATL1103 is supported by a strong intellectual property position that protects ATL1103 until at least 2023.

Acromegaly is a serious chronic life shortening disease triggered by excess secretion of growth hormone (GH) by benign pituitary tumours. Oversupply of GH over stimulates liver, fat and kidney cells, through their GH receptors, to produce excess levels of Insulin-Like Growth Factor-I (IGF-I) in the blood manifesting in abnormal growth of the face, hands and feet, and enlargement of body organs including liver, kidney and heart. The primary treatments for acromegaly are to surgically remove the pituitary gland and/or drug therapy to normalize GH and serum IGF-I levels. In North America, Europe and Japan there are approximately 40,000 diagnosed acromegaly patients with about half requiring drug therapy. In 2004, the total acromegaly market was valued at US$780M and forecast to grow with the introduction of newer and more effective medications.

Diabetic retinopathy is one of the leading causes of vision loss. Over 5 million Americans aged 18 and older are affected by diabetic retinopathy. Around 12,000-24,000 patients with diabetic retinopathy lose their eyesight each year in the US alone. This condition is caused by new blood vessel formation in the retina or macula (the central part of the retina). In diabetes, high blood glucose can cause oxygen deprivation in certain tissues, which can stimulate factors that induce additional blood vessels in the retina. These new blood vessels may break and bleed into the eye leading to scarring within the eye. Surgical ablative treatments such as photocoagulation (laser therapy) are available but are not completely effective, may cause partial vision loss, and can only be used a limited number of times. There is presently no pharmaceutical therapeutic approved for the treatment of diabetic retinopathy.

About Antisense Therapeutics Limited

Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets.

SOURCE: Antisense Therapeutics Limited

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