|By PR Newswire||
|January 7, 2014 05:50 PM EST||
SAN FRANCISCO, Jan. 7, 2014 /PRNewswire/ -- Antisense Therapeutics Limited ("ANP" or "the Company") is pleased to advise that it has been selected to present at the Biotech Showcase 2014 conference to be held January 13-15, 2014, at The Parc 55 Wyndham Hotel in San Francisco, CA. This is a significant opportunity for ANP to present to and engage with distinguished US-based investors, prospective partners, and key industry leaders, and in particular discuss the successful progress of the company's Phase II acromegaly trial for ATL1103.
Biotech Showcase 2014
Tuesday, January 14, 2014
2:30 pm (Pacific Time)
Parc 55 Wyndham San Francisco Union Square Hotel
The presentation will be webcast live. To access the webcast, please visit the home page of the Antisense website at http://www.antisense.com.au. The webcast will be archived and available for 90 days.
Mark Diamond, Managing Director and CEO of Antisense Therapeutics, will provide an overview of the Company's business and discuss the recently announced positive data from the interim analysis of their ATL1103 Phase II acromegaly trial. He will also be available to participate in one-on-one meetings with investors and prospective partners who are registered to attend the conference.
Biotech Showcase is an investor and partnering conference devoted to providing biotechnology and life sciences companies an opportunity to present to and meet with investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
ATL1103 Phase II trial is a randomised, open-label, parallel group study of the safety, tolerability, pharmacokinetics and efficacy of two subcutaneous dosing regimens of ATL1103 in 24 adult patients with acromegaly dosed with ATL1103 for 13 weeks (3 months) with two months of follow up. Two ATL1103 dosing regimens are being tested (a) 200 mg 3 times in the first week then once weekly thereafter (200 mg/week) or (b) 200 mg 3 times in the first week then twice weekly thereafter (400 mg/week). The primary endpoints or main purposes of the trial as listed on the trial protocol are (i) to evaluate the safety and tolerability of ATL1103 in patients with acromegaly, and (ii) to evaluate the single dose and multiple dose pharmacokinetic profiles of ATL1103 via the subcutaneous route in patients with acromegaly. A secondary, but important endpoint that is also on the trial protocol is the evaluation of ATL1103's effect on serum insulin like growth factor I (IGF-I) levels in patients. The secondary endpoint is the average percentage reduction in serum IGF-I levels at the end of treatment compared to baseline levels for each of the two dosing regimens used in the Phase II study.
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, a common disease of the kidney and major cause of kidney failure, 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 reported that ATL1103 suppressed circulating levels of IGF-I in primates. In a Phase I study in normal volunteers, ATL1103 was assessed as being safe and well tolerated, while also demonstrating a preliminary indication of drug activity including suppression of IGF-I and the target GHR (growth hormone binding protein) levels. 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.
Acromegaly is a serious chronic life threatening 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 (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 and Europe there are approximately 85,000 acromegaly patients with about half requiring drug therapy. Cost of drug therapy ranges from approximatelyA$30,000/annum to over A$60,000/annum depending on the treatment.
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, 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.
Managing Director: Mark Diamond +61 (3) 9827 8999
USA Investor/Media: Joshua Drumm +(1) 212 375 2664; [email protected]
Australia Investor/Media: Simon Watkin +61 (0)413 153 272; [email protected]
SOURCE Antisense Therapeutics Limited
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