7 May 2015 - Circadian Technologies Limited (ASX:CIR, OTCQX:CKDXY) reports that Dr Kameran Lashkari of Schepens Eye Research Institute/Massachusetts Eye & Ear at Harvard Medical School presented preclinical data overnight at the annual ARVO conference in Denver demonstrating efficacy with Circadian’s targeted therapy OPT-302 (VGX-300). The data demonstrates OPT-302 reduced blood vessel growth and vessel leakage in a mouse model of wet age-related macular degeneration (AMD), either as monotherapy or in combination with the VEGF-A inhibitor aflibercept (Eylea®).
The podium presentation entitled “VGX-300, a ‘Trap’ for VEGF-C and VEGF-D, inhibits choroidal neovascularization and vascular leakage in a mouse model of Wet AMD” was part of the AMD Novel Therapies session. The presentation focussed on preclinical data that underpinned the Company’s decision to progress its lead molecule OPT-302 into the clinic for the treatment of wet AMD.
The Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries.
Wet AMD is the leading cause of blindness in developed countries in individuals over the age of 50. Circadian is developing its lead clinical product candidate OPT-302 and remains on-track to initiate a Phase 1 clinical study under an IND at US clinical sites in the first half of 2015.
A copy of the presentation is available at www.circadian.com.au and www.opthea.com Dr Lashkari will also present preclinical data describing the activity of OPT-302 in a poster presentation at the 33rd Annual Meeting of the American Society of Retina Specialists (ASRS) to be held 11-14 July in Vienna.
Company and media enquiries:
Megan Baldwin, PhD
CEO & Managing Director
Circadian Technologies
Tel: +61 (0) 3 9826 0399
megan.baldwin@circadian.com.au
Rudi Michelson
Monsoon Communications
Tel: +61 (0) 3 9620 3333
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Tel: +61 (0) 3 9826 0399
info@circadian.com.au
www.circadian.com.au
About Circadian Technologies Limited
Circadian (ASX:CIR; OTCQX:CKDXY) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF)-C and -D. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are substantial and broad. Circadian’s internal product development programs are primarily focused on developing OPT-302 (formerly VGX-300, soluble VEGFR-3) for ‘back of the eye’ disease such as wet age-related macular degeneration (wet AMD). Circadian has also licensed rights to some parts of its intellectual property portfolio for the development of other products to ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, including the anti-lymphatic antibody-based drug IMC-3C5 targeting VEGFR-3.
About Wet AMD
Wet (neovascular) age-related macular degeneration, or wet AMD, is a disease characterised by the loss of vision in the middle of the visual field caused by degeneration of the central portion of the retina (the macula). Abnormal growth of blood vessels below the retina, and the leakage of fluid and protein from the vessels, causes retinal degeneration and leads to severe and rapid loss of vision.
Wet AMD typically affects individuals aged 50 years or older, and is the leading cause of blindness in the developed world. The prevalence of AMD is increasing annually as the population ages. Sales of the drug Lucentis® (Roche/Novartis), which targets VEGF-A but not VEGF-C, were over $US4BN in 2014. Sales of EYLEA™ (Regeneron/Bayer), which also targets VEGF-A but not VEGF-C first marketed in November 2011 for the treatment of wet AMD, were over $US1.8BN in 2014. Approximately half of the people receiving Lucentis®/Eylea® are classified as non-responders or ‘poor’ responders and experience no significant gain in vision and/or have persistent retinal vascular leakage. There is great opportunity to improve patient responses by targeting more than one factor involved in disease progression. Existing therapies, such as Lucentis®/Eylea®, target VEGF-A that promotes blood vessel growth and leakage through its receptor VEGFR-2. VEGF-C can also induce angiogenesis and vessel leakage through the same receptor. Combined inhibition of VEGF-A and VEGF-C, has the potential to improve patient response by more effective inhibition of the pathways involved in disease progression.
Inherent risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Circadian are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Thus investment in companies specialising in drug development must be regarded as highly speculative. Circadian strongly recommends that professional investment advice be sought prior to such investments.
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