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Elastagen Expands Clinical Program for Elastin Products.
20 / 09 / 2011
· Phase 1A clinical study demonstrates excellent biocompatibility
· Elastatherapy® products to be pursued in two further clinical trials
· European launch of products planned for early 2013
September 2011, Sydney: Following the successful conclusion of its first-in-man study conducted earlier this year, Elastagen has expanded its clinical program to assess the safety and efficacy of its Elastin products in the augmentation and repair of aged and damaged skin. The first–in-man clinical study was designed to evaluate the safety of the synthetic human Elastin products after implantation in the upper arms of 14 healthy volunteer subjects. It was conducted in Australia and concluded in May 2011.On the back of positive outcomes from this trial, Elastagen now plans two further clinical studies to evaluate the potential of Elastatherapy™ for the treatment of aged and damaged skin. The additional studies will initiate in Q4 2011 and run through to the second half of 2012. If positive, the clinical data will be sufficient to support CE Mark approval of the products.Commenting on the successful first-in-man study, Robert Daniels, CEO of Elastagen noted “Our first clinical study has clearly demonstrated our synthetic human elastin products have a great safety profile and we remain confident that they offer significant potential for the treatment of aged and damaged skin. Our whole approach has been to specifically design a product for human skin and it is encouraging to see positive progress.”Elastagen is pioneering Elastatherapy™ technology using a synthetic version of the human protein Elastin to naturally repair and augment the skin. The Elastatherapy™ treatments offer the chance to restore the levels of Elastin in human skin, with benefits anticipated in both cosmetic and medical dermatology applications.Commenting on progress during 2011, Chairman of Elastagen, Andrew Sneddon added “These encouraging clinical results for the Elastin products take us a significant step closer to having a truly innovative and exciting new treatment for this growing market sector. Elastagen will now begin to put in place its plans for entry into Europe in addition to continuing discussions with potential commercial partners.” For further information please contact:
Robert Daniels, CEO
+61 9209 4054
r.daniels@elastagen.com
About Elastagen Pty Ltd.
Elastagen is a clinical stage medical device company that is pioneering Elastatherapy™ using the human protein Elastin to naturally repair and augment the skin. Skin elasticity deteriorates with age due to the progressive loss of the Elastin protein, one of the three key molecules associated with youthful skin. Two of these molecules, Hyaluronic Acid (HA) and Collagen, are already used in aesthetic dermatology, but the potential for Elastin has remained untapped and offers a novel direction in anti-ageing therapy. Elastagen has pioneered the scientific understanding of Elastin and the “elastagenesis” process. Elastagen is also the first company to have succeeded in the scaleable commercial GMP compliant manufacture of full length recombinant human Elastin for use in dermatology applications. The Company is currently conducting multiple clinical studies to evaluate the potential of its Elastin formulations to augment the skin and restore elasticity in both cosmetic and medical dermatology applications. Elastagen is located in Sydney, Australia, and is a venture backed private company. Investors include ATP Innovations, Brandon Capital and GBS Ventures. Further information on Elastagen can be found at www.elastagen.com