Fibrotech announces positive preclinical proof of concept

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Posted: 2012-03-01 in Press Releases

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Fibrotech announces positive preclinical proof of concept

Melbourne, Australia- 1st March 2012 – Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that it has achieved preclinical proof of concept for FT011 in a series of studies using animal models of diabetic kidney disease.

FT011 is the most advanced antifibrotic agent from a series of around 150 analogues of tranilast (Rizaben®) that Fibrotech has generated in recent years. Tranilast is a known antifibrotic agent which is off patent and is approved for the treatment of asthma, allergic rhinitis and atopic dermatitis in humans in Japan.

FT011 was effective at preventing kidney fibrosis in a series of preclinical studies. FT011 demonstrated no evidence of toxicity even at ten times the therapeutic dose. The product also prevented fibrosis, preserved kidney function and reduced albuminuria in an animal model of diabetic nephropathy, as well as preserving systolic and diastolic function in models of heart failure. In comparison with tranilast (Rizaben®) FT011 has comparable bioavailability but is more effective at attenuating TGF-β induced collagen synthesis in cultured kidney mesangial cells and cardiac fibroblasts and can halt the progression of late stage diabetic nephropathy at lower therapeutic doses than tranilast.

Prof. Darren Kelly, CEO of Fibrotech commented:
“These preclinical results clearly show that FT011 is more efficacious and less toxic than tranilast, and is an effective antifibrotic. We will now begin the process of seeking ethical approval to start a clinical trial.”

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About Fibrotech Therapeutics Pty Ltd
Fibrotech is an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis (tissue scarring). The Company develops novel anti-fibrotic drug candidates for the treatment of the fibrosis prevalent in such chronic conditions as chronic kidney disease, chronic heart failure, pulmonary fibrosis and arthritis. Fibrotech’s lead product FT011 is an antifibrotic to prevent the tissue fibrosis associated with diabetic nephropathy which recently achieved preclinical proof of concept. Diabetic nephropathy is the leading cause of end-stage renal disease, a severe medical condition that can only be managed with dialysis or kidney transplantation. There are several products in preclinical development selected from over 150 analogues, many of which are novel chemical entities and are markedly improved antifibrotic agents. Fibrotech was founded in 2006 and is located in Melbourne Australia. Further information on Fibrotech can be found at www.fibrotech.com.au