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Recce (RCE) Moves Closer To Clinical Study Application With Additional Data On Its Novel Antibiotic



5/19/2017 9:13:53 AM

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SYDNEY Australia 19 May 2017: Recce Limited (ASX: RCE), a preclinical-stage pharmaceutical company engaged in the development of a new class of synthetic antibiotic, today announced new data on its lead compound RECCE® 327, essential for its pending data package for an Investigational New Drug (IND) application to the US Food & Drug Administration (FDA), including successful chemical analysis and structural confirmation of the candidate antibiotic, and its micro-detection in animal blood samples.

Recce Limited executive chairman Dr Graham Melrose said the positive micro-analysis, and verification of the chemical structure and stability of its lead compound gave further support to the company’s clinical strategy and moved it closer to completing the documentation required for its IND.

Dr Melrose confirmed Recce’s current work, compiling the company's IND application to begin a phase I trial as planned and according to its published milestones.

Recce said its US-based Clinical Research Organisation had shown RECCE® 327 could be tracked in the blood of study animals - enabling researchers to trace its path. The tests also confirmed the compound's structure, chemical stability and mode of action as outlined in its patents and manufacturing process.

Dr Melrose said the data re-confirmed earlier tests and added to the growing data package of safety data being compiled as part of its IND application.

He said the next step for the company would be to assess a soon to conclude study of toxicity in rats, utilising the newly developed analytical methods, furthering data for FDA review.

Antibiotic resistant bacterial infections (superbugs) are widely acknowledged as a threat to global human and animal health and several governments together including the United Nations and World Health Organisation have enacted a number of legislative and financial initiatives designed to support the rapid development of new antibiotics. Essential to these initiatives is the development of new antibiotics with novel mechanisms of action, such as RECCE® 327.

About Recce Ltd

Recce Ltd (ASX: RCE) is a world-leader in synthetic-polymer compounds, particularly against all bacteria.  The RECCE® polymers have been synthesized by a very economic method.  RECCE® polymers have shown in laboratory tests that they have continued activity against bacteria, including superbugs, even after repeated use.  Recce is positioned to achieve milestones in both pre-clinical trials for FDA purposes, and the development of the manufacture of RECCE® 327.  Recce has granted patents in Australia, United States, Europe, Japan and China – giving it legal monopolies, and potential financial returns, from manufacture and distribution of its products in about 80% of the world’s pharmaceutical markets for antibiotics.

For further information please visit www.recce.com.au

Issued for and on behalf of Recce by Instinctif Partners.

For more information please contact:
Investor Relations
Peter Williams
CFO & Company Secretary
Recce Ltd

Tel: (08) 9253 9800
Media (Australia)
Andrew Geddes
CityPR
Tel: (02) 9267 4511
Media (International)
Sue Charles/Gemma Harris
Instinctif Partners
Tel: +44 (0)20 7866 7860

Read at BioSpace.com


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