Prana Biotechnology Limited, a development stage company, develops therapeutic drugs designed to treat the underlying causes of degeneration of the brain as the aging process progresses, focusing on Alzheimer’s disease, Huntington’s disease and Parkinson’s disease and other movement disorders. Other potential applications for the company’s therapies include neurodegenerative disorders, certain cancers, age-related macular degeneration, Motor Neuron disease, Creutzfeldt-Jakob disease (the human variant of Mad Cow disease) and various orphan neurodegenerative disorders. The company’s platform technology addresses the causes of a spectrum of neurodegenerative and age-related diseases based on the interrelationship of metals and proteins. During the financial year 2014, the company’s research strategy has evolved to a two tier program. The first tier encompasses core new chemical entity design, synthesis and characterization, the ‘discovery phase’ of the new entities as potential novel metal protein attenuating compounds (MPACs’) of interest. Its discovery research has established structure function relationships within chemical moieties that guide its chemists towards therapeutic MPAC based treatments for neurodegenerative disorders. The discovery phase also includes preliminary bioavailability and pharmacokinetic characterization of its MPCS. The second tier comprises a set of dedicated proof of concept animal modelling to establish dose relationships relative to tolerability and efficacy, its ‘Translational Research’ program. The company has initiated a program of research into the potential use of selected MPACs from its library for use in the treatment of brain cancer, in particular the most prevalent and deadly form of the disease, Glioblastoma Multiforme (GBM). The most commonly prescribed treatments are chemotoxic agents together with radiation therapy, which confer a median survival increase of several months. Several of the company’s MPACs that demonstrate potent toxicity against human gliomablastoma cell lines and yet remain untoxic to normal brain cells are being tested in mouse models of GBM. Regulatory Considerations The company’s ongoing research and development activities are subject to regulation by human research ethics committees and institutional research boards, as well as various governmental authorities in Australia, principally the Therapeutics Goods Administration, the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency. Manufacturing The company’s primary compound, PBT2, is manufactured by Dr. Reddy’s Laboratories Limited. History Prana Biotechnology Limited was founded in 1997. The company was incorporated under the laws of the Commonwealth of Australia in 1997.
prana biotechnology ltd (PRNAF:OTC US)
369 Royal Parade
Parkville, VIC 3052
Phone: 61 3 9349 4906
Fax: 61 3 9348 0377www.pranabio.com
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