MiReven Announces Positive Preclinical Results for miR-7 in Head and Neck Cancer

Perth, Western Australia, October 25, 2012 – MiReven, an Australian microRNA company commercialising discoveries from the Western Australian Institute for Medical Research (WAIMR) on the anti-cancer potential of miR-7, today announced the publication in the journal PLOS One of a study in which miR-7 was examined in combination with the head and neck cancer (HNC) treatment erlotinib hydrochloride (Tarceva, Genentech/OSIP).

Epidermal growth factor (EGFR) inhibitors are effective in only 20-30% of patients with head & neck cancer. The present study, which was conducted at the WAIMR, examined the capacity of miR-7 to regulate head and neck cancer growth in vivo and the combination of miR-7 with erlotinib in vitro, where it sensitised resistant cells to the tumour suppressive effects of erlotinib. Further, a microarray study found that miR-7 downregulated multiple mRNAs associated with the epidermal growth factor receptor (EGFR)/protein kinase B (Akt) signaling pathway, which is strongly associated with the development, progression and treatment resistance of HNC.

Professor Peter Leedman from the WAIMR, who led the study, explained:

“Although EGFR inhibitors like erlotinib have been developed for the treatment of many cancers, they are often not very effective, with responses typically short and tumours building up resistance quite quickly. However, when we combined erlotinib with the anti-cancer microRNA, miR-7, its effectiveness increased. “

Dr Keith Giles, a member of the WAIMR team, added:

“The experiments in the PLOS One publication reinforce miR-7’s promise as an anti-cancer therapeutic, and provide additional insight into its mechanism of action.”

Dr Stephen Thompson, Chairman of MiReven Pty Ltd, said:

“microRNA drugs like miR-7 are offering a new direction for cancer therapeutic interventions in addition to monoclonal antibodies and small molecule inhibitors. These results demonstrate the potential for miR-7 to be a useful adjunctive therapy in the treatment of head and neck cancer. We have a number of other studies underway and are hopeful that once complete, we will be able to identify a partner to advance miR-7 into clinical development.”

The study is published today in the peer reviewed online journal PLOS ONE and is entitled “Regulation of epidermal growth factor receptor signaling and erlotinib sensitivity in head and neck cancer cells by miR-7” by Felicity C. Kalinowski, Keith M. Giles, Patrick A. Candy, Alishum Ali, Clarissa Ganda, Michael R. Epis, Rebecca J. Webster and Peter J. Leedman

http://dx.plos.org/10.1371/journal.pone.0047067

Further Information:

Stephen Thompson

Chairman

MiReven Pty Limited

t: +61 (03) 9657 0700

e: sthompson[at]brandoncapital.com.au

Douglas Pretsell

Senior Consultant

College Hill Life Sciences

t : +61 (0)466 925 966

e: douglas.pretsell[at]collegehill.com

About MiReven

MiReven Pty Ltd was formed in 2010 through an investment from the Medical Research Commercialisation Fund (MCRF). The company is commercialising the pioneering work of Prof Peter Leedman and Dr Keith Giles at the Western Australian Institute for Medical Research (WAIMR) on the anti-cancer potential of miR-7. WAIMR’s published research shows that miR-7 can knock-out an essential growth receptor for cancer, known as the epidermal growth factor receptor (EGFR), as well as its associated signaling pathways that promote cancer development. EGFR is a major target for cancer therapy because it is often associated with disease progression, resistance to chemotherapy and radiation therapy. WAIMR is assisted in the commercialisation of its intellectual property by the University of Western Australia, through its Office of Industry and Innovation.

About MicroRNAs and miR-7

MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act as master regulators to control the expression of sets of genes and entire cellular pathways. Recent studies have demonstrated that microRNAs are associated with many disease processes, including cancer. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.

miR-7 is a microRNA that was found by Professor Leedman and his team at WAIMR to act as a tumour suppressor through inhibition of the epidermal growth factor receptor (EGFR) and its downstream signaling pathways that promote cancer development. EGFR is a major target for cancer therapy because it is often associated with disease progression, resistance to chemotherapy/radiation therapy, and poor prognosis.

About WAIMR

WAIMR is Western Australia’s premier adult medical research institute, investigating the genetic and environmental causes of a range of diseases. Formed in 1998 with a vision of fostering a high-level of collaboration between the State’s medical researchers, our team has made, and continues to make, a number of internationally-important discoveries with the potential to deliver better health to the global community. Currently, WAIMR is situated at two locations - the Perth Campus is located at the Medical Research Foundation building of Royal Perth Hospital, while the Nedlands Campus is at B Block, Queen Elizabeth II Medical Centre.

www.waimr.uwa.edu.au

About The University of Western Australia (UWA)

Established in 1911, UWA is a research-intensive university ranked 96 in the world, 26 for Life & Agricultural Sciences and 51 to 75 for Clinical Medicine & Pharmacy, in the highly respected Shanghai-Jiao Tong University’s Academic Ranking of World Universities in 2012. As Western Australia’s premier university, UWA is a member of the prestigious ‘Group of Eight’-a coalition of the top research universities in Australia- and one of only two Australian universities to belong to the Worldwide Universities Network, a partnership of 18 research-led universities from Europe, North America, North Asia, Australia and Africa. The commercialisation of WAIMR intellectual property is facilitated through UWA’s Office of Industry & Innovation.

www.uwa.edu.au

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