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Voltarra Pharmaceuticals And Menzies Research Institute Phase 3 Clinical Trial For Controlling Knee Osteoarthritis


5/20/2014 10:39:00 AM

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BETHLEHEM, Pa. (May 20, 2014) – Voltarra Pharmaceuticals, Inc. and Menzies Research Institute at the University of Tasmania in Hobart, Australia have initiated a Phase III multi-center clinical trial to assess the efficacy and safety of VOLT01 for controlling knee osteoarthritis (OA).

The World Health Organization estimates that osteoarthritis will be the leading cause of disability globally by 2020. In the U.S., the Centers for Disease Control and Prevention reports that osteoarthritis affects 26.9 million adults with total costs of $21.1 billion. In Australia, OA was estimated to affect over 1.6 million people with total costs of $1.4 billon.

“Knee osteoarthritis is the most common form of osteoarthritis and is increasing markedly due to an ageing population,” said Voltarra Chief Executive Officer Richard P. Becker, Jr. “There are no disease-modifying drugs available that can slow the progression of the disease. OA costs the public billions of dollars annually in medical expenses, hospital stays and missed time from work. We are hopeful that VOLT01 will change the way the world deals with this disease.”

VOLT01 is a derivative of zoledronic acid (ZA), a drug that slows the loss of bone mass. Originally marketed by Novartis as Reclast®, ZA is used to treat osteoporosis, Paget’s disease and bone cancers, a market that Voltarra estimates was $6.2 billion in 2011. ZA, administered intravenously, had sales in excess of $1.6 billion in 2012.

“We are optimistic that VOLT01 will demonstrate greater effectiveness as a disease modifying drug than ZA alone,” said Voltarra Chief Medical Officer Ketan Desai, M.D., Ph.D. “ZA has been shown to be effective in treating the symptoms of OA, but produces post-dose syndrome side effects, notably flushing, fever, joint pains and muscle aches. There is an urgent need for research that investigates innovative and cost-effective approaches to slow the progression of osteoarthritis.”

Study Director Graeme Jones invited Voltarra to join the clinical trial upon learning of VOLT01’s superior efficacy and safety results versus Novartis’ Reclast® in a head-to-head randomized phase II trial. Jones is Professor of Rheumatology and Epidemiology and Head of the Musculoskeletal Unit at the Menzies Research Institute as well as Head of the Department of Rheumatology at Royal Hobart Hospital. The VOLT01 research is one arm of the study entitled, “A randomized trial of zoledronic acid and VOLT01 for osteoarthritis of the knee,” a multi-center randomized, placebo-controlled, double-blind clinical trial under the auspices of Medicines Australia.

“Osteoarthritis is a major, but poorly understood health problem,” Jones said. “OA is characterized by a gradual loss of articular cartilage and changes to other joint structures, eventually leading to total joint replacement. Osteoarthritis is a major burden on people, health systems and social care systems globally and will only become more so until disease-modifying drugs are made available.”

“The importance of developing a disease-modifying drug for osteoarthritis patients cannot be underscored enough,” Dr. Desai added. “Obviously, there are major quality of life issues to consider for individuals, but there are also potentially vast societal benefits by decreasing the number of related surgeries, drug purchases, healthcare expenses and time lost from work.

The study is open to men and women who are age 50 and above; have significant knee pain on most days; show an abnormality present on an MRI scan; and are diagnosed with clinical knee osteoarthritis.

The study is being conducted at four research sites. For study information please contact the following:

- The Menzies Research Institute, Hobart: Kathy Buttigieg, (03) 6226 6909 or Kathy.Buttigieg@utas.edu.au;
- Institute of Bone and Joint Research, The University of Sydney: Emma Smith, (02) 9463 1888 or emma.smith@sydney.edu.au;
- Monash University, Alfred Centre, Melbourne: Judy Hankin or Alice Noone, (03) 9903 0553 or jointstudy@monash.edu; and
- The Queen Elizabeth Hospital, Adelaide: Peter Rogers, (08) 8222 7369.

“Entering a Phase III registration trial is an important milestone for Voltarra,” Becker said. “We expect that interim study data will be available in approximately the first quarter of 2015 and hope that data analysis at that point will support expansion of the clinical trial in the U.S. and globally. We also anticipate applying for a New Drug Application with the Therapeutic Goods Administration in 2017.”

Voltarra Pharmaceuticals, Inc.
Based in Bethlehem, Pa., Voltarra Pharmaceuticals features a portfolio of early-stage small molecules and late-stage novel clinical compounds for rheumatology, the central nervous system, oncology and immunology, which the company obtained through the acquisitions of IMC Biotechnology and Renascense Pharmaceuticals. Voltarra is a member of BioNJ and Pennsylvania Bio. For more information, please call (848) 702-0682 or visit www.voltarrapharma.com.

Menzies Research Institute, University of Tasmania
The Menzies Research Institute aspires to contribute significantly to human health and wellbeing, with particular emphasis upon research that takes advantage of Tasmania's unique population resource and other competitive advantages. Its research efforts focus on preventing a range of diseases including cancer, multiple sclerosis, cardiovascular disease, diabetes, chronic lung disease, osteoporosis, epilepsy and dementia. For more information, please visit www.menzies.utas.edu.au.

MEDIA CONTACT:
Fred Feiner
Yankee Public Relations
(908) 425-4878
fred@yankeepr.com

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