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news.Levolta Pharmaceuticals an emerging leader in developmental osteoarthritis (OA) therapy, has announced that the US Patent and Trademark Office has awarded the company a patent for its novel VOLT01, a derivative of zoledronic acid (ZA), a proposed commercial product that has shown promise as a disease-modifying drug in clinical trials.
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US Patent 8,859,530 covers co-administration of steroids and zoledronic acid to prevent and treat osteoarthritis.
Formerly known as Voltarra Pharmaceuticals, Levolta’s patent claims methods for treating osteoarthritis by intravenously administering a combination of prednisolone, or a pharmaceutically acceptable salt thereof, and ZA, or a pharmaceutically acceptable salt thereof, in a single infusion. The patent claim does not limit the dosage of the prednisolone or the ZA. A dependent claim specifies a dosage range of between 5 mg and 50 mg of prednisolone, which encompasses all considered dosages.
"The patent is great news for Levolta and, more importantly, covers a method for providing long-term relief to osteoarthritis patients, which is desperately needed due to the ever rising number of people dealing with this illness," said Levolta CEO Richard P. Becker, Jr. "In clinical trials, not only does prednisolone minimize the incidence of side effects associated with ZA administration, it also provides long-term relief from the OA symptoms. Patients are in strong need of a disease-modifying drug for OA so this is exciting news for the healthcare community."
The World Health Organization estimates that osteoarthritis will be the leading cause of disability globally by 2020. The Centers for Disease Control and Prevention reports that osteoarthritis affects 26.9 million U.S. adults with total healthcare system costs of $21.1 billion.
"In an earlier randomized clinical trial, VOLT01 demonstrated significantly better safety and efficacy in controlling knee osteoarthritis compared to ZA alone, with the added benefit of no post dosing symptoms," said Levolta Chief Medical Officer Ketan Desai, M.D., Ph.D.
"We have initiated a Phase III multi-center clinical trial with Menzies Research Institute to assess VOLT01 for controlling knee osteoarthritis and expect to announce results in early 2015. Creating a disease-modifying drug for osteoarthritis patients would bring vast patient quality of life and societal benefits and we are very encouraged by progress to date."
ZA is effective in treating OA symptoms, but produces post-dose syndrome side effects, notably flushing, fever, joint pains and muscle aches. Originally marketed by Novartis as Reclast and ZOMETA, ZA is used to treat osteoporosis, Paget’s disease and bone cancers, a market that Levolta estimates was $6.2 billion in 2011. ZA had sales in excess of $1.6 billion in 2012.