Investigational VOLT01 Demonstrates ‘Superior Efficacy and Safety’ in Exploratory Research
BETHLEHEM, Pa. (November 18, 2014) – Levolta Pharmaceuticals, Inc. today presented the results of an exploratory Phase II study for a potential disease modifying drug for patients with knee osteoarthritis (OA) at the 2014 American College of Rheumatology (ACR) Annual Meeting in Boston, demonstrating that its investigational VOLT01 had “superior efficacy and safety” when compared to zoledronic acid (ZA), which was used as a positive control.
In a single blind, single center study, 32 subjects with knee osteoarthritis were randomized to receive either intravenous VOLT01 or ZA in a 1:1 ratio. At 48 hours post treatment, patients were assessed for common ZA side effects, including fatigue, body aches, joint pains, fever and myalgia, symptoms. Follow-up evaluations at six months examined knee pain by visual analogue scale and bone marrow density. The clinical trial results showed that VOLT01 significantly reduced pain (35mm vs. 10mm) as compared to ZA when measured by the change in mean Visual Analogue Scale (VAS) and significantly decreased the incidence of Post-Dose Syndrome (PDS) (12.5% vs. 56.3%) as compared to ZA. The efficacy data was deemed statistically significantly superior with a p<0.05.
“VOLT01 clearly demonstrated superior efficacy in controlling knee OA pain when compared to ZA alone,” said Levolta Chief Medical Officer Ketan Desai, M.D., Ph.D. “In addition, the post dose syndrome normally associated with ZA administration was greatly reduced in VOLT01. It is important to note the sustained effect of VOLT01 treatment, with a significant reduction in pain still being reported at six months after a single infusion. We are hopeful that VOLT01 will be the first disease modifying osteoarthritis drug, with the potential to become a first line treatment for OA.”
The United States Patent and Trademark Office (USPTO) recently awarded Levolta a patent for VOLT01, a derivative of ZA.
OA is a major, but poorly understood, public health problem. It is anticipated that OA will become the fourth leading cause of disability by the year 2020, according to the World Health Organization.
“There is currently no treatment that stops or delays OA progression,” said Levolta Chief Executive Officer Richard P. Becker, Jr. “OA is a major burden on individuals, health care systems, and social service systems, which is expected to increase dramatically as our population ages. Successful VOLT01 Phase III trials will make it a first line defense against OA, providing payers with a pharmacoeconomic benefit through reduced joint replacement surgeries and significantly enhanced quality of life for patients.”
A current Phase III multi-center clinical trial with Menzies Research Institute in Australia will assess VOLT01 for controlling knee osteoarthritis with results expected in 2015.
Levolta Pharmaceuticals, Inc.
Based in Bethlehem, Pa., Levolta Pharmaceuticals, Inc., 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. Levolta is a member of BioNJ and Pennsylvania Bio. For more information, please call (848) 702-0682 or visit www.levoltapharma.com.
Yankee Public Relations
Levolta Pharmaceuticals, Inc.
116 Research Dr.
Bethlehem, PA 18015