, May 15, 2014
/PRNewswire-USNewswire/ -- NovelMed Therapeutics announced today positive data using its novel, humanized monoclonal antibody in two well-established models of osteoarthritis (OA), characterized by osteophyte formation and cartilage loss. Approximately one in ten people worldwide are affected by OA, with the total number of afflicted patients expected to increase from 75 million in 2009 to 82 million in 2016, largely due to the aging population in conjunction with a rise in obesity rates.
The studies were evaluated in a blinded fashion by Dr. Alison Bendele of Bolder BioPATH, Inc. (Boulder, Colorado). In the animal models, the humanized antibody demonstrated dramatic effects in reducing cartilage degeneration and osteophyte formation by greater than 90% compared to controls in two models of osteoarthritis. No therapy currently exists that is able to modify disease by altering the structural deterioration of the affected joint. Virtually all of the approved agents for OA only control symptoms of the disease such as pain and mobility.
Recent toxicology studies in primates with this antibody demonstrated no adverse effects including complete lack of microscopic histologic findings. Phase I human studies are planned by the end of 2014 which would then lead to the ability to pursue Phase II clinical trials in OA shortly thereafter.
"In the biologic arena, every drug target is unique and every antibody targeting the same protein has different and highly specific characteristics. Millions of antibodies can be generated against a single protein target it is the selection and orchestrated testing of the selected product that is the critically important factor. As a result, we have differentiated products in our portfolio of antibodies suited for inflammatory and non-inflammatory arthritis. We are thrilled with the recent results of OA as this disease represents a major and growing unmet need in the elderly population worldwide. We believe that our technology is novel and could revolutionize the treatment options for OA indications," stated Dr. Rekha Bansal, Founder & Chief Executive Officer of NovelMed Therapeutics, Inc.
About OA Disorders
Osteoarthritis is the most common form of arthritis, affecting over 75 million people worldwide. Often called a "wear-and-tear disease", osteoarthritis occurs when the protective cartilage on bone terminals wear down over time. While osteoarthritis can damage any joint, the disorder most commonly affects joints in the knees, hips, hands, and neck. Osteoarthritis gradually worsens with time, and no cure exists. The etiology of OA is poorly understood. Globally, OA is expected to represent over a $5 billion dollar market looking ahead with a compound annual growth rate of 1.5%.
NovelMed Therapeutics, Inc. is a privately-held biotechnology company located in Cleveland, Ohio, that is developing transformative treatments for orphan and non-orphan disease conditions. The Company's focus is on designing and developing superior treatments for non-complement and complement-mediated inflammatory and hemolytic disorders including Osteoarthritis (OA), Rheumatoid Arthritis (RA), Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), ocular inflammation and vision loss (Dry & Wet AMD), and cardiovascular diseases. NovelMed's drug candidates, differentiated by their unique mechanism(s) of action, are expected to deliver therapies with superior efficacy and enhanced safety and dosage profiles. NovelMed has developed a portfolio of antibody therapies that are suited for various clinical indications with a focus on unmet-needs.
NovelMed's proprietary technology for OA is supported by multiple meritorious SBIR awards from the National Institute of Health (NIH). NovelMed's intellectual property includes patents and patent applications that cover a diverse discovery landscape.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Research reported in this press release was supported by the National Institute of Aging of the National Institutes of Health.
Press Release Contact for NovelMed:
Jeffrey A. Green, Pharm.D.
Vice President, Clinical Affairs and Business Development
Tel: (216) 712 5531
Logo - http://photos.prnewswire.com/prnh/20130909/DC73243LOGO