Humanized Antibody for Orphan & Non-Orphan Ocular Disorders
CLEVELAND, Sept. 25, 2013 /PRNewswire-USNewswire/ -- Today NovelMed Therapeutics announced preclinical study results for its lead compound in two models of AMD, a major cause of blindness affecting more than 2 million people in the United States.
Two independent preclinical investigations demonstrated that NovelMed's lead compound, an alternative pathway inhibitor, prevents the onset and progression of Wet-AMD. A reduction in neovascularization greater than 65% was noted with a low dose of this lead drug candidate.
Given the antibody's mechanism of action, the drug could control not only Wet-AMD but also Dry-AMD. As a result, vision loss and associated inflammation could be controlled not only in AMD, but also in inflammatory-mediated orphan and non-orphan ocular diseases. Phase I/II safety and efficacy clinical trials are set to begin in late 2014 for the Company's lead humanized monoclonal antibody, a molecule with novel structural elements. Initial clinical trials will focus on an orphan ocular disorder with subsequent trials in non-orphan ocular diseases.
"NovelMed's drug candidates are highly differentiated, and go through our proprietary screening processes to target specific pathways," said Dr. Rekha Bansal, Founder and CEO of NovelMed. "Millions of antibodies can be developed, but the challenge lies in orchestrated testing to distill high potential clinical candidates. We have successfully developed a unique portfolio of high potential antibodies and believe that our drug candidates could revolutionize the treatment options for vision loss that occurs in orphan and non-orphan indications," she added.
About Ocular Disorders
Age-Related vision loss is dramatic and painful regardless of the type of diseases from which it manifests itself. The body's immune system, specifically the complement system, plays a role in many ocular disorders by causing inflammation & neovascularization which can lead to vision loss. Complement-mediated ocular destruction is now well documented in both Wet and Dry AMD and in other orphan and non-orphan disease indications. Current treatment options are limited and only control partial vision loss. The role of the alternative pathway in Dry-AMD is now becoming clear as illustrated by Roche's lampalizumab clinical trial results unveiled last month.
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 complement-mediated inflammatory and hemolytic disorders including Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), ocular inflammation and vision loss (Dry & Wet AMD), arthritis (RA & OA), 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. Roche/Genentech and Novartis are currently pursuing AMD trials.
NovelMed's proprietary technology for vision loss 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 Eye Institute of the National Institutes of Health.
Press Release Contact for NovelMed: Alexander McElroy, JD/MBA Senior Associate Tel: (216) 712 5854 Email: [email protected]