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NovelMed Awarded NIH Fast Track SBIR Grant for $1.43 Million to Advance Development of its Anti-Complement Antibody for Orphan Disease
Date:9/9/2013

CLEVELAND, Sept. 9, 2013 /PRNewswire-USNewswire/ -- NovelMed Therapeutics (www.novelmed.com) announced the receipt of a combined $1.43 million SBIR Grant from the NIH. The first installment of the award (for $542,572) will be used to evaluate NovelMed's lead candidate's therapeutic superiority for treating Paroxysmal Nocturnal Hemoglobinuria (PNH).  Subsequent funding, to be released on demonstration of superiority, will be used for later stage development.  The NIH award represents a major step toward commercialization of the Company's orphan disease therapy platform.

(Logo: http://photos.prnewswire.com/prnh/20130909/DC73243LOGO )

The grant follows strong evidence from recent studies that its lead candidate will block intra- and extra-vascular hemolysis, both of which must be controlled in order to gain advantages over eculizumab. These studies indicate that NovelMed's lead candidate could have a superior efficacy, safety and dosage profile relative to eculizumab.  The project will compare the two therapies under various experimental conditions.

"As a small business we applaud the support of the NIH in transitioning promising technologies from the laboratory to the clinic. We are honored that the scientific peer-review process at the NIH has repeatedly deemed our developmental concepts worthy of continued support as we advance the development of life-changing products," stated Rekha Bansal, Ph.D., Founder and Chief Executive Officer of NovelMed.

About PNH

PNH is a rare and life-threatening blood disorder where the immune system attacks red blood cells resulting in significant disease outcomes including red blood cell destruction and long-term anemia. Current treatment options are limited and only control cell destruction via the intravascular pathway. Despite staggering success of the current complement inhibitor being marketed, some patients continue to remain anemic due to the second newly-discovered pathway for red blood cell destruction also known as "extravascular hemolysis". NovelMed's leading drug candidate prevents red blood cell destruction via both pathways and therefore is expected to provide significant benefit in the total control of anemia.

About NovelMed

NovelMed Therapeutics, Inc., a privately-held biotech located in Cleveland, Ohio, is developing transformative treatments for orphan and non-orphan disease conditions.  The company has developed a portfolio of antibodies targeted for the treatments of complement-mediated inflammatory and hemolytic disorders including paroxysmal nocturnal Hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), age-related macular degeneration (Dry & Wet AMD), arthritis (RA & OA), and cardiovascular diseases.  NovelMed's drug candidates are differentiated by their unique mechanism(s) of action that are expected to deliver therapies with superior efficacy, safety and dosage profiles. The company is currently looking for strategic partners for clinical trials and commercialization of its therapeutic drugs.

Similar drug discovery is being pursued by a few companies including Roche/Genentech and Novartis, which are both pursuing AMD therapies, and Alexion which is currently marketing Soliris (eculizumab), an FDA approved antibody-based therapy.

Disclaimer

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 Heart, Lung, and Blood Institute of the National Institutes of Health under award number R44HL115909.  


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