Nitric Oxide (NO) is a molecule of increasing interest in the medical world. NO is best known today as a potent vasodilator and is the end product of a number of drugs that collectively represented more than $55 Billion in 2005 pharmaceutical sales. Nitric Oxide has a number of other important physiological activities that are being studied in the academic medical community. Nearly 4,500 medical papers involving NO were published last year alone. Some of the properties identified in the literature concerning NO are:
· Broad spectrum anti-bacterial agent
· Anti-microbial activity against virus fungi and parasites (and bacteria)
· Activity against biofilms
· Activity against drug-resistant strains
· Anti-inflammatory actions
· Regulation of MMPs (including collagenase)
· Chemo-attractant for certain cell types
· Neurotransmitter
· Involvement in apoptosis
· Pro-angiogenic
· Increases blood flow.
Since NO is a regulatory molecule, different concentrations can have different effects. For example, at low concentrations NO is pro-inflammatory, while at higher concentrations it is anti-inflammatory. A significant challenge to getting the desired effect of Nitric Oxide is getting the correct concentration of the drug for a specific exposure.
Pulmonox Medical Inc., and later Viasys Healthcare Inc., began work on the use of Nitric Oxide gas (gNO). For topical use, a gas allows very tight control over the dose, especially since the half-life of Nitric Oxide in contact with tissue is only 6 seconds. Preliminary work on humans has been done in Canada under the Special Access Program.
On March 31, 2006, Nitric Bio closed on funding of $14.2M. The primary investors are Quaker BioVentures, New Spring Capital, Viasys Healthcare and a company related to Pulmonox Medical. Licenses were completed with Viasys and Pulmonox that granted exclusive rights to their patent portfolios for the topical use of gaseous Nitric Oxide.
Nitric Bio has two primary goals:
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Commercialization of an NO based product for wound care
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Quantification of the feasibility of our NO platform leveraging the NO attributes listed above.
Nitric Bio is a Delaware corporation based in Bristol, PA. Our offices are on the New Jersey/ Pennsylvania border convenient to dozens of pharmaceutical and bio-tech companies. The organization includes full-time and part-time employees and consultants. The team brings a wealth of wound care, clinical trial, regulatory, project management and reimbursement experience to the company.
Clinical work by Pulmonox Medical, mostly in association with Vancouver General and occasionally under the Canadian Ministry of Health Special Access Program, has led to the treatment of 15 patients with refractory non-healing wounds, all of whom had successful outcomes. That work is being continued in Phase II trials at a West Coast Medical Center, in Canada and a pending trial at a hospital center on the East Coast. A Phase III trial protocol has been submitted to the US FDA for comment.
Technology Overview Presentation
