Clinical Trials:

NB-001 demonstrated clear efficacy and safety in randomized, double-blind, placebo controlled Phase 2a and Phase 2b studies involving over 800 subjects with recurrent herpes labialis. 

In the Phase 2b study of 482 patients, NanoBio's targeted Phase 3 topical dose healed patients 1.3 days faster than placebo as measured by investigators (p=0.006). This highly statistically significant efficacy is at a magnitude comparable or superior to what has been reported for the leading systemic herpes treatment products on the market today. 

In both the 2a and 2b trials, NB-001 was well-tolerated with no safety concerns or adverse events, and was not systemically absorbed. NanoBio will enter Phase 3 testing in 2010.

Viral Lysis and Low Potential for Resistance:

NB-001 employs a physical mode of action to disrupt the outer envelope and prompts viral lysis, essentially killing on contact.

This rapid physical mode of action significantly reduces the likelihood that resistant herpes virus strains

will develop. 

NB-001 has demonstrated potent antiviral activity in vitro against HSV strains that have shown resistance to other antiviral agents to include acyclovir and foscarnet. 

Market Position, NB-001:

It is anticipated that NB-001 will rapidly capture market share from all Rx and OTC current therapies, as well as dramatically expand the market by offering the significant number of untreated sufferers a viable treatment option. Safety, efficacy and the low potential for the development of resistant strains makes NB-001 an ideal OTC product.   

In December 2009, NanoBio Corporation and GlaxoSmithKline, plc (GSK) announced an exclusive licensing agreement in the United States and Canada for the over-the-counter (OTC) use of NB-001, a novel, patented compound representing the next advance in the treatment of herpes labialis (cold sores). GSK plans to build on its Abreva brand with the future launch of NB-001. 

About Herpes Labialis:

Cold sores or fever blisters on the lips or surrounding skin are predominantly caused by the Herpes simplex I (HSV1) virus.  Approximately 80% of all Americans are infected with HSV1 and approximately 20% to 40% of adults suffer from recurrent outbreaks of cold sores.  While not life-threatening, these attacks can be painful and unsightly, and are highly contagious.