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NanoBio Launches Development Program for a Therapeutic Intranasal Vaccine for the Treatment of Hepatitis B

NIH Grant Supports Research of Nanoemulsion-based

Vaccine for Patients Previously Infected

ANN ARBOR, Mich. (April 19, 2010) - NanoBio® Corporation today announced an initiative to develop an intranasal vaccine for the treatment of hepatitis B (HBV). NanoBio and the University of Michigan’s, Michigan Nanotechnology Institute for Medicine and Biological Sciences received funding through a Phase 1 Technology Transfer (STTR) award by the National Institutes of Health (NIH), to evaluate a potential therapeutic intranasal vaccine for the treatment of hepatitis B in patients. This development program represents the first of several potential therapeutic vaccines in a significant extension of NanoBio’s vaccine platform.

Hepatitis B is an infection of the liver caused by the HBV virus. HBV is the most common cause of chronic viral liver disease worldwide. More than 370 million people are chronically infected with hepatitis B, leading to nearly one million deaths annually as a result of cirrhosis, and liver failure. HBV is transferred via bodily fluids and blood, and is commonly spread through sexual intercourse and intravenous drug use. Today, vaccinations are routinely given to infants to prevent infection contributing to lower rates of incidence in recent years. However, for patients previously infected, recurring infection is a concern that cannot be mitigated with existing vaccines.

“Currently available HBV vaccines are effective prophylactics, but lack therapeutic properties for those that are already infected,” said James R. Baker, MD, CEO and founder of NanoBio. “This new intranasal vaccine would have great value as a treatment to reduce the risk of HBV associated liver diseases and deaths globally. The vaccine is also highly stable at room temperature enabling storage without refrigeration, a factor of great importance in the developing world.”

Through this project, NanoBio and University of Michigan teams will demonstrate in animals the capabilities of a nanoemulsion-based HBV vaccine to safely induce immune responses in the presence of confounding factors such as kidney failure. This research is especially important as individuals with kidney function deficiencies are at high risk for complications of HBV infection when compared to normal individuals.

After successful completion of the preclinical studies funded by this STTR, NanoBio plans to conduct a FDA-approved Phase 1 clinical trial to evaluate safety, dose range, immunogenicity and preliminary efficacy against chronic HBV in humans with kidney failure.

About NanoBio’s Vaccine Platform
NanoBio’s nanoemulsion-based, intranasal vaccines have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcal, anthrax, smallpox and other diseases. The company’s NanoStat™ adjuvant platform technology has demonstrated numerous potential advantages over traditional vaccines, including: the ability to generate robust mucosal, systemic and cellular immunity; antigen-sparing qualities; cross-protection against non-vaccinated strains; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.

About NanoBio
NanoBio Corporation is a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat™ technology platform. The company’s lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis, acne, cystic fibrosis and a broad platform of intranasal vaccines. The company’s headquarters and laboratory facilities are located in Ann Arbor, Michigan.

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