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

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NanoBio Launches Development Program for a Therapeutic Intranasal Vaccine for

the Treatment of Hepatitis B

From the PharmaLive.com News Archive - Apr. 19, 2010

NIH Grant Supports Research of Nanoemulsion-based Vaccine for Patients

Previously Infected

ANN ARBOR, Mich.--(BUSINESS WIRE)--Apr 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 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.

Contact: NanoBio Corporation

Coffey, 734-302-9107

Vice President, Business Development

john.coffey@...

or

Schwartz Communications

Stacey Holifield/ Navon, 781-684-0770

nanobio@...