Navigation Links
New Topical Therapy Safely Treats Serious Skin Infections Without Systemic Side Effects
Date:9/19/2007

ANN ARBOR, Mich., Sept. 19 /PRNewswire/ -- A new topical lotion that penetrates the skin deeply enough to target and eliminate serious skin infections, but without being systemically absorbed, has shown a high degree of safety and tolerability in patients with onychomycosis, or toenail fungus, a new study has shown.

"Results of the phase 1 clinical trial are important to the fields of dermatology and infectious diseases because currently approved systemic medications for onychomycosis carry serious risks of cardiac and liver toxicity," said James Baker, MD, chief science officer and founder of NanoBio Corporation in Ann Arbor, Mich. NanoBio scientists developed the lotion.

The phase 1 data for the new lotion, NB-002, will be presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, to be held Sept. 17 -20, 2007, in Chicago.

"At present, the vast majority of people with onychomycosis are untreated as a result of concerns for the serious toxicities associated with the available oral medications," said Baker. "Our safety data, combined with early information from the ongoing phase 2 trial, indicate that NB-002 is potentially the first treatment for onychomycosis that is highly efficacious and very safe."

NanoBio Corporation is a spin-off from the University of Michigan. The company develops novel anti-infective products and mucosal vaccines to treat or prevent a wide range of infections, from cold sores and toenail fungus to influenza and hepatitis B. Its lead products are NB-001 to treat herpes labialis and NB-002 to treat onychomycosis.

NB-002 is a topical oil-in-water nanoemulsion combined with an antimicrobial agent commonly used in oral products to treat gingivitis and other conditions of the mouth and throat. The nanoemulsion undergoes a high- energy process to shrink or "nano-size" the particles so they are small enough to enter the skin through pores and hair follicles but too large to penetrate the tight junctions of the epithelium.

As a result, NB-002 is not systemically absorbed, as the phase 1 study has demonstrated. In the study, 20 subjects with advanced onychomycosis were randomized to receive two strengths of NB-002. Treatments were applied twice daily for 28 days to both affected and unaffected toenails and a small area of surrounding skin. Blood samples were collected periodically to determine if the drug was absorbed systemically.

Results showed the drug was below the quantifiable limit of systemic absorption for all subjects throughout the study period. Additionally, the trial showed that, unlike the current treatments for onychomycosis, NB-002 had no safety or dermal irritation concerns.

Results of a phase 2 clinical trial for onychomycosis are expected in early 2008.

In addition to its topical agents, NanoBio is developing a rich pipeline of needle-free vaccines based on using the same oil-in-water emulsion technology as an adjuvant. Mucosal vaccines against influenza and hepatitis are scheduled for human testing beginning next year, while an anthrax vaccine has demonstrated safety and strong efficacy in animal studies.

About NanoBio

NanoBio(R) Corporation is a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat(TM) technology platform. The company's lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), methicillin-resistant Staphylococcus aureus (MRSA) and mucosal vaccines for influenza and hepatitis B. The company's headquarters and laboratory facilities are located in Ann Arbor, Mich.

NanoBio Presentation

Poster presentation M-1819, Tolerability, Safety and Pharmacokinetics of Topical Nanoemulsions (NB-002) in Patients With Onychomycosis, is scheduled for Session #188, 9/19/2007, at 12:15 - 4:00 pm, Title: Antifungal Drugs.


'/>"/>
SOURCE NanoBio Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Replidyne Announces Positive Phase I Results for Topical Antibiotic REP8839
2. NanoBio Corporation Announces Positive Phase 1 Clinical Results for Topical Treatment for Onychomycosis
3. Apollo develops needle-free topical vaccine
4. Helix BioPharma Corp. Announces Positive Phase II Clinical Results with its Topical Interferon Alpha-2b
5. Gene Chips to Detect CYP Variations: A New Step Toward Customized Medical Therapy.
6. Breast Cancer and HER-2/neu: Diagnostic Tools for Targeted Therapy
7. Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
8. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
9. YM BioSciences Announces Preclinical Data Confirming Nimotuzumab Binds to the EGF Receptor and Potentiates Radiotherapy
10. Response Genetics Announces Publication of a Phase III Clinical Trial Demonstrating That Low Levels of ERCC-1 Help to Predict Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer
11. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... SAN FRANCISCO, Calif. , Jan. 16, 2017 /PRNewswire/ ... that on January 3, 2017 and January 16, 2017 ... the grant of inducement stock options to purchase an ... new employees. These awards were granted pursuant to the ... inducement material to the new employees entering into employment ...
(Date:1/16/2017)... , Jan. 16, 2017 CBDRx, the world,s ... amounts of phyto-nutrient rich hemp extract to Veteran,s groups ... of their proprietary hemp extract to Veteran,s groups across ... best hemp company in the world and through their ... nutritious, full spectrum phyto-nutrient rich hemp extract available. ...
(Date:1/15/2017)... 16, 2017 Le conseil d,administration de ... de collagène pour la régénération de tissus humains, annonce la ... directeur général avec effet immédiat. ... Bill est un dirigeant expérimenté à ... postes de gestion générale et de direction au sein de ...
Breaking Medicine Technology:
(Date:1/16/2017)... , ... January 16, 2017 , ... ... been appointed Chief Executive Officer of the medical device company, effective immediately. , ... Robert Storey. “Kevin has a strong track record in medical device market ...
(Date:1/15/2017)... ... 2017 , ... Going above and beyond the practical impact ... communities around the world by offering the Gensuite team and their services to ... members to become involved in a cause that is bigger than themselves and ...
(Date:1/15/2017)... ... 15, 2017 , ... "On Tour is a music themed slideshow production package ... Christina Austin - CEO of Pixel Film Studios. , On Tour’s new slide ... and animation of their slideshows. Place each slide on top of another slide or ...
(Date:1/15/2017)... ... January 15, 2017 , ... The Gravity Vault Indoor Rock Climbing Gym is ... wraps up on the 14,000+ square foot climbing gym, the owners anticipate to open ... in New Jersey and two in New York. With this being its first location ...
(Date:1/14/2017)... ... January 13, 2017 , ... According to a ... Mediterranean diet may lower the risk of type 2 diabetes, Alzheimer’s, and cardiovascular ... health and wellness benefits linked to a Mediterranean diet are only some of ...
Breaking Medicine News(10 mins):