Navigation Links
NanoBio Corporation Announces Positive Phase 1 Clinical Results for,Topical Treatment for Onychomycosis

ANN ARBOR, Mich., May 22, 2007 /PRNewswire/ -- NanoBio Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of serious infections, today announced positive safety data from its Phase 1 clinical study of NB-002, the company's drug candidate currently in a Phase 2 clinical trial for the topical treatment of onychomycosis.

The Phase 1 clinical study was completed in January 2007 and involved 20 subjects who received twice-daily treatments of NB-002 (0.25% or 0.5%) for 28 days. Subjects were examined on days 1, 3, 7, 14, 28 and 58 for adverse events, dermal irritation and pharmacokinetic sampling. There were no drug- related adverse events, serious adverse events or discontinuations due to adverse events in any of the subjects treated. In addition, plasma drug levels were below the limit of detection (1 ng/mL) at all time points. Based on the remarkable safety profile demonstrated in this clinical study as well as other previously conducted clinical and toxicology studies, a 42-week double-blinded Phase 2 clinical study of NB-002 was initiated by NanoBio in the first quarter of 2007.

James R. Baker, MD, NanoBio's Chairman of the Board and Chief Science Officer, commented, "A unique aspect of products derived from the company's NanoStat(TM) technology is that the treatments are not systemically absorbed and they are selectively toxic to microbes while non-irritating to the skin and mucous membranes. This Phase 1 safety data further confirms that NB-002 will offer a safe alternative to the currently available systemic products. This is a critical factor for individuals affected by onychomycosis, given approximately 95% of people with this disease remain untreated as a result of the serious toxicities associated with the oral medications on the market."

Phase 2 Clinical Study for NB-002

A randomized, double-blinded, placebo-controlled Phase 2 c linical study is currently being conducted by NanoBio to evaluate the efficacy and safety of three-dose regimens of NB-002 in the treatment of distal subungual onychomycosis. One thousand potential patients are being recruited in order to enroll 400 subjects at 22 sites in the United States and Canada. An interim analysis of planimetry data is planned for December 2007 after 160 of the subjects have completed 24 weeks of treatment. A final analysis of planimetry and complete cure data is anticipated in the second quarter of 2008 after all subjects have completed 42 weeks of treatment. Patient enrollment for the study is currently ahead of schedule.

About Onychomycosis

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. In the US, onychomycosis affects 25% of adults, including 40% of those over 50 years of age. The global market for onychomycosis treatments is anticipated to grow to $3.6 billion by 2010. Systemic treatments represent well over 80% of the market today, but have potential severe liver toxicity issues, and have shown to have relapse rates of 40% or higher. The only approved topical treatment for onychomycosis has demonstrated a low efficacy rate ranging from 5% to 12%.

About NanoBio Corporation

NanoBio(R) Corporation (http://www.nanobio.com) 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, Michigan.

CONTACT: John Coffey, Vice President, Business Development,+1-734-302-9107, john.coffey@nanobio.com

Web site: http://www.nanobio.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Alfacell Corporation to Present at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
2. Millipore Corporation Announces New ReNcell Data from Collaboration with ReNeuron
3. Alba Therapeutics Corporation Reports Preliminary Phase IIa Clinical Trial Results for AT-1001 for the Treatment of Celiac Disease
4. EpiCept Corporation to Present New NP-1 Data at American Pain Society Meeting
5. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
6. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
10. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
11. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... , Feb. 11, 2016 Brain Cancer ... treatment method at West Cancer Center . ... fields to inhibit cancer cell replication causing death of ... than a decade to show a significant extension in ... (GBM) patients. Currently, West Cancer Center is the only ...
(Date:2/11/2016)... , Feb. 11, 2016  AbbVie, a ... AbbVie Rheumatology Scholarship, designed to provide financial support ... as they pursue higher education goals. Fifteen scholars ... the 2016-2017 school year. The AbbVie Rheumatology Scholarship ... Haas , vice president, corporate social responsibility, brand ...
(Date:2/11/2016)... 11, 2016 PLAD, Inc. (OTC Pink: PLAD) is ... sales exceeding company targets, are adding key personnel to ... from the United States Patent and Trademark Office for ... Executive Officer of PLAD, Inc.  In January, PLAD established ... with two new customers, Cumberland Goodwill EMS ...
Breaking Medicine Technology:
(Date:2/11/2016)... New Jersey (PRWEB) , ... February 11, 2016 , ... ... to a free CEU seminar titled, “Stroke Management: Time to Act, Time to Heal” ... Housing Community in Whippany, N.J. The presenter is Vishal Chedda, president of ANSA ...
(Date:2/11/2016)... ... February 11, 2016 , ... The president released a ... Health System but would shift more of the cost burden to military beneficiaries. ... laid out in the defense budget as including limited quantifiable benefit fixes mixed with ...
(Date:2/11/2016)... ... February 11, 2016 , ... In a new ... plastic surgeon , Dr. Rod J. Rohrich, and colleagues, examine and underscore the ... recommendations for rhinoplasty surgeons when addressing this vital area. , The upper lateral ...
(Date:2/11/2016)... ... February 11, 2016 , ... PharmMD CEO ... Garrett will focus on contract negotiations, corporate strategy and healthcare data law. Additional ... best practices in data breaches for the Part D Star Rating improvement and ...
(Date:2/11/2016)... ... 11, 2016 , ... Talix today announced that Clive Fields, ... presenting at the 2016 HIMSS Annual Conference & Exhibition, taking place February 29 ... “ Coding for Care: Using Data Analytics for Risk Adjustment ,” Dr. Fields ...
Breaking Medicine News(10 mins):