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:6/26/2016)... June 27, 2016  VMS Rehab Systems, Inc. ( ... take whatever measures required to build a strong and ... is currently listed on the OTC Markets-pink current trading ... and CEO, "We are seeing an anomaly in market ... not only by the Company, but shareholders and market ...
(Date:6/24/2016)... 2016  Consumers have taken a more active ... more emphasis on patient outcomes. ... the pharmaceutical industry have evolved beyond just providing ... are focusing on becoming more patient-oriented across their ... services that improve health. ...
(Date:6/24/2016)... June 24, 2016  Global Blood Therapeutics, Inc. (GBT) ... developing novel therapeutics for the treatment of grievous ... the closing of its previously announced underwritten public ... the public offering price of $18.75 per share. ... offered by GBT. GBT estimates net proceeds from ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, ... remain in the eye of the beholder, according to experts who offered insights and ... Journal of Managed Care. For the full issue, click here . , For ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Pixel Film Studios ... X. , "Film editors can give their videos a whole new perspective by using ... - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different ...
(Date:6/26/2016)... NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and ... to be personalized through a fitness app. The fitness app plans to fix the two ... currently only offer a one size fits all type program , They don’t ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts ... applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention ... health care topics including advance care planning, healthcare costs and patient and family ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
Breaking Medicine News(10 mins):