Navigation Links
Replidyne Announces Positive Phase I Results for Topical Antibiotic REP8839

Replidyne, Inc. today announced results from three Phase I trials studying REP8839, a novel topical antibiotic that has shown potent in vitro activity against major skin pathogens including methicillin-resistant S. aureus (MRSA).

The results of the Phase I trials show that topically applied REP8839 appears safe, well-tolerated and associated with low systemic exposure, or drug absorption into the bloodstream, which is desirable for a topical antibiotic treatment. Based on these results, Replidyne plans to initiate Phase II trials in children with impetigo, the most common bacterial skin infection, by the end of the year.

"REP8839 is a promising development candidate and has the potential to be an important treatment option for physicians in the ongoing fight against drug-resistant infections including MRSA, a growing public health concern," said Kenneth J. Collins, Replidyne's President and Chief Executive Officer. "With these safety data, we intend to move forward into Phase II trials to study the safety and efficacy of REP8839 in patients with impetigo and other skin and wound infections."

REP8839 was tested in three Phase I trials which collectively enrolled over 400 subjects. In the first Phase I trial, safety, tolerability and skin irritancy were tested following repeated daily application of REP8839, at three drug concentrations (1%, 2% and 4%), on intact and abraded skin. Irritancy scores comparable to placebo were recorded for all REP8839 exposed test subjects.

In the second study, in addition to safety, tolerability and dermal irritancy, systemic exposure was examined following repeated daily application of REP8839 on a larger surface area of intact and abraded skin. In all subjects, REP8839 was associated with low systemic exposure and low skin irritancy.

In the third study, a 2% formulation of REP8839 was tested for its ability to cause long-term sensitization and irritancy. No sensiti zation reactions were recorded in any of the subjects, and low irritancy potential was confirmed. Additionally, in all Phase I studies no serious adverse events were observed in any study subject.


'"/>




Related medicine news :

1. Ramdoss Announces Introduction of RCH-II
2. Britain Announces Third Transfusion Related Mad Cow Case
3. Tibet Announces the Dalai Lama’s Tour of South Americ
4. Indian PM Announces Of Setting Up India Study Center At Tashkent
5. PowderMed Announces Needle-Less Flu Vaccine
6. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Australian Government Announces Survey To Tackle Childhood Obesity
9. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
10. Apollo Announces Research on Indian Cardiac Epidemic
11. Government Announces Steps To Promote Ayurvedic Medicine
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... News Issue 52" report to their offering. ... influenza treatment creates a favourable commercial environment for MedImmune to ... patient base that will serve to drive considerable growth for ... would serve to cap sales considerably, but development is still ...
(Date:6/23/2016)... MOUNTAIN VIEW, Calif. , June 23, 2016 ... 9:00 a.m. CST on Thursday, July 7, 2016 , , ... kayla.belcher@frost.com ) , , , , EXPERT PANELISTS:  ... Sciences, Nitin Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, ... The global pharmaceutical industry is witnessing ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: