[Medinox/NSAID prodrug]
Designed to address the same concerns as COX-2 inhibitors, I'm not clear on the rationale for MX-1094. If there is rationale, the upside could obviously be pronounced. Discussion and relevant citations are solicited. Aside..... as of May, 19 of 60 patients had enrolled in the NOX-100 trial.......
Wednesday June 5, 6:01 am Eastern Time
Press Release
SOURCE: Medinox, Inc.
Medinox Initiates Phase 1 Safety Trial of MX-1094, An NSAID Prodrug for the Treatment of Arthritis
SAN DIEGO, June 5 /PRNewswire/ -- Medinox, Inc. announced today the start of a Phase 1 safety trial of MX-1094, an NSAID prodrug in development for the treatment of arthritis. The trial is being conducted in The Netherlands and is scheduled for completion by the end of 2002.
The trial is a randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study. The primary endpoint of the trial will be to evaluate the initial safety profile, tolerability and pharmacokinetics of MX-1094 in healthy volunteers.
Medinox's NSAID prodrug program is addressing the need for safer and effective NSAIDs. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs such as aspirin, naproxen and diclofenac) are an important class of analgesic and anti-inflammatory compounds that are among the most widely used medicines in the world. Despite their proven clinical efficacy and wide use, NSAIDs have limitations, especially for patients undergoing long-term NSAID therapy. The main problems are upper gastrointestinal (GI) adverse events that are a frequent side effect of NSAID therapy and are responsible for 107,000 hospitalizations and 16,500 deaths annually in the US.
MX-1094, a novel NSAID prodrug based on naproxen, has demonstrated proof of concept in pre-clinical studies. In addition, MX-1094 has shown the same efficacy profile as the NSAID drug from which it was derived.
"We are excited about moving forward into clinical development with this promising new compound," said Monte Lai, Medinox's President and CEO. "We believe that MX-1094 will meet the need for safer NSAIDs and has the potential to be a leading clinical therapy."
About Medinox, Inc.
Medinox is the leader in nitric oxide (NO)-blocking therapeutics and is developing a broad technology platform to treat a wide variety of unmet medical needs including, sepsis, diabetes, adult respiratory distress syndrome (ARDS), and arthritis. Including the initiation of the MX-1094 trial, Medinox currently has three clinical trials in progress. NOX-100, Medinox's injectable NO blocker, is being evaluated in a multicenter Phase 1/2a clinical trial for the sepsis indication. NOX-700, Medinox's orally active NO blocker, is being evaluated in a Phase 1 clinical trial for diabetes. In addition to its NO blocker and NSAID prodrug technologies, Medinox is also developing new therapeutics for sickle cell anemia.
For information on Medinox, please visit the company's website at www.medinox.com .
This press release contains forward-looking statements, which reflect the Corporation's current expectation regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors. The reader is cautioned not to rely on these forward-looking statements. The corporation disclaims any obligation to update these forward- looking statements.
SOURCE: Medinox, Inc. |
