Medesis Pharma Successfully Completes Phase I Clinical Trial of NP01

Press Release | 2010-05-31 | Read the full article

Medesis Pharma, the French based pharmaceutical company, announces the successful completion of a phase I clinical trial of NP01, a first in class anti-diabetic for the treatment of type 2 diabetes mellitus.

The objective of this randomised, double blind, placebo controlled study was to evaluate the tolerability of NP01 in healthy male volunteers following single and repeat administration of 180ug of the drug’s active ingredient, vanadium.

The company reported that there were no serious adverse events and that the drug was well tolerated both after single and repeat administration.

“We are very pleased with the favorable results of this phase I trial” stated Jean-Claude Maurel, President and CEO of Medesis Pharma. “These results will not only allow us to move forward rapidly into our phase II trials, but also show clearly that our delivery technology used in other products in our pipeline, is also well tolerated.”

About NP01

NP01 is a combination of the active ingredient, vanadium, and Aonys®, a novel reverse micelle delivery formulation. Vanadium has unique metabolic regulation properties providing both glycemic control and mixed lipid homeostasis. The insulin sensitising properties of vanadium have been widely documented over the past 25 years, but traditional oral formulations of vanadium have failed to provide sufficient benefit at non-toxic doses. NP01 provides significant improvements in vanadium cellular bioavailability affording efficacy at vastly lower doses of the active ingredient.

About Type 2 Diabetes Mellitus

Type 2 diabetes mellitus is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. By treating the underlying cause of type 2 diabetes; insulin resistance, long term glycemic control may be obtained.

About Medesis Pharma

Medesis Pharma is a clinical stage pharmaceutical company specialising in the development of a wide range of therapeutic agents based upon propriety Aonys® drug delivery technology. Aonys® is particularly applicable to metal and oligonucleotide active ingredients.