AtheroNova establishes clear development plan for AHRO-001 after positive FDA feedback

Dec 15 2011

AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque has established a clear development plan, including Phase I and Phase II protocol outlines, based on the recently finalized minutes of its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) for its AHRO-001, a compound for the treatment of atherosclerosis.  The Company has incorporated guidance from the FDA and is moving forward with its IND enabling activities.  In addition, the sourcing and production of the Active Pharmaceutical Ingredient (API) is progressing according to schedule. 

"As a result of the supportive feedback from the FDA, we have established a clear development plan for AHRO-001, including Phase I and Phase II human clinical studies." said Thomas W. Gardner, CEO of AtheroNova.  "Based on the success of our interactions with the FDA, AtheroNova plans to move forward with the submission of the IND application during 2012, as planned." 

"The imaging of plaque lesions has made significant strides in the last few years and AtheroNova is planning to use the state of the art combination of intravascular/near-infrared spectroscopy as a critical measurement tool for the regression of coronary artery disease when moving forward with its Phase I and Phase II studies," said Balbir Brar, DVM, PhD; SVP, Drug Development of AtheroNova.  "Critical information of the coronary plaque morphology and lipid content will assist in the measurement of clinical progress of this and future therapies in plaque management.  We appreciate FDA's suggestions in AtheroNova's study outlines and acceptance of intravascular/near-infrared spectroscopy use in evaluating plaque reversibility."

SOURCE AtheroNova Inc.