Navigation Links
FDA Agrees With AtheroNova's Clinical Development Plan as Proposed
Date:12/14/2011

IRVINE, Calif., Dec. 14, 2011 /PRNewswire/ -- 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."

About AHRO-001

AHRO-001 is AtheroNova's first novel application for the treatment and prevention of atherosclerosis. Atherosclerotic plaque is the primary, underlying cause of heart disease and stroke in industrialized countries. AHRO-001 uses certain natural compounds to regress atherosclerotic plaque deposits through a process known as delipidization. Delipidization dissolves plaques in artery walls, which are then removed by natural body processes. AtheroNova plans to develop multiple applications for its patents-pending compounds that can be used in pharmaceutical-grade products for the treatment of atherosclerosis. Atherosclerosis and related pharmaceutical costs run more than $41 billion annually in the United States alone. Market sectors potentially served by AHRO-001 include: Cardiovascular Disease, Stroke, Peripheral Artery Disease, Dementia and Alzheimer's and Erectile Dysfunction, all of which have been linked to atherosclerosis.

About AtheroNova

AtheroNova, through its wholly-owned subsidiary, AtheroNova Operations, Inc., is a development stage company currently researching novel patents-pending applications of certain natural compounds to regress atherosclerotic plaque deposits, a process called delipidization. The Company plans to develop multiple applications for its compounds, to be used in pharmaceutical grade products for the treatment of atherosclerosis, obesity and lipomas.

Forward-Looking Statements

Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward looking statements in this news release include statements regarding FDA guidance, filing of an IND application, clinical measurement of plaque using intravascular/near-infrared spectroscopy and Phase I and II clinical studies, and the development of applications for AtheroNova's technology. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in AtheroNova's filings with the United States Securities and Exchange Commission. AtheroNova undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE AtheroNova Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Zimmer Holdings, Inc. Agrees to Sell $550 Million of Senior Notes
2. 1-800-GET-THIN Agrees With Report Calling for Better Eating Habits
3. ARAMARK Agrees to Sell its Galls Business to CI Capital Partners
4. Valeant Pharmaceuticals Agrees to Acquire Ortho Dermatologics
5. Valeant Pharmaceuticals Agrees to Acquire Dermik
6. BioMarin Agrees to Acquire Biologics Manufacturing Plant in Ireland from Pfizer
7. Devicor™ Medical Products, Inc. Agrees to Acquire Neoprobes Gamma Detection Devices
8. Biofield Corporations 51% Owned Subsidiary Agrees to Deal Appointing McKinley Infocapital as Korean Exclusive Distributor of Breast Cancer Diagnostic System; Contract has Potential Value of up to $15.3 Million
9. Quest Diagnostics Agrees to Repurchase 15.4 Million Shares From Largest Shareholder
10. Xanodyne Agrees to Withdraw Propoxyphene From the U.S. Market
11. Boston Scientific Agrees to Sell Neurovascular Business to Stryker
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)... 2017  Eli Lilly and Company (NYSE: ... operations to more efficiently focus resources on developing ... Global workforce reductions, including those from a U.S. ... approximately 3,500 positions. With the ... of approximately $500 million that will begin to ...
(Date:9/7/2017)... BOTHELL, Wash. , Sept. 7, 2017   BioLife ... developer, manufacturer and marketer of proprietary clinical grade cell and ... media ("BioLife"), announces that Mike Rice , President and ... Rodman & Renshaw 19 th ... 3:25 p.m. Eastern time (12:25 p.m. Pacific time). The conference ...
(Date:9/6/2017)... 2017 Eli Lilly and Company (NYSE: ... data for galcanezumab and lasmiditan, two investigational treatments for ... Society (IHC) taking place Sept. 7-10 in ... new, long-term data from an open-label study evaluating the ... mg and 240 mg) for the prevention of migraine. ...
Breaking Medicine Technology:
(Date:9/21/2017)... , ... September 21, 2017 , ... With ProSlideshow Portrait ... and easy to do. Users can select from up to two layers of subject ... click of a mouse all within Final Cut Pro X. , With ...
(Date:9/21/2017)... Church, VA (PRWEB) , ... September 21, 2017 ... ... FDAnews Webinar**, Sept. 26, 2017 — 1:30 p.m. – 3:00 p.m. ET, ... business. It’s easy to get things wrong, run afoul of The Quality System ...
(Date:9/21/2017)... ... September 21, 2017 , ... The American Addiction Treatment ... for professionals in the addiction treatment industry entitled: Special Investigations Unit (SIU) ... companies and state and federal governments are increasingly scrutinizing the addiction treatment industry ...
(Date:9/21/2017)... ... September 21, 2017 , ... ... of a new member survey conducted by the International Society of Hair ... from 2014 to 2016 rose 60 percent, with 635,189 procedures performed in 2016. ...
(Date:9/21/2017)... San Diego, Ca (PRWEB) , ... September 21, 2017 , ... ... and affordable services to its customers, and give back to the community. For over ... on of the most successful companies serving plumbing in San Diego. They ...
Breaking Medicine News(10 mins):