AtheroNova Signs Agreement for Development of Clinical Trial Supplies
Formulation Developer Now Working with First Clinical Compounding Project
25 Apr, 2012, 08:30 ET
IRVINE, Calif., April 25, 2012 /PRNewswire/ -- AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, today announced that it has signed an agreement with Frontage Laboratories, Inc. to commence work on the formulation, compounding and tabletization of the Company's AHRO-001 product in advance of the upcoming Phase I human clinical studies. Frontage, based in Exton, Pennsylvania, is one of the leading pharmaceutical contract research organizations (CROs) in the United States. They will immediately commence work on the analysis, formulation and validation of the various processes and procedures for manufacturing AHRO-001 tablets.
"Frontage has been extremely diligent in dealing with the technical and physical requirements of our AHRO-001 compound and we look forward to commencing our project in the coming days," said AtheroNova CEO Thomas W. Gardner. "We are very confident that Frontage will deliver a quality product in a timely manner. We continue to adhere to our vigorous development path and anticipate additional exciting development milestones in the coming months."
"We are pleased to be working with the fine people from Frontage on this project as we continue to engage with quality industry partners," commented Dr. Balbir Brar, Senior Vice President of Drug Development. "Our utmost confidence stems from previous projects I have worked on with Frontage and have always found their people, facilities and product quality to be some of the best in the industry."
Frontage CEO, Dr. Song Li, also commented on the agreement, stating "It is an honor to work with AtheroNova on this vital clinical trial materials project. Frontage's 10-year history of delivering pharmaceutical R&D services in a fast and efficient manner means the millions of patients suffering from atherosclerosis are that much closer to a potential cure."
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 pharmacological 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.
AtheroNova Inc., through its wholly-owned subsidiary, AtheroNova Operations, Inc., is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits. The Company's focus on compounds to reduce or regress atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention. www.AtheroNova.com.
About Frontage Laboratories, Inc.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform (GMP/GLP/GCP). Frontage runs three Phase 1 Clinical units, an 88-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. The Frontage CMC Division provide services in the areas of custom API synthesis and GMP manufacturing, analytical testing, formulation development and manufacturing of clinical trial materials including Sterile (Injection and Ophthalmic), Oral Solid (IR and CR), Topical, and High Potent products. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.
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 the Company's product shipments, suitability of the compound for its intended use, mechanisms of action, clinical trials and supply chain as well as 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.
Share this article