AtheroNova is a promising development stage biotech firm that grew up in California (Corporate HQ still in Irvine) and is now engaged, via wholly owned subsidiary AtheroNova Operations, in advancing a portfolio of pharmacological compounds. The company is currently focused on their lead offering AHRO-001, a powerful technological breakthrough in combating atherosclerotic plaque and safely improving overall lipid profiles.
We are talking about a breakthrough in a field that is today dominated by statin drugs and other, largely ineffectual lipid regulators or treatments, with the total market space encompassing everything from imaging and diagnostic catheterizations, to drug eluting stents and the like. Statins are really pretty ineffective at current dosage levels (more is dangerous) for reducing the buildup of plaques and yet they are also the most effective method on the market today for delimiting serum cholesterol levels and raked in some $37B in 2010 alone. Statins also have terrible long-term usage safety metrics and carry significant drawbacks in terms of basic tolerability, meaning that a pharmaceutical based on the AHRO-001 compound, which is from a class of compounds that have a demonstrably long history of safety and regulatory approval in humans, could be a real breakout innovation that impacts across the entire field. The ability to deliver the compound in a variety of ways, from parenteral, oral, and transdermal, to in-loco, also offers exceptional implementation dynamics that allow the drug more ubiquitous market access.
Atherosclerosis, or (mostly) cholesterol plaque buildup/hardening on the walls of arteries, hits big, with 90% of U.S. adults having over 10% blockage. Cardiovascular disease affects 1 in 3 Americans today. That's 85M people whose only options are ineffective statins, or really difficult to deal with stents, catheterization, and balloon angioplasties that don't even reduce the amount of plaque. There were 8M peripheral artery disease patients in the U.S. in 2011 alone (33% diabetics), another 7M stroke patients, 18M men suffering from erectile dysfunction, and 6M more suffering from Dementia and Alzheimer's. These numbers are staggering and account collectively for some 260M lipid-regulating drug prescriptions last year.
AtheroNova's key IP comes from the founding work by Dr. Giorgio Zadini and Dr. Filiberto Zadini, co-inventors whose work is now shielded by the U.S. Patent and Trademark Office, which issued a Notice of Allowance for one of AHRO's main patent applications (July 9), covering the AHRO-001 compound's proprietary method for treating Atherosclerosis with a bile acid (naturally occurring bile acid, hyodeoxycholic acid, or HDCA). Basically we have a compound here that utilizes an established, safe vector for delipidizing the artery wall very rapidly by permeating the atherosclerotic fibrous cap and dissolving the composite material. In addition to widening the artery, this method averts rupturing/dislodging of plaque chunks that can lead to serious cardiac events, and AHRO also believes that further work will show that the delipidized artery walls will experience significant restoration of initial integrity as inflammation subsidizes.
AtheroNova is in the pole position moving forward for regression/stabilization of plaque through this technology and is well-positioned to capture significant space in with what is potentially going to become the gold standard for treatment in the sector. The licensing agreement signed in late 2011 with major Russian biotech fund, the Maxwell Biotech Group's wholly-owned subsidiary, OOO CardioNova, to cover not only funding for Phase I-II human clinical trials in Russia, but also eventuating in direct market access to the massive Russian Federation, Ukraine, and various central Asian countries covered by the agreement, is a sweet deal for AHRO shareholders. The USPTO approval, alongside the Phase I-II clinical trialing campaign, adds serious weight to the recent success of preclinical study work completed in conjunction with UCLA and Cedars-Sinai, set to be published in the respective scientific journals (later this year by UCLA and in early 2013 by Cedars-Sinai). The CardioNova deal alone should result in impressive quarterly royalties on net sales over the full lifespan of the IP in that massive market and the global impact of a true statin alternative that also actually gets the job done safely should be enough to pique the interest of potential investors.
This technology also has abundant potential to strike out into new territory, with delipidization of subcutaneous fat being a primary target the company has developed IP for. This function has already been identified by research at top U.S. academic institutions in one of the compounds AHRO has determined to be effective and the potential for burning fat via localized transdermal delivery has, to say the least, exciting profit potential. It is important to stress the overall viability of delipidization and its effect on health and well-being. Given the safety of the compound and its effectiveness, we could be looking at the emergence of new general indication for delimiting lipid buildup throughout the body's vast network of small peripheral vessels.
Presentations at the recent 2012 Aegis Capital Healthcare Conference (Sept 28) and Rodman & Renshaw 14th Annual Healthcare Conference (Sept 11), have left a lasting impression on the sector, with the incredible near-term potential of the leading AHRO-001 compound, the UCLA study data, and the company's strong development pipeline all making a significant impact. The company is poised to validate the extant, very encouraging preclinical data with human clinical trials. The compound potential reaches across entire market segments and the absence of negative toxicological effects in the preclinical work accentuates the historically validated safety of this compound class in humans. AHRO-001 should be in Phase I by Q4 2012 and early next year we should see AHRO meeting again with FDA, as they did back in 2011, to clear the way for Phase II work and a U.S. IND filing.
For more information on this exciting young biotech firm, please visit the company's website located at: AtheroNova.com
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