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Company aims to develop novel therapies to prevent blindness
Charlesson LLC, an ocular biopharmaceutical company, today announced that it is the recipient of two Small Business Innovative Research (SBIR) awards from the National Institutes of Health (NIH). The two grants total approximately $1,600,000 and will support development of a nanoparticle-formulated therapy for eye disease as well as commercialization of a preclinical genetic animal model for Age- Related Macular Degeneration (AMD). Dr. Rafal Farjo, Director of Research and Development at Charlesson, is principal investigator on both grants.
Mike Moradi, Chief Executive Officer of Charlesson said, "We are proud to be NIH's partner in success. These competitive grant awards demonstrate the national enthusiasm for our development activities and the success of Charlesson's ongoing research program." Since its inception in 2003, Charlesson has received 11 grants from the NIH. "We are also pleased to receive our first SBIR grant that will aid in the development of Charlesson's preclinical services division to provide outsourced ophthalmic research and development. In addition, these funds will greatly assist the company in expanding our scientific team and finalizing preclinical studies for an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)," said Mr. Moradi.
Charlesson was awarded $210,357 in a Phase I SBIR award from the NIH to validate and commercialize a genetic mouse model of AMD. "An unmet need currently exists for a reliable genetic model of AMD that can be used to assess the efficacy of AMD-therapeutics in development. There are only a few genetic mouse models which have been reported to present with features of AMD, but this phenotype only develops at very late ages. Therefore, a genetic, reproducible, economical, and quantifiable mammalian AMD model is of great significance to aid in the development of new drugs. The goal of this project is to develop this new AMD model for contract services to screen ophthalmic drugs for other pharmaceutical companies," said Dr. Farjo. "This Phase I grant will use several known anti-angiogenic drugs to demonstrate the proof-of- principle for the utility and efficiency of using this model as tool for drug development." Charlesson is also utilizing this AMD-model to develop anti- inflammatory, anti-angiogenic, and neuroprotective efficacy profiles for its own drug candidates. "In addition to providing our scientists with an excellent tool to establish efficacy of Charlesson's therapeutics, there is a tremendous market to perform contract research services for AMD drug development. We are excited at the potential to add this unique and powerful model to Charlesson's preclinical service offerings," said Mr. Moradi.
Charlesson also received $1,388,677 in a Phase II SBIR award from the NIH to develop CLT-004 for treating AMD, Diabetic Retinopathy (DR), and Diabetic Macular Edema (DME). These funds will be used to develop IND-enabling efficacy, safety, and toxicity profiles. CLT-004 is a small molecule therapeutic with potent effects on reducing retinal inflammation and vascular leakage. Charlesson is developing a sustained release nanoparticle formulation of CLT-004 to treat blinding retinal disease. "Our core philosophy is that inflammation and vascular leakage in the retina are early pathogenic components that cause retinal neovascularization, which is the underlying culprit in many forms of retinal disease. Inhibition of retinal inflammation and vascular leakage has thus become a new target for pharmaceutical intervention in DR and AMD," said Dr. Farjo. "Our preclinical studies have demonstrated that CLT-004 has potent effects on these endpoints and represents the next generation in therapeutics to treat DR and AMD. This Phase II project will continue our studies to determine the efficacy of this novel compound on the expression of inflammatory factors, leukostasis and retinal vascular leakage in animal models of diabetes and AMD. In addition, we have packaged the compound into nanoparticles to promote stability and sustained efficacy."
"We believe that the application of nanotechnology to drug delivery will allow us to reduce the interval of dosing to patients suffering from AMD and DR. Current therapies require an intraocular injection every 4-6 weeks. Our novel nanoparticle formulation scheme may allow us to reduce this interval to 12-16 weeks," said Mr. Moradi. "We expect to file our first IND on CLT-003 in 2008 and anticipate a second IND-filing for CLT-004 in 2009. We are hopeful that Charlesson's products will improve the quality of life for the millions of Americans suffering from these blinding diseases." Dr. Ronald A. Wassel, Senior Scientist at Charlesson, will present the company's progress in nanoparticle-based drug delivery at the ARVO 2008 conference in Ft. Lauderdale, FL. Dr. Wassel will present in a special workshop group focusing on Nanotechnology and Nanomedicine for ophthalmic applications. Charlesson scientists are also presenting four other poster presentations detailing the company's drug development progress. For a full list of presentations and schedule, please visit http://www.charlessonllc.com/ARVO2008
Charlesson also announced that Dr. Mostafa Analoui has joined as Senior Vice President of Business Development. Dr. Analoui was previously the senior director at Pfizer Global Research and Development in Connecticut. "We are excited to add Dr. Analoui to our team at Charlesson. His wealth of expertise in drug development will be of great value to Charlesson as we move towards our first in man studies with our lead compounds," said Mr. Moradi.
About Diabetic Retinopathy and Macular Degeneration
Diabetic Retinopathy is the one of the most common complication of Diabetes and a leading cause of blindness in developed countries. Almost 100% of patients with type I and 60% of type II diabetic patients will develop some degree of retinopathy in their lifetime. Approximately 10% of diabetic patients develop a severe visual handicap after 15 years of diabetes. Retinopathy in diabetic patients is often preceded by Diabetic Macular Edema where vascular leakage leads to swelling of the retinal tissue. There are currently no FDA-approved treatments for treating DME.
Age-related Macular Degeneration (AMD) is a rapidly growing retinal disease which primarily affects patients of age 50 years and older. Current prevalence rates in the US estimate that over 15 million citizens are afflicted with this disorder; however, as a consequence of the rapidly growing aging population, it is predicted that prevalence rates will increase 50% by 2020. "Charlesson's drug development portfolio represents new advances in the development of AMD-therapeutics", said Dr. Farjo. "Existing therapies for AMD solely inhibit the abnormal formation of blood vessels in the eye. Recent evidence suggests that inflammation is also a key pathogenic feature of AMD. Charlesson's approach is to develop therapies that inhibit both neovascularization and inflammation to produce a stronger therapeutic benefit."
About Charlesson LLC
Charlesson LLC is actively engaged in the development of therapeutics for treating numerous ocular diseases. The company's product pipeline includes pharmaceutical treatments for Age-Related Macular Degeneration, Retinitis Pigmentosa, Leber's Congenital Amaurosis, and diabetic complications, such as Diabetic Retinopathy and Diabetic Macular Edema. Charlesson is also developing novel strategies to enhance drug delivery to the eye. In addition, the company offers outsourced preclinical services for the pharmaceutical industry, to screen drug candidates in the Charlesson's novel animal and cell models for ocular disease. The company's clients include Fortune 500 companies and growth-phase biopharma companies worldwide. Charlesson was founded in 2003.
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Dr. Rafal A. Farjo
Director, Research and Development
800 Research Parkway, Suite 360
Oklahoma City, OK 73104
(405) 271-2557 Tel
(405) 271-2554 Fax
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