Ocular Biopharmaceutical Company Charlesson Announces $1.6MM in New Funding and Upcoming Presentations at The Association for Research in Vision and Ophthalmology
Company aims to develop novel therapies to prevent blindness
OKLAHOMA CITY, April 21 // -- 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
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. For information about
Charlesson, see http://www.charlessonllc.com or contact:
Dr. Rafal A. Farjo
Director, Research and Development
Charlesson, LLC
800 Research Parkway, Suite 360
Oklahoma City, OK 73104
(405) 271-2557 Tel
(405) 271-2554 Fax
pr@charlessonllc.com
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