Health InsuranceAlcon Commences Phase 2 Clinical Trial Of NovaBay's NVC-422 For Viral Conjunctivitis
Alcon, Inc. (NYSE: ACL) and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY), announced that Alcon has begun treating patients in a Phase 2 clinical trial of NovaBay"s patented lead Aganocide® compound, NVC-422, for viral conjunctivitis, a type of "pink eye." Conjunctivitis is a pervasive and painful condition that affects both adults and children, leading to more than four million doctor and emergency room visits in the United States each year.
NovaBay has a licensing and research collaboration agreement with Alcon, the world"s leading eye care company, for use of its Aganocide® compounds in the eye, ear and sinus, and in contact lens solutions.
Developed by NovaBay to mimic the body"s defense against infection, Aganocides® are proprietary synthetic analogs of the same molecules used by white blood cells to destroy harmful microbes in the body, such as viruses and bacteria. Because of their natural mechanism of action, NovaBay believes that Aganocide® compounds have a low potential for generating microbial resistance, offering a potential solution to the problem of rising resistance of microbes to traditional antibiotics.
The Phase 2 viral conjunctivitis study follows a recently completed Phase 1 trial in which safety and tolerability were successfully demonstrated in 120 healthy volunteers with no reported serious adverse events.
"We are pleased to be entering mid-stage clinical testing for viral conjunctivitis," said Ron Najafi, Ph.D., chairman and chief executive officer of NovaBay. "This is the first step in the ophthalmic clinical development program for NVC-422, which has the immediate goal of developing the first effective product to address viral conjunctivitis for which there are limited treatment options."
The Phase 2 multi-center, randomized, placebo-controlled trial is designed to determine the safety and efficacy of NVC-422 in people with viral conjunctivitis. The study calls for enrolling approximately 250 patients at more than 30 medical centers, mostly in the United States.
"This study is an important step forward with the clinical program for this potentially dual-acting therapy to address the multiple causes of conjunctivitis. Dual action against viral and bacterial conjunctivitis is important because when an infection is diagnosed it is difficult, time-consuming and expensive to determine the underlying cause of the infection and treat it properly," said Dr. Sabri Markabi, M.D., Alcon"s senior vice president of research and development and chief medical officer.
About Conjunctivitis
Conjunctivitis, which can result from either viral or bacterial infection, is an inflammation of the thin, clear tissue that covers the white part of the eye and forms the inside lining of the eyelid. The viral disease is principally caused by adenoviruses, but also can be caused by other viruses, such as enterovirus. There is no specific treatment for adenoviral conjunctivitis, which can take up to three weeks or longer to clear on its own. Bacterial conjunctivitis is caused by a variety of bacteria and is largely treated with topically applied antibiotic eye drops. Regular innovation to develop newer antibiotics is required because over time antibiotics may encounter increasing bacterial resistance.
About Aganocide® Compounds
The Aganocide® compounds are novel, proprietary, synthetic N-chlorinated antimicrobial molecules specifically developed by NovaBay to mimic the body"s natural defense against infection. The Aganocide® compounds maintain the biological activities while improving the stability of naturally occurring N-chlorinated antimicrobial molecules. These highly differentiated compounds may deliver the same or better efficacy than currently used antibiotics without contributing to the growing rise of antibiotic-resistant bacterial strains. In preclinical testing, the Aganocide® compounds have been shown to be highly effective against bacteria, viruses and fungi. They also have been demonstrated to be effective against bacteria in biofilms, which render most antibiotics ineffective. Aganocides have a broad therapeutic index while providing a high degree of potency, good tolerability as well as dosing versatility and flexibility.
About Alcon
Alcon, Inc. is the world"s leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for more than 65 years, researches, develops, manufactures and markets pharmaceutical products, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. For more information on Alcon, Inc., visit the Company"s web site at http://www.alcon.com.
NovaBay Pharmaceuticals