In the News
Novatans work to develop antibiotic super-bugs can’t beat
By Paul Jones
Staff Writer
Wednesday, July 16, 2008 2:05 PM PDT
But siblings Ron and Kathryn Najafi, a pair of Novato-resident researchers, aren’t just looking for new drugs to fight the growing problem; they’re developing an entirely new class of anti-bacterial compound from scratch.
Not entirely from scratch, actually. The compound created by Ron’s company, NovaBay in Emeryville, is based on chemicals already produced by the human body’s white blood cells. Called “aganocides,” the reactive chemicals work as antiseptics, dissolving offending microbes without damaging human tissue. Because they destroy bacteria physically, rather than just poisoning them, even the most virulent microbes can’t develop resistance to the chemicals. And because aganocides also have anti-viral properties, they could even be useful fighting the replication of viruses.
“Just as we took penicillin out of mold, we’ve taken aganocides out of white blood cells,” said Ron Najafi, who said the inability of bacteria to develop resistance against the immune system had drawn him to study the chemicals it used as an alternative to antibiotics. “In general, antiseptics are very toxic, but our bodies are able to handle the ones produced by white blood cells. By studying their structure, we’ve created a synthetic compound that has similar characteristics, and is safer, and will last (in storage) longer.”
Due to the reactive nature of aganocides, Najafi said his company and its partners were currently focused on creating superficial applications, such as eye-drops, nasal sprays, and ointments that could be applied outside the body to reverse or prevent infection. The compound has been demonstrated to be highly effective against Methicillin-resistant staphylococcus aureus, or MSRA, an often-lethal bacterium resistant to multiple antibiotics. Its potential attracted the interest of a number of larger companies.
“We’ve licensed the rights for these compounds, our patents, to Alcon,” he said. “They will be using it for eye, ear and sinus application … Kinetic Concepts Incorporated is also developing an antibacterial application for open wounds and sores. We’re looking at potentially doing some work in the United Kingdom, with the Common Cold Institute, testing on nasal formulation against the viruses.”
However impressive its current degree of corporate interest would suggest, attracting developers required first demonstrating the extent of the compound’s application. While an effective bacteria killer, tests were needed to demonstrate its safety. It was Kathryn Najafi, an ophthalmologist and CEO of the Marin Eye Institute in San Rafael, who helped design and run an early test that suggested the safety of the drug in a broad range of medical applications.
Najafi was gaining experience in New York when she found out about the compound her brother had been working with. Committed to opthomology, she said she was immediately interested in its application in treating diseases of eye, which can be the most difficult to cure, and the most disabling, due to the eye’s complex structure and vital function.
“I was in New York at the time, and (Ron) was really looking at the treatment of non-healing wounds, advanced wounds that don’t heal,” she said. “I looked at the clinical trials, and saw that patients who hadn’t responded to other treatments were responding very well. And at the same time, I was noticing more and more patients in emergency rooms with eye infections, and they were drug-resistant types, very difficult to treat.”
Najafi decided to work with her hospital and her brother to test the compound’s safety treating infections in some of the most vulnerable –and delicate– tissues in the human body. The simplest testing environment to determine the drug’s safety in a broad swath of applications? The eye.
“I wanted to see if I could work with my brother to use this compound to treat diseases in the eye,” she said. “I got permission from my hospital to do a study to test its effectiveness on rabbit’s (ocular) diseases and it turned out, sure enough, that it was effective and relatively free of harmful side effects.”
The test involved rigorous protocols designed to eliminated bias and ensure accurate results, said Najafi.
“It was a Draize test,” she said. “It was a double blind study, so I didn’t know if what I was putting in was the medicine or the placebo …The test was primarily to make sure that the compound did no harm. We knew from the data from other studies that it was affective against bacteria.”
After Ron pursued a second, independent test to confirm Kathryn’s results, the siblings had demonstrated not only the effectiveness of the molecule, but its viability as a potential treatment for literally hundreds of infections.
“If you can put something in your eye, you can put it on an open sore. The eye has all these exposed mucus membranes,” said Najafi. “There are huge potential applications. All these resistant infections in hospitals, we’re headed towards finding a drug to fight against them … Basically, it’s a dream come true for me.”
With the new data, NovaBay also had the information it needed to attract interest from drug developers, which carry the enormous costs of testing and marketing new drugs.
“The rabbit eye is similar to our eyes, structurally,” said Ron. “So with the test results, we had something we could show Alcon, which became very interested … Almost all of the eye-drug companies were looking at it, and Alcon wanted to make the deal with us quickly. It was an $80 million deal, and we received 10 million up front.”
Ron said with multiple companies now working on different applications, the single chemical could become a first line of defense against an emerging generation of super-bugs.
“We’re going to be engaged in clinical testing, hopefully before the end of this year, for a spray for Nasal MSRA, which is a huge problem. And we’re also developing a treatment for urinary tract infections, that trial is ongoing,” he said.
Letter from Dr. Najafi-Tagol to Patients
September 15, 2008
Dear Patients and Friends,
I am Dr. Kathryn Najafi-Tagol, your Ophthalmologist. It is my great pleasure to announce that based on anonymous consumer nominations I have been selected as the best ophthalmology doctor in Marin County by viewers of KRON 4 TV’s “Best of the Bay”. KRON 4 has never before recognized an ophthalmologist on its “Best of the Bay” program and here at the Eye Institute of Marin we feel honored to have been chosen for this distinction. Our entire team considers it a great privilege to care for you and we are grateful for the confidence and trust you place in us.
Please tune in to KRON 4’s upcoming feature on the Eye Institute of Marin on Saturday, Sept. 20th at 5:30 pm, and again on Wednesday, Sept. 24th at 1:30 pm. Let your friends and family know that our patients have voted us “Best of the Bay.” You may also view the press release on our web site.
I would like to take this opportunity to keep you apprised of some of the advances in ophthalmology that directly relate to your ability to improve your vision. Based on our commitment to patient education we have developed a new web site, www.eyeinstituteofmarin.com, full of useful information about your eye health.
One of the greatest advances we have seen in eye care today is in the treatment of cataract, a debilitating condition that causes a gradual blurring of vision. Cataract is the most common treatable cause of vision impairment, and recent advances have greatly reduced the need for patients to wear corrective glasses after surgery. Until recently, patients undergoing lens implant surgery received a monofocal or single focus IOL ( IntraOcular Lens) implant. Monofocal IOLs implanted in both eyes generally provide excellent distance vision; however, patients often need spectacle correction for near vision or astigmatism. Today’s more advanced premium IOLs are designed to provide multiple points of focus, reducing the need for spectacles and thereby enhancing vision and quality of life.
The most recent advancement in cataract surgery with lens implantation is the accommodating Crystalens®, which allows for both distance as well as intermediate vision correction. We have also had great success with use of ReSTOR® multifocal IOL, which corrects both distance and reading vision. Alternatively available is Alcon’s TORIC® IOL, which corrects astigmatism at the time of cataract surgery, again reducing the need for wearing corrective glasses.
Annual screenings as well as early detection and treatments are critical to preventing vision loss. Our state-of-the art equipment combined with our expertise enable us to detect and treat serious eye conditions. Glaucoma, for example, is a common eye disease that can cause vision loss and blindness but often goes undetected because there are no outward symptoms. Eye exams are the only way to detect glaucoma. Since glaucoma is a hereditary condition you should inform your family and loved ones of the importance of a thorough ophthalmic examination to screen for glaucoma after age 50. The American Academy of Ophthalmology also recommends a baseline screening at age 40, when signs of glaucoma and vision changes begin to occur.
To better serve our patients and to offer timely appointments, Dr. Jeffrey Guild and Dr. Antonio Moran, our Optometrists, will continue to work with me in the clinic. Both Dr. Guild and Dr. Moran have extensive experience in eye care and are uniquely qualified to care for your general eye health, refraction for glasses and contact lens fitting. They are valued members of our team.
Our team is dedicated to advanced medical, surgical, and laser treatment of a variety of eye conditions, providing full service from annual eye exams to LASIK vision correction for nearsightedness and farsightedness. We offer free consultations to determine your suitability for laser vision correction. Please call our office at 415-444-0300 to schedule an appointment.
Over the years, patients have given us the compliment of referring family and friends to our practice. Your confidence in our care motivates us to continue to strive for excellence. Thank you for your referrals. Your continual trust and support are greatly appreciated.
Best Regards,
Kathryn Najafi-Tagol, M.D.
KRON4's "Best of the Bay"
Press release coming soon. Please check back.