|From: betone||6/4/2001 11:16:48 PM|
|Monday June 4, 4:05 pm Eastern Time|
Miravant to Start Clinical Trials of New Topical PhotoPoint Drug for Dermatology
SANTA BARBARA, Calif.--(BW HealthWire)--June 4, 2001--Miravant Medical Technologies (Nasdaq:MRVT - news) announced today that it will start phase I clinical trials to test the safety of its proprietary new PhotoPoint(TM) drug, MV9411, for diseases of the skin. The photoselective drug is prepared in a topical gel formulation that penetrates the skin for potential treatment of conditions such as psoriasis, actinic keratoses (pre-cancerous lesions caused by sun-exposure), persistent warts and skin cancers. PhotoPoint photodynamic therapy (PDT) uses a light-activated drug in combination with low power, non-thermal light to target diseased cells and blood vessels.
Gary S. Kledzik, Ph.D., chairman and chief executive officer stated, ``I am very proud that Miravant's chemistry pipeline has produced a second PhotoPoint drug for human clinical trials. This is a noteworthy accomplishment given the rigors of new drug development.''
The phase I clinical trials, which have received U.S. Food and Drug Administration (FDA) clearance, are expected to start later this month. In the drug-only study, various doses of MV9411 will be applied to the skin of 20 healthy volunteers, who will be followed for one month to evaluate the drug's safety.
If the safety results prove acceptable, Miravant plans to initially investigate PhotoPoint PDT to treat plaque psoriasis, a chronic condition for which there is no known cure. In this disease the epidermis proliferates as much as 10 times the normal rate, resulting in inflamed and scaly skin plaques. Mild to moderate plaque psoriasis affects an estimated 5 million Americans, with over $2 billion dollars spent each year for outpatient treatments.
Miravant has photoselective treatments now in development for several broad disease markets. The company's first PhotoPoint drug, SnET2, licensed to Pharmacia Corporation in 1996, is currently in phase III clinical trials for the treatment of wet age-related macular degeneration (wet AMD), a leading cause of blindness. PhotoPoint SnET2 is being developed for wet AMD under an exclusive, worldwide license that gives Pharmacia the rights to manufacture, use, distribute and sell SnET2, returning royalties to Miravant on gross sales. Other unique PhotoPoint drug compounds are in preclinical development for restenosis and atherosclerosis in cardiovascular disease and for solid tumors in oncology.
Miravant Medical Technologies specializes in both pharmaceuticals and devices for photoselective medicine. The company is developing its proprietary PhotoPoint PDT in ophthalmology, dermatology, cardiovascular disease and oncology.
The statements above about the start of phase I clinical trials in June 2001, the potential to treat a variety of skin disorders, and the plans to investigate PhotoPoint PDT for plaque psoriasis are forward-looking, and relate to our future plans, objectives, expectations and intentions. Our actual results may differ materially from those described in these statements. For instance, the occurrence of one or more of the following may cause our results to differ from our plans: The anticipated start of phase I clinical trials may be delayed, the company may not be able to complete the enrollment and one-month safety evaluation of 20 healthy volunteers in the phase I clinical trials, safety results for the drug MV9411 may be unacceptable or inconclusive, the FDA may not allow the company to commence clinical trials to treat plaque psoriasis or other skin diseases or may require additional testing before initiating these clinical trials, the PhotoPoint drug MV9411 may not prove useful for treating plaque psoriasis or any other skin disorders and our understanding of the market opportunities and market size for plaque psoriasis may vary substantially from our estimates. For a discussion of additional important risk factors that may cause our results to differ from those set forth in our forward-looking statements, please refer to our annual report on Form 10-K for the year ended December 31, 2000 and other quarterly and periodic reports filed with the Securities and Exchange Commission.
For more information please visit our web page at: www.miravant.com
Miravant Medical Technologies
Tom Herrick, 805/685-9880
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|To: betone who wrote (1)||10/21/2004 1:20:40 PM|
|Eye doctor warns about alternative medicines|
Some herbal and vitamin supplements can cause serious vision side effects, a Casey Eye Institute researcher says
Wednesday, October 20, 2004
Some popular herbal and vitamin medicines -- including ginkgo biloba, echinacea and niacin -- can have side effects that harm vision, an Oregon Health & Science University researcher has found.
For years, Dr. Rick Fraunfelder has logged reports of drugs accidentally harming the eyes through his National Registry of Drug-Induced Ocular Side Effects, based at OHSU's Casey Eye Institute. With U.S. residents increasingly using alternative therapies, Fraunfelder decided to search for related reports of vision damage.
He turned up 323 accounts of vision problems linked to alternative medicines, especially to eight common supplements. About one-fifth of U.S. residents use some sort of supplement, according to the national Centers for Disease Control and Prevention.
"Herbal medicines are regarded by the general public as natural and therefore safe. Nothing could be further from the truth," said Fraunfelder, an ophthalmologist. "There's all types of bad reaction you can get from these herbal products."
He noted that herbal remedies do not face the same federal safety tests that drugs must pass. Some herbal products have poor quality control and may contain little -- or too much -- of their main ingredients. And users can harm themselves by taking large doses or by not telling their physicians about alternative therapies, which can interact with medicines the doctors advised using.
For example, Fraunfelder found several reports of ginkgo biloba causing eye bleeding, including retinal hemorrhages that can scar the eye's inside lining. Ginkgo biloba thins the blood, and people who take it with aspirin or other blood thinners are at greater risk for such reactions, Fraunfelder said.
Individual biology plays a role in deciding who suffers side effects. But problems generally tended to increase with higher doses of the alternative therapies, or when the therapies were put directly in the eye, Fraunfelder said.
Other side effects, reported this month in the American Journal of Ophthalmology, include:
Swelling of part of the retina, decreased vision, dry eyes and other problems from niacin use.
High blood pressure within the eyes and skull after high doses of vitamin A.
Conjunctivitis, or "pink eye," from the use of echinacea -- which is secreted in tears when swallowed. Teas made from chamomile or euphrasia, also called "eyebright," also can cause pink eye when used as eye drops.
Temporary vision loss from licorice, which can clamp blood vessels shut, as in a migraine headache.
Long-lasting pupil dilation, which can eventually lead to a form of glaucoma, from jimson weed.
Buildup in the retina of crystals of canthaxanthine -- a carotenoid used to artificially tan -- which can interfere with tests of eye health.
Not everyone who uses these therapies will have the side effects, Fraunfelder said. And some of the therapies have proven benefits, such as niacin's ability to improve cholesterol levels.
Fraunfelder said people who are using alternative therapies should tell their doctors. And people with eye problems should see an ophthalmologist, he said.
People older than 40 should see an ophthalmologist every two to four years, he added, with visits every year or two after age 65.
Andy Dworkin: 503-221-8239; email@example.com
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