First anti-virus drug a breakthrough
By Larry Bush
‘An advance comparable to the discovery of penicillin. ’
The first safe, effective drug to successfully treat death-dealing herpes simplex enchephalitis, was approved for marketing Tuesday by the U.S. Food and Drug Administration.
Developed in Ann Arbor at the Warner-Lambert, Parke-Davis laboratories, it was hailed last year as “an advance comparable to discovery of penicillin” following nationwide tests.
Called adenine arabinoside and labeled with the trade name Vira-A, the injectable form of the drug reduced deaths from the viral brain infection from 70 to 28 percent in the tests.
IT WILL BE marketed for treatment of herpes simplex enchephelaitis beginning in December, according to H.L. Richardson Jr., president of the Warner-Lambert, Parke Davis Pharmaceutical Division.
But Vira-A was previously approved by the FDA in December, 1976, for non-injection use in treating hepetic keratis, a serious eye disease, following clinical testing by Dr. Roger F. Meyer, University of Michigan ophthalmologist, and others.
The drug has also been undergoing testing by scientists in the U-M Dental Research Institute and College of Pharmacy since 1975, in addition to testing at the Parke-Davis laboratories.
Dr. Nathaniel H. Rowe, associate director of the U-M institute, said Tuesday that “Vira-A was found effective in the proper vehicle (ointment) in reducing the size of oral lesions, or cold sores” in recently completed tests with faculty, staff and students.
HOWEVER, results of the just completed study have not been published, and FDA approval for marketing for that purpose has not yet been applied for.
Testing of the drug for viral brain infection was conducted under auspices of the National Institutes of Health. And, in addition to showing the large reduction in mortality, the tests of Vira-A also showed that more than 50 percent of the survivors treated had no or only moderate effects from the illness.
Donald Kennedy, FDA commissioner, said Tuesday that everyone connected with development of the drug “can take pride.”
“The dramatic reduction of death, in a formerly fatal disease marks a major development in medicine,” he said.
“Approval of this drug is particularly noteworthy because it holds out the hope that some day we will be able to successfully treat other viral diseases.”
Dr. Robert Buchanan, Parke-Davis director of clinical research, said, “Since this is the first parental injectable anti-viral drug, this means virus infections can now be treated with drugs or chemicals.
“WE HAVE ALL been taught in the past that there is no drug that can treat viral infections. But now we have one.
“The second implication is that now that a drug can be used, second and third generation compounds already being identified in our laboratories can be developed, and we will see many other infections succumb to drug therapy.”
Vira-A has been under study since 1962, when a culture was isolated from a soil sample collected in Italy. Initial testing of the drug was done at the Ann Arbor laboratories on Plymouth Road, after possible anti-viral action was picked up at the Parke-Davis fermentation laboratories in the Detroit area.
Labeled 9-B-D - arabino-furanosyladenine by Parke - Davis chemists, the drug has already saved the eyesight of many persons afflicted with hepetic keratis, one of the leading causes of blindness.
NOW IT promises to save the lives of many more who contract the brain infection. The FDA estimates that at least 1,000 people in the U.S. suffer from the disease at any given time.
Reports that the drug held promise of conquering the common cold that followed NIH-sponsored testing last year were termed erroneous by scientists.
Parke Davis & Co.
Pharmaceuticals - Research & Development
Food and Drug Administration (FDA)
University of Michigan Dental Research Institute
University of Michigan College of Pharmacy
National Institute of Health
Ann Arbor News
H. L. Richardson Jr.
Roger F. Meyer
Nathaniel H. Rowe