| Shingles (MIV-606)
After causing childhood chickenpox, VZV (varicella zoster virus) remains
latent in nerve tissues, held in check by the immune system. It remains
there until the immune system is compromised, perhaps as a consequence of
stress, illness or just old age. At such times, the virus may reactivate
causing shingles particularly in the elderly and presenting as a painful
strip of vesicles, usually around the trunk, with the risk of severe,
chronic pain and persistent after-effects.
Shingles stings and itches on and under the skin, and at times, the pain
is intense. After a few days, a rash becomes apparent as a band or
collection of small vesicles on the body, which in the most severe cases,
appear on the face, affecting the trigeminal nerve, which ends under the
eye. Because of the risk of complications such as compromised sight or
hearing, people suffering from shingles on the face should seek medical
help quickly, and other sufferers should do so to reduce the risk of
chronic pain. 50% of all shingles patients are affected by chronic pain of
varying severity.
The irritating vesicular eruptions develop into small water-filled
vesicles, and at their peak, out-breaks can vary from mild irritation to
extreme, in-tense pain. Eventually, the vesicles heal leaving small scabs,
and some five weeks after the first symptoms, all the pain from the
vesicles disappears, with the skin free from blemishes. However, many
sufferers experience protracted pain, lasting up to several years.
Post-herpetic Neuralgia
VZV causes childhood chickenpox, and then remains latent in the nervous
tissue. It may reactivate in later life, resulting in shingles with the
ensuing chronic pain, called PHN (post-herpetic neuralgia). The nervous
system is involved in shingles, with more serious and complex symptoms
than chickenpox. The pain is a consequence of the virus causing nerve
tissue damage, generating additional nerve impulses, and thereby, pain.
The damage causes chronic pain that is extremely hard to treat, although
regular pain-killers do help. The pain is often disabling and can result
in disturbed sleep, weight-loss and depression.
A Shortage of Drugs
VZV causes shingles outbreaks on 3.5 million sufferers in the West each
year, with as many as 95% of the world’s adult population carrying VZV.
The risk of contracting shingles increases with age.
Current antiviral pharmaceuticals include acyclovir and valaciclovir,
which exert an effect on the vesicles that erupt, but only a marginal
effect on chronic pain. A broad selection of analgesic drugs and pain
killers are used against the chronic pain, with varying results.
MIV-606
Medivir’s theory is that a substance exerting a good effect on shingles
would have to be far more potent than current drugs and would have to
quickly reach the nerve cells that VZV damages, thereby causing PHN.
MIV-606 is 100-400 times more powerful than existing pharmaceuticals and
can also reach the nerve tissue. The drug would have to be administered as
soon as the symptoms become apparent but with greater awareness of how
shingles symptoms are expressed, the better the chances of successful
medication.
Heading for Phase III
MIV-606 has passed through clinical phase II with positive results.
Discussions with forthcoming partners are in a conclusive phase regarding
outlicensing ahead of the phase III program, which is the next step for
MIV-606.The objective of these phase III trials is to verify MIV-606’s
effect on chronic pain. At present, there is no drug registered for this
indication.
MIV-606 is also active on other herpes viruses such as HSV, which causes
cold sores and genital sores, and the Epstein-Barr virus, which causes
mono-nucleosis, more commonly known as glandular fever. Moreover,it is
active against HHV-6 (herpes virus type 6) which may be involved in MS. |
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MIV-606 Against Shingles
– Activities in 2001
Development of a large-scale production synthesis method
Optimization of tablet formulation
Evaluation of tablet against suspension
in clinical phase I trials with positive results
No toxicological effect on reproduction
demonstrated in preclinical trials
Preparatory work ahead of phase III
trials underway
Efforts to identify a partner for phase
III trials now nearing completion
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