MED/NEURO: Human trials of spinal nerve regeneration in ~1 year?

From: GBurch1@aol.com
Date: Sun Sep 12 1999 - 11:38:01 MDT


Anyone know more details about this outfit? A stock play?

http://dailynews.yahoo.com/h/nm/19990912/sc/health_israel_2.html

Sunday September 12 1:42 AM ET
Cell Therapy Shows Promise As Spinal Injury Cure
By David Rosenberg

JERUSALEM (Reuters) - Spinal cord injuries are responsible for one of the
human body's most frustrating phenomena -- they simply do not heal, leaving
victims permanently paralyzed as doctors stand by helplessly.

It was long a truism in the medical profession that the spinal cord -- part
of the central nervous system (CNS) that runs up and down the back -- could
never recover from injuries, with or without the help of drugs.

Some 11,000 people in the United States alone injure their spinal cords
annually. In the worst cases victims lose virtually all bodily functions
from the neck down.

But scientists are starting to revise their views and an Israeli start-up,
Proneuron Biotechnologies Ltd, is acting on them.

The three-year-old company is shunning conventional drug treatments in
favor of cell therapy in a treatment that shows promise not only in healing
spinal cord injuries but overcoming a host of other neurological diseases.

``It's really the Holy Grail to achieve spinal cord regeneration in
mammals,'' said Harry Rappaport, head of neurosurgery at Israel's Rabin
Medical Center.

Rappaport, who sits on Proneuron's scientific advisory board, said he knew
of only one other company in the world pursuing cell therapy as a means of
treating spinal cord injury.

Proneuron's answer to overcoming the spinal cord's stubborn refusal to heal
is to circumvent the central nervous system's ''immune privilege''
mechanism.

NATURAL MECHANISMS

``We deal with natural mechanisms. We're not introducing outside,
artificial molecules but we use cells to deliver a battery of natural
molecules mimicking the mechanisms of the human body,'' Valentin Fulga,
Proneuron's director of regulatory and clinical affairs, told Reuters in an
interview.

Adrian Harel, Proneuron company manager, said immune privilege apparently
evolved as a defense against diseases that might damage the CNS -- but it
also prevents injuries from healing.

``In the central nervous system, structure is very important for
function,'' he said. ``The connection between the nerves is very delicate;
once it's disturbed, its function is, too.''

Indeed, species with simpler neurological systems, like fish, can recover
from CNS injuries.
Proneuron's solution is to take a special type of white blood cells called
macrophages, which the body uses to repair injuries in other organs, and
put them to work in the spinal cord via a method developed by Michal
Schwartz, a scientist at the Weizmann Institute of Science and Proneuron's
chief scientist.

``Everywhere in the body macrophages are used for repair and healing,
except in the central nervous system, where they're very scarce and
ineffective, probably due to immune privilege,'' said Fulga.

To induce neuroregeneration, Proneuron takes macrophages from the victim's
blood, processes them in a special laboratory and then injects them into
the site of the injury. If effective, the treatment will take six to 12
months to show results.

There are two limitations to this therapy. The first is that there is a
window of two weeks from the time of injury where it can be employed; after
that the damage is irreversible, so that patients with older injuries
cannot be helped.

PARTIAL RECOVERY -- FOR NOW

The second is that Proneuron's therapy will not lead to complete recovery.
``We're sure we won't initially be able to grow 100 percent of the
nerves,'' said Harel. ``The outcome will be variable and depend on how much
physical therapy is done and other factors.''

To date, nerve regeneration has only been conducted on laboratory animals.
But Proneuron expects to begin phase one clinical trials on humans before
the end of the year, after the U.S. Food and Drug Administration gives the
go-ahead.

Proneuron has other, related technologies further up the development
pipeline.

A spinal injury victim often suffers only partial damage from the initial
trauma. A partial loss of feeling in the leg, for instance, may later
develop into full paralysis due to the damaging effect of the injured CNS
tissue on adjacent cells.

For this, Proneuron is in the early stages of developing another cell
therapy that makes use of T-lymphocytes -- white blood cells that help
create immune reactions -- to halt the process of secondary cell death that
often follows initial injury to the spinal cord or elsewhere in the CNS.

``As far as we know, no one is addressing this through cell therapy,'' said
Fulga, adding that the therapy could help treat glaucoma and even stroke.

Proneuron is also conducting early experiments with an immunosupressive
agent that could lead to treatments that halt neurological diseases like
Alzheimers, Parkinsons and multiple sclerosis.

The key is to uncover the structure of the natural Immune Privilege Factor
(IPF) molecule and re-produce it synthetically. That is very tricky and
will take much longer to develop than cell therapies.

``The molecule is tiny and has a tendency to degrade and disappear. When we
purify we often end up with almost nothing,'' said Harel, describing the
frustrations.

To speed up development in IPF, Proneuron hopes to enlist a major
pharmaceuticals company as a partner.



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