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Biotech / Medical : AutoImmune-AIMM
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To: Regis McConnell who wrote (47)3/19/1997 7:39:00 AM
From: Daniel Goncharoff   of 298
 
From the recent 10K:

AutoImmune has received Orphan Drug designation for Myloral.

Approximately 350,000 persons in the United States suffer from MS, of

which approximately 45% have relapsing/remitting MS. The patients in the Phase

III pivotal trial of Myloral suffer from relapsing/remitting MS. Approximately

one-third of individuals with MS stabilize and never reach a severe stage;

others have multiple acute attacks as frequently as two to three times a year.

In its most severe form, the disease is relentlessly progressive and can result

in complete disability within ten years. Since the early 1980s, non-specific

immunosuppressants, such as cyclophosphamide and azothioprine, have been used

with occasional success to slow the progression of this disease in some

patients. None of

-6-



these treatments is capable of stopping MS attacks or halting the progression of

the disease without exposing patients to potentially serious side effects. Since

1993, three products have been approved by the FDA for the treatment of

relapsing/remitting MS. All three are indicated for reduction of the frequency

of MS exacerbations (one is also approved for slowing the progression of

disability associated with MS). Each of these drugs is administered by injection

and each has side effects, including injection site reactions and flu-like

symptoms or shortness of breath.
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