Thursday, August 19, 2010

Clinical trial of Droxidopa

Chelsea Therapeutics Announces Initiation of Investigator-Led Phase II
Study of Droxidopa (Northera)  in Chronic Fatigue Syndrome

CHARLOTTE, N.C., Aug 19, 2010 (GlobeNewswire via COMTEX) -- Chelsea
Therapeutics International, Ltd.
/quotes/comstock/15*!chtp/quotes/nls/chtp (CHTP 3.59, +0.04, +1.13%)
announced that a new investigator-led phase II clinical study of
Droxidopa, an oral synthetic precursor of norepinephrine, has been
initiated in chronic fatigue syndrome (CFS).

CFS is a complex and crippling disorder characterized by extreme
fatigue that is not improved by rest. In addition to fatigue, patients
with CFS experience symptoms, similar to that of fibromyalgia
including, weakness, muscle pain, impaired memory and concentration.
Droxidopa has been shown to improve symptoms of fatigue, weakness and
concentration in neurogenic orthostatic hypotension associated with a
variety of conditions including Parkinson's disease, multiple system
atrophy and pure autonomic failure. Droxidopa is also being studied in
an ongoing Phase II trial in fibromyalgia
where, during an interim
analysis, an independent data monitoring committee saw meaningful
efficacy in multiple treatment arms.

Dr. Charles Lapp, a former board member of the American Association
for CFS and medical advisor to the American Fibromyalgia Syndrome
Association, is conducting this single-center Phase II study at the
Hunter-Hopkins Center in Charlotte, North Carolina. The trial will
evaluate up to 600 mg TID of droxidopa
and assess the clinical
efficacy using changes in Patient Global Impression of Improvement
(PGI-I). In this open-label trial, approximately 20 patients will be
titrated to optimal therapeutic benefit over a two-week period after
which they will continue treatment for 12 weeks. The primary outcome
measure will be changes in PGI-I scores from baseline to the end of
the 12-week treatment period. Secondary measures include changes in
the Multidimensional Fatigue Inventory (MFI), Clinical Global
Impression of Severity (CGI-S), Hospital Anxiety and Depression Scale
(HADS), blood pressure before and after a tilt table test.

"As we continue to work towards an approval for droxidopa for the
treatment of neurogenic orthostatic hypotension, we are eager to
expand the body of clinical research supporting potential indications
that could be effectively treated with norepinephrine replacement
therapy," said Dr. Simon Pedder, president and CEO of Chelsea. "We
welcome the opportunity to support Dr. Lapp's efforts to characterize
the therapeutic role of norepinephrine in chronic fatigue syndrome and
believe that a favorable outcome from this study, combined with data
being generated by our ongoing Phase II trials in fibromyalgia and
adult attention deficit hyperactivity disorder, will further highlight
the integral role of norepinephrine as a neurotransmitter central to
the etiology of a host of disorders."

About Droxidopa

Droxidopa, the lead investigational agent in Chelsea Therapeutics'
broad pipeline, is currently in Phase III clinical trials for the
treatment of symptomatic neurogenic orthostatic hypotension (NOH) in
patients with primary autonomic failure -- a group of diseases that
includes Parkinson's disease, multiple systems atrophy (MSA) and pure
autonomic failure (PAF). Droxidopa is a synthetic catecholamine that
is directly converted to norepinephrine (NE) via decarboxylation,
resulting in increased levels of NE in the nervous system, both
centrally and peripherally. Droxidopa is also being studied for the
treatment of fibromyalgia and adult attention deficit disorder in two
ongoing phase II trials and completed a phase II in intradialytic
hypotension (IDH) study with positive results.

Chelsea Therapeutics is a biopharmaceutical development company that
acquires and develops innovative products for the treatment of a
variety of human diseases. Chelsea's most advanced drug candidate,
Northera(TM) (droxidopa), is an orally active synthetic precursor of
norepinephrine initially being developed for the treatment of
neurogenic orthostatic hypotension. In addition to Northera, Chelsea
is also developing a portfolio of metabolically inert oral antifolate
molecules engineered to have potent anti-inflammatory and anti-tumor
activity to treat a range of immunological disorders, including two
clinical stage product candidates: CH-1504 and CH-4051. Preclinical
and clinical data suggest superior safety and tolerability, as well as
increased potency versus methotrexate (MTX).

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