Repligen Corporation (NASDAQ:RGEN) announced the initiation of a phase I/II trial of RG2133, a prodrug of uridine, in patients with either bipolar disorder or major depression.

   In addition to standard clinical evaluations of safety and efficacy,
the trial will evaluate potential changes in brain chemistry by magnetic
resonance spectroscopy (MRS).

   The trial is being carried out by investigators at McLean Hospital,
a teaching affiliate of Harvard Medical School, and McLean's Brain Imaging
Center, Massachusetts.  The open-label trial will evaluate oral administration
of RG2133 in 20 patients.

   "Uridine therapy is a novel approach to the treatment of bipolar disorder
and major depression" stated Andrew Stoll, MD, director of the Psychopharmacology Research Laboratory at McLean Hospital.  "We need new approaches for these patients whose disabling and life- threatening symptoms are not adequately treated with existing therapies."

   The phase I/II trial is based on pre-clinical animal studies conducted
by researchers at McLean demonstrating that uridine is active in a well-validated animal model of depression.  The clinical trial will assess the impact of RG2133 on the depressive symptoms associated with bipolar disorder and with unipolar major depression, neither of which is adequately treated with existing drugs including SSRIs such as Prozac or Zoloft, according to Repligen. In both diseases, evidence from MRS suggests that there are imbalances in the levels of chemical compounds involved in normal brain metabolism.  In this trial each patient will be assessed by MRS before
and after a six-week treatment to determine if RG2133 can correct these
chemical imbalances.

   Walter C. Herlihy, Repligen, said, "The use of brain imaging techniques
has the potential to provide a quantitative assessment of the impact of
uridine so that we can better understand its effect in these patients before
designing and initiating larger scale clinical studies."

   Bipolar disorder, also known as manic depression is an illness marked
by extreme changes in mood, thought, energy, and behavior in which a person's mood can alternate between the "poles" of mania (highs) and depression (lows).  Bipolar disorder affects more than two million adults in the United States and is usually diagnosed in late adolescence or early adulthood. When symptoms of mania are left untreated, they can lead to dangerous or even life-threatening situations because mania often involves impaired judgment and reckless behavior.

   According to the American Academy of Child and Adolescent Psychiatry,
up to one-third of the 3.4 million children and adolescents with depression
in the United States may actually be experiencing the early onset of bipolar
disorder.  Unipolar major depression is an extremely common condition characterized by a sustained low mood or loss of interest in one's usual activities, combined with low energy, poor concentration, changes in appetite and sleep, and often, suicidal urges.  There are approximately 20 million adults in the United States that experience major depression and the World Health Organization considers major depression the second leading cause of disability on earth.

   Current drug therapy for bipolar disorder includes the use of lithium
or valproic acid, however side effects are frequent and troublesome, and
patients don't respond fully, leading to frequent recurrences of mania
and depression.  While there are a number of drugs available to treat major
depression, current therapy is limited by side effects including weight
gain, anxiety and sexual dysfunction.  In addition, as in bipolar disorder,
many patients with major depression remain recalcitrant to therapy.


 

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