Scientists report today in the current issue of Annals of Neurology that
mice treated with a combination of Creatine and Minocycline show a greater
increase in survival than either drug alone. Robert Friedlander, a
professor of neurosurgery at Brigham and Women's Hospital and Harvard
Medical School in Boston and his group treated mice presymptomatically
with either Minocycline or creatine alone and compared them to mice
treated with Creatine and Minocycline. There was 12% increased in survival
in the group of mice treated with creatine and a 13% increase in survival
in the group treated with Minocycline. In mice treated with the
combination of the two compounds survival was increased by 25%. This is
very encouraging data arguing for the value of combining drugs acting on
different disease mechanisms for ALS. No adverse effects were detected in
the mice treated with both drugs. Currently trials are ongoing for both
Creatine and Minocycline. Although it is likely that many patients are
already taking both Creatine and Minocycline, a controlled clinical trail
combining these two drugs would be valuable to determine whether there is
an increase in efficacy of the two drugs when given together. It should be
noted that many of the compounds tested in the mouse models of ALS
including this study are administered prior to onset of symptoms. This is
not the case in the clinical setting where patients are already showing
symptoms of the disease at the time they take the drugs and may account
for the modest effect of these drugs in the clinic. This further supports
the potential of combining drugs acting on different disease mechanisms to
treat patients with ALS.

Stephen Scelsa, MD, Director of the Neuromuscular Division and ALSA
certified Center, Beth Israel Medical Center and Associate Professor of
Clinical Neurology, Albert Einstein Medical School, New York, New York,
comments, "This is exciting news since many leaders in ALS research
believe that progress will be made in slowing disease progression by
combining less effective therapies with different mechanisms of action. It
will be important first to show, through clinical trials, that each of
these drugs has at least some marginal benefit in patients with ALS,
before trying combination therapy, since only one drug in a combination
may be effective. Fortunately, both Creatine and Minocycline have few
serious side effects. I hope that the findings in clinical trials of these
drugs in humans will mimic the findings in mice. We will only determine
this by carefully planned, placebo-controlled trials."

"This is an important finding from animal research that may have a
potential direct benefit for people with ALS," notes Mary Lyon, RN, MN,
ALSA's Vice President, Patient Services. We can all be very encouraged
that these two therapies had an additive effect in the mice without
significant adverse events or side effects.

The next steps are to encourage and support replication animal studies and
to consider clinical trials with Creatine and Minocycline in people with
ALS. Although both creatine Minocycline and (physician prescription
required) are currently available, ALSA stresses the importance of
consulting with your ALS physician before starting any treatment.

Both Creatine and Minocycline are in clinical trials now as sole
therapies. The results of these studies will be important in determining
if the combination of the two may benefit people with ALS. An important
distinction between the animal study and human trials is that the
combination treatment was begun with the mice before the onset of symptoms
of the disease.

Combination therapy for ALS has long been a goal in the ALS community and
this study is an exciting sign that the hope may be realized soon. The ALS
Association's Drug Company Working Group convenes researchers, clinicians
and pharmaceutical companies to encourage ALS drug development and
establish relationships to facilitate combination therapies in ALS.

The ALS Association (ALSA) is the only national not-for-profit voluntary
health organization dedicated solely to the fight against amyotrophic
lateral sclerosis, ALS (often called Lou Gehrig's disease). The mission of
The ALS Association is to find a cure for and improve living with ALS. The
ALS Association seeks to promote awareness and understanding of ALS and
the work of The ALS Association by providing up-to-date information and
education materials to the ALS community including ALS patients and
families, caregivers, researchers and members in the health care fields.

For more information about Creatine and Minocycline and ALS contact:

Mary Lyon, RN, MN
Vice President Patient Services (mary@alsa-national.org or 818-880-9007).

Lucie Bruijn, PhD
Science Director and Vice President (lucie@alsa-national.org).