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Preclinical data confirms
TRO19622 is effective in a model of diabetic neuropathic pain
Trophos expects to initiate
European based Phase II trial in neuropathic pain by end 2006
Marseille, June 9, 2006 - Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurodegenerative diseases and other neurological disorders, announced today it will initiate a European Phase II clinical trial in diabetic neuropathic pain employing its lead compound TRO19622, by the end of 2006. This follows the successful outcome of preclinical studies. The decision to move forward in this indication comes as Trophos is completing Phase Ib trials that will pave the way for a Phase II/III clinical trial of TRO19622 for the ALS indication in Q1 2007. TRO19622 is representative of novel compounds identified using the proprietary neuronal cell screening platform developed at Trophos. Preclinical studies have demonstrated that these compounds promote the survival of a wide range of neurons in vitro, as well as in several in vivo models of neurodegenerative diseases. The mechanism of action of this "first-in-class" series of molecules predicted they would have potential for the treatment of other chronic neurological disorders, including neuropathic pain. Preclinical data from two independent studies using a widely accepted in vivo model of diabetic neuropathic pain support this hypothesis. Trophos will present preclinical data at NEURODIAB XVI, the 16th annual meeting of the Diabetic Neuropathy Study Group in Ystad, Sweden, September 10-13, 2006 and at the annual meeting of the Society for Neuroscience in Atlanta October 14-18, 2006.
TRO19622 has successfully
completed Phase I clinical trials having been demonstrated to: i) be well
tolerated, ii) have achieved the predicted effective clinical dose via the
oral route and, iii) have an excellent safety profile. Trophos now expects
to move forward with a Phase II clinical study in the diabetic neuropathic
pain indication by the end of 2006. In addition, TRO19622 is currently in
Phase Ib clinical studies that will pave the way for the initiation of a
pivotal Phase II/III clinical trial for the ALS indication in 1Q, 2007. The
trials will be conducted in Europe.
"We are excited that we have
been able to confirm our hypothesis that TRO19622, due to its novel
mechanism of action, will be effective for neuropathic pain," said Dr
Rebecca Pruss, Chief Scientific Officer at Trophos. "The molecule, first
discovered through its neuroprotective properties in our innovative
phenotypic screening platform, has real promise based on the results of
these preclinical studies in diabetic rats. These studies support our
strategy to initiate a proof of concept trial in patients with diabetic
neuropathic pain. Furthermore, the mechanism of action of this class of
molecules is likely to have tremendous potential for the treatment of other
chronic neurological disorders."
About neuropathic pain: Neuropathic pain can be defined as a pain, caused by nerve injury, which is often difficult to treat and does not respond to treatments effective in other types of pain. The global prevalence of neuropathic pain is believed to be at least 2.4 percent, and greater in those over 55 years of age. Diabetic neuropathies are a family of nerve disorders caused by diabetes leading to numbness, weakness and sometimes pain in the hands, arms, feet and legs. About 15 percent of diabetics in the USA (3 million people) are thought to experience diabetic nerve pain. The market for neuropathic pain treatments is estimated at USD 2.5 billion and growing. About ALS:
ALS, more commonly
known as Lou Gehrig's disease in the USA, is a progressive and fatal
neurological disease characterized by the loss of motor neurons in the brain
and the spinal cord leading to progressive paralysis of the muscles. It is
estimated to affect approximately 100,000 people worldwide. There is no cure
for ALS. The only drug approved for ALS is riluzole, which has been
demonstrated to prolong the life of ALS patients by a few months. For more
information about ALS, see
www.alsa.org.
About Trophos:
www.trophos.com
Trophos is a biopharmaceutical company developing drugs to treat neurodegenerative diseases. These are severely debilitating, often fatal, disorders with few effective drugs and tremendous unmet medical needs. Trophos has pioneered an innovative phenotypic screening platform which has enabled it to develop a proprietary portfolio of products in preclinical and clinical phases of development. In preclinical studies, compounds in the same class as TRO19622 have been shown to prevent the neuronal degeneration that is involved in the progression of these types of neurological disorders. The company is focusing its efforts on four therapeutic domains: neuropathic pain, the motoneuron diseases (ALS & SMA), Huntington's disease and Alzheimer's disease.
Trophos was founded in 1999, is
based in Marseille, France and currently has 35 employees.
For more information please
contact:
Andrew Lloyd & Associates
Andrew Lloyd / Heidi Thompson
Tel: +44 1273 675100
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