Milestone represents second drug candidate discovered and optimized with a
computer generated target protein model to enter human clinical trials.
WOBURN, Mass., and RAMAT GAN, ISRAEL, Dec. 20 /PRNewswire/ -- Predix
Pharmaceuticals, a drug discovery and development company, today announced the
initiation of Phase 1 clinical trials of PRX-03140 -- it's second new chemical
entity to enter clinical trials in 2004. PRX-03140 is the Company's second
drug candidate discovered utilizing computer generated GPCR models and
optimized with integrated computational-medicinal chemistry. The compound is a
highly selective, proprietary serotonin 4 (5-HT4) receptor agonist intended to
treat Alzheimer's Disease and other disorders of memory and cognition.
Stimulation of 5-HT4 receptors in the brain has been shown to increase the
release of acetylcholine as well as to have potential neuroprotective
properties.
PRX-03140 has shown activity in several animal models of cognitive
impairment, and increases the release of acetylcholine, soluble APP, and brain
derived neurotrophic factor (BDNF) in the brain of animals. In other studies,
soluble APP has been shown to have plaque-inhibiting activities by reducing
Abeta1-40/42, and BDNF has been shown to improve neuronal survival in disease
models. While stimulating acetylcholine release could provide symptomatic
benefit, the enhanced production of soluble APP and BDNF could have disease
modifying effects.
"We believe PRX-03140 has great potential to become a novel treatment for
disorders affecting memory and cognition," said Stephen Donahue, MD, Vice
President of Clinical and Regulatory Affairs. "The dual mechanism of action --
increasing the release of acetylcholine while stimulating the production of
neuroprotective proteins -- is particularly desirable for treating such
devastating conditions as Alzheimer's disease."
The primary objectives of this single dose-escalation study are to
evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
the compound. The first study may include over 40 healthy volunteers. A
multiple dose study in healthy volunteers, elderly persons, and persons with
mild cognitive impairment could begin in the first half of 2005.
"PRX-03140 represents the second new chemical entity which we have
discovered and brought to the clinic in less than two years, further
validating the power of our drug discovery and optimization engine," said Oren
Becker, PhD, co-founder and Chief Scientific Officer at Predix.
About Predix
Predix Pharmaceuticals is a clinical stage discovery and development
company utilizing proprietary computer-based methods to improve the efficiency
of drug discovery and optimization. Leveraging its proprietary technology,
Predix has created a diverse clinical and pre-clinical stage drug development
pipeline focused in the GPCR and ion channel areas.
The Company's lead product, a 5-HT1A agonist for anxiety and depression,
is expected to enter Phase IIa clinical trials in early 2005. Predix also
anticipates bringing its novel 5-HT2B antagonist for pulmonary hypertension
and pulmonary fibrosis into the clinic in the first half of 2005. The
company is also conducting work on other GPCRs and ion channel drug
candidates.
Predix was incorporated in December, 2000, with its headquarters,
medicinal chemistry, and drug development in Woburn, Massachusetts, and its
computational division in Ramat Gan, Israel.
For More Information:
Christine Hayden
(781) 376-0821 Ext. 1010
http://www.predixpharm.com
SOURCE Predix Pharmaceuticals
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Related links:
http://www.predixpharm.com
CONTACT:
Christine Hayden of Predix, +1-781-376-0821
Ext. 1010
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