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Amira Initiates Phase I Clinical Trial of Novel DP2 Antagonist
Date:4/20/2009

Trial Will Evaluate Safety, Proof of Mechanism of a Potential Oral Antagonist for the Treatment of Asthma and COPD

SAN DIEGO, April 20 /PRNewswire/ -- Amira Pharmaceuticals, Inc., announced today the initiation of a Phase I clinical study of AM211, its internally discovered oral drug candidate for the treatment and control of inflammatory and allergic diseases linked to the arachidonic acid pathway.

AM211 is an oral, selective antagonist of the receptor DP2, which recent studies have shown to be a potential target for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis. The Phase I study is designed to obtain safety and proof of mechanism data for AM211.

"There remains a great deal of unmet medical need in asthma and COPD, and we look forward to exploring AM211's potential as a new treatment option," said Isabelle DeArmond, M.D., Vice President Clinical Development. "We may also explore AM211 in other inflammatory diseases based on the safety and proof of mechanism data from our Phase I studies."

DP2 is also known as CRTH2 or chemoattractant receptor-homologous molecule expressed on Th2 lymphocytes. DP2 is a high affinity receptor for prostaglandin D2 and, in humans, is implicated in Th2-dependent allergic inflammation.

"The start of the AM211 clinical studies marks another impressive milestone in our company's short existence. Our small but effective team has been able to bring three distinct molecules into the clinic in less than four years," said Bob Baltera, Amira's Chief Executive Officer. "We look forward to continuing this pace as we advance our next program for idiopathic pulmonary fibrosis toward the clinic."

About Amira

Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of compounds to treat inflammatory disease linked to the phospholipid pathways. Amira has a partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and cardiovascular disease. Amira combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient development of novel compounds and effective pre-clinical and clinical program decisions. Its scientific founders have successfully worked together for more than a decade and were pivotal in the discovery of a number of inflammatory drugs, including Singulair(R). The drug hunters at Amira are now actively leveraging their history of success to create high-value compounds for the future. For more information, visit www.amirapharm.com.


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SOURCE Amira Pharmaceuticals, Inc.
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