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Aegera initiates Phase 1 clinical trial of AEG33773 - A small molecule in development for diabetic neuropathic pain

MONTREAL, March 18 /PRNewswire/ - Aegera Therapeutics announced today the initiation of a Phase 1, first-in-man, clinical trial for AEG33773, a novel, orally bioavailable small molecule in development for the treatment of painful diabetic neuropathy. The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of AEG33773 using a randomized, double blind, placebo controlled, single ascending dose design in healthy male volunteers.

Aegera completed a comprehensive pre-clinical development program on AEG33773, culminating in regulatory clearance from Health Canada and treatment of a first patient, in less than 12 months.

"We are extremely excited about the potential for AEG33773 to treat painful diabetic neuropathy and to expand to other pain and neuropathy indications, based on our extensive preclinical experience with this family of compounds in multiple models of pain and neuropathy," commented Dr. Jon Durkin, Vice-President Research and Preclinical Development at Aegera.

"This important milestone was achieved in record time, as the Aegera team has successfully filed regulatory applications for two potential blockbuster compounds, AEG33773 and AEG40826, in the last three months while initiating multiple Phase 2 trials for our lead program AEG35156. Aegera now has four unique programs in clinical development and is poised to deliver significant clinical data over the next 12-18 months" added Dr. Michael J. Berendt, Aegera's President and CEO.

About AEG33773

AEG33773 was developed as an orally bioavailable small molecule compound which provides acute pain relief in preclinical models of neuropathic and inflammatory pain. In addition, AEG33773's unique mechanism of action has demonstrated excellent in vivo activity in models of diabetic neuropathy with respect to its ability to not only prevent, but also to reverse established neuropathies.

About Aegera Therapeutics Inc.

Aegera Therapeutics is a clinical stage biotechnology company focused on developing drugs that control apoptosis to address major unmet medical needs. In addition to AEG33773, Aegera has three programs in clinical development for oncology indications:

- AEG35156 targets the key anti-apoptotic protein XIAP, and is currently

in multiple Phase II human clinical trials for the treatment of solid

tumors and leukemia;

- AEG41174 is a novel, non-ATP competitive, small molecule tyrosine

kinase inhibitor targeting therapeutically significant kinases

including JAK2 and Bcr-Abl, and is currently in Phase 1 clinical


- AEG40826 (HGS1029) is a small molecule IAP inhibitor that has shown

promising preclinical activity alone and in combination with other

anti-neoplastic agents across a broad range of cancers. A license and

collaboration agreement was executed in December 2007 whereby Human

Genome Sciences, Inc. (Nasdaq: HGSI) acquired exclusive rights to

develop and commercialize small-molecule IAP inhibitors in oncology.


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