MONTREAL, March 18 /CNW Telbec/ - 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.
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
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
- 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.
For further information:
For further information: Donald Olds, MSc, MBA, Chief Operating Officer
& CFO, Aegera Therapeutics Inc., (514) 288-5532 * 295, email@example.com