Gluten Busters: Gluten-Free Product Alerts by Celiac.com

Celiac.com 03/16/2016 - ImmunogenX, a biopharmaceutical company focused on the diagnosis and treatment of autoimmune and gastrointestinal diseases, today announced that it has completed the acquisition of the non-cash assets of Alvine Pharmaceuticals. This includes the Latiglutenase (formerly known as ALV003 and renamed IMGX-003), an orally administered mixture of two recombinant gluten-specific proteases that degrades gluten proteins into small physiologically irrelevant fragments. The technology is backed by over 50 issued or pending patents, has been extensively studied in Phase I and Phase 2 clinical trials, and is the only CD treatment that has demonstrated histologic success as well as symptomatic improvements in clinical trials.

Celiac.com Sponsor (A13):
"We are exceptionally fortunate to have had the opportunity to acquire what is arguably the leading therapeutic advance for celiac disease," said Dr. Jack A. Syage, CEO of ImmunogenX. "Alvine has established itself as one of the most professional and accomplished emerging biopharmaceutical companies and has made tremendous progress in advancing its recombinant protease drug product through clinical trials. We are privileged to be entrusted to take this much needed therapy through development and to market to help improve the quality of life of celiac disease patients who suffer from the inevitable intrusions of gluten that occur even under the most diligent of gluten-free diets."

David Southern, Alvine’s CFO and Acting CEO commented, "We are gratified that ALV003, which in randomized clinical trials appeared to be well tolerated and attenuated gluten-induced intestinal mucosal injury in well-controlled celiac patients, will be further developed by a company that is deeply knowledgeable about celiac disease and plans to take it through late-stage clinical trials. ImmungenX has impressed us with their exceptional team, their drive, and most of all their dedication to helping the celiac community."

"I have had the privilege of participating in ALV003 trials and am aware of the tremendous potential benefits it may offer celiac disease sufferers," remarked Dr. Peter H. R. Green, MD, head of the Celiac Center at Columbia University. "As a member of both the Alvine and ImmunogenX scientific advisory boards, I cannot be more happy to see ALV003 transition smoothly into such capable hands."

About ImmunogenX

"ImmunogenX" (a subsidiary of Immunogenics LLC) is a clinical-stage company founded in 2013 and is supported by a team of world-renowned clinicians, scientists and advisors in celiac disease research. In addition to the newly-acquired IMGX-003, ImmunogenX is developing an advanced diagnostic tool. For disease management, ImmunogenX is extending and commercializing a successful clinical study for a metabolic marker compound that can measure the state of recovery of a celiac patient undergoing gluten-free diet treatment. This is a unique capability for which there is no other effective diagnostic. For food safety, ImmunogenX is pioneering advanced mass spectrometry methods to identify new physiologically relevant gluten peptide sequences in wheat, barley, and rye and has developed a multiplexed quantitation method to screen for the full range of gluten proteins in food and consumer products.
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