SAN CARLOS, Calif. - (Business Wire)
Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the
treatment of autoimmune and gastrointestinal diseases, today announced
that the first study subject was dosed in a Phase 1 clinical trial of
its lead clinical candidate ALV003 which is in development for the
treatment of patients with celiac disease. ALV003 is an orally
administered combination of two proteases engineered to detoxify gluten.
Approximately 36 subjects are planned for enrollment in the Phase 1,
single-blind, placebo controlled, dose-escalation clinical trial to be
conducted in the United States. Both healthy human volunteers and
subjects with celiac disease are expected to be dosed in this trial.
“We are very excited to begin our clinical
program evaluating ALV003 for the treatment of celiac disease,”
said Dr. Abhay Joshi, President and Chief Executive Officer of Alvine.
The October 25, 2007 issue of the New England Journal of Medicine
discusses gluten detoxification as an approach to treating celiac
disease. Authors Peter H.R. Green, M.D. and Christophe Cellier, M.D.,
Ph.D. state in the article: “There is
considerable interest in the development of nondietary therapies that
might either replace or supplement the rigorous gluten-free diet.
Currently, the most attractive alternative involves the use of
recombinant enzymes that digest the toxic gliadin fractions in the
stomach or the upper small intestine.”
About ALV003
ALV003 is an orally administered combination of two proteases engineered
to digest gluten. It targets the glutamine and proline residues that are
common in gluten. ALV003 consists of a glutamine-specific cysteine
protease (EP-B2) and a proline specific prolyl endopeptidase (PEP). The
proposed mechanism of action of ALV003 is to digest gluten into
non-immunotoxic fragments.
About Celiac Disease
Celiac disease is the most common hereditary autoimmune disease with
prevalence as high as 1% in the U.S. and E.U. Celiac disease is
triggered by the ingestion of gluten in genetically susceptible
individuals. Gluten is a protein found naturally in wheat, rye, and
barley, and is one of the most common food additives in the human diet.
Patients with celiac disease mount an immune response to gluten and
gluten fragments, resulting in systemic immune mediated damage in the
gut and other organs. Gluten ingestion can be associated with symptoms
such as nausea, diarrhea, constipation and rash. Complications of celiac
disease can include osteoporosis, anemia, dermatitis, weight loss,
diabetes, central nervous system conditions, other autoimmune diseases
and malignancies. There are currently no approved pharmaceutical
therapies for celiac disease. The only available treatment for
individuals diagnosed with celiac disease is a life-long adherence to a
strict gluten-free diet which is difficult to follow. There is a high
unmet medical need for celiac disease therapies.
About Alvine
Alvine Pharmaceuticals, Inc., is a privately held biopharmaceutical
company dedicated to developing and commercializing therapeutics for
autoimmune/gastrointestinal diseases. Alvine’s
lead product candidate, ALV003, is a combination protease engineered to
digest gluten. It is being developed to treat patients with celiac
disease. For additional information about the company, please visit www.alvinepharma.com.
Alvine Pharmaceuticals, Inc.
Kirk Essenmacher M.D., M.B.A.,
650-596-2434
Vice President of Marketing,
Corporate and
Strategic Development
or
Revati Shreeniwas M.D., 650-596-2433
(Clinical Contact)
Vice President, Clinical Research and Development
