TOKYO, July 2, 2012 /CNW/ - Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565), the biopharmaceutical company, today announces
that its wholly owned Japanese subsidiary, Sosei Co., Ltd., has
successfully completed a Japanese Phase I trial for SO-1105 for the
treatment of oropharyngeal candidiasis. SO-1105 was originally
developed by a French pharmaceutical company, BioAlliance Pharma, which
received its first marketing authorization for SO-1105 in France in
October 2006. SO-1105 has since been registered in 26 European
countries, in South Korea, and in the United States, under the trade
The clinical study was conducted in a single study centre in Japan, and
was designed to evaluate the pharmacokinetics and safety of SO-1105 in
healthy Japanese adults.
SO-1105, a once daily muco-adhesive buccal tablet containing 50 mg of
miconazole administered to the buccal mucosa in 12 healthy volunteers
provided a 24-hours sustained high concentration in saliva and on the
infection site (upper surface of the tongue). In addition, low plasma
concentration indicates that no serious systemic adverse events can be
expected. Results from the Phase I study also showed that SO-1105 had a
good overall safety profile, and that usability and compliance were
SO-1105 has the potential to become the first long-acting,
sustained-release treatment in tablet form for oropharyngeal
candidiasis in Japan that could enhance patients' compliance and
quality of life.
Shinichi Tamura, CEO of Sosei Group Corporation, commented: "This is an
important step forward in development of SO-1105. We will continue our
efforts to bring this widely used drug to the Japanese market as
quickly as possible."
Notes for Editors:
About Oropharyngeal Candidiasis
Fungal infections of the oral mucosa are most frequently caused by
Candida species, with C. albicans being the most common species associated with such infections.
Oropharyngeal candidiasis is commonly found in immuno-compromised
patients, including HIV and cancer patients, and in other chronic
disease states such as diabetes. For instance, oropharyngeal
candidiasis is the most frequently occurring infection in head and neck
cancer patients undergoing radiation therapy. The clinical presentation
of oropharyngeal candidiasis is variable with symptoms including
soreness, burning, and/or altered taste. The signs of clinical
candidiasis usually include white pseudomembraneous plaques and patches
(thrush), erythematous lesions or occasionally angular cheilitis. Left
untreated, the condition may progress to involve the esophagus or to
more serious systemic complications.
Sosei is an international biopharmaceutical company anchored in Japan
with a global reach. It practises a reduced risk business model by
acquiring compounds from, and bringing compounds into, Japan through
exploitation of its unique position within global markets.
For further information about Sosei, please visit http://www.sosei.com.
About BioAlliance Pharma
Dedicated to cancer and supportive care - cancer related pathologies,
chemotherapy and radiotherapy-induced complications and opportunistic
infections in immunocompromised patients - BioAlliance conceives and
develops innovative products, especially in the hospital setting and
for orphan or rare diseases.
For more information, visit the BioAlliance Pharma web site at http://www.bioalliancepharma.com.
SOURCE Sosei Group Corporation
For further information:
Sosei Group Corporation, Tokyo Office, Milica STOJKOVIC, Investor Relations, +81(0)3-5210-3399, firstname.lastname@example.org; London Office, Kathryn LYDON, PA to CEO & Corporate Communication, +44(0)20-7691-0983, email@example.com