Intercell starts an additional efficacy trial for its patch-based investigational Travelers’ Diarrhea Vaccine System in Asia
- Category: Vaccines
- Published on Monday, 04 January 2010 02:00
- Hits: 1381
* Phase II pilot efficacy trial - placebo controlled field study to evaluate efficacy and enterotoxigenic E. coli (ETEC) incidence of vaccinated European travelers to India
* Study designed to complement ongoing Phase III pivotal efficacy trial of European travelers to Latin America - data expected to further support licensure for prevention of enterotoxigenic E. coli (ETEC) disease in travelers to multiple risk regions
* Results expected for end 2010
Vienna, Austria & Gaithersburg MD, USA | January 4, 2010 | Intercell AG (VSE:ICLL) announced today the start of a Phase II study in India as part of its clinical development program for the investigational Travelers' Diarrhea (TD) Vaccine system. This placebo controlled field study with vaccinated travelers from the EU to India will test the efficacy of the Intercell TD vaccine. The primary objective of this clinical trial is prevention of all moderate/severe diarrheal cases in which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enroll approximately 800 travelers from the UK and Germany.
"The start of our next important TD trial underlines our dynamic route to licensure and earliest possible commercialization with our marketing partner GSK. Positive results from this study can greatly support our expected product target profile" stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA.
About the Travelers’ Diarrhea Vaccine System
The TD vaccine system is a combination of a patch containing the dry‐formulated LT (heatlabile toxin from E. coli, the vaccine antigen) with a skin preparation system (SPS). The skin preparation system (SPS) disrupts the stratum corneum of the skin and prepares the skin for the antigen delivery. The antigen is dissolved from the patch by transepidermal water loss and diffuses into the skin. Activated Langerhans cells take the vaccine antigen to the draining lymph nodes where the immune response is initiated. Currently, this product candidate is undergoing pivotal Phase III testing in about 1,800 European travelers to Latin America. First results are expected end 2010 / early 2011.
About Travelers’ Diarrhea
Diarrhea caused by enterotoxigenic E. coli (ETEC) is a disease associated with significant morbidity in travelers to areas of the world where fecal contamination of food and water is common. Travelersʹ diarrhea is generally a 4‐5 day illness with frequent loose stools, usually associated with nausea, vomiting, abdominal cramps, prostration, and dehydration. ETEC is also implicated in new onsets of post‐infectious irritable bowel syndrome (IBS), which affects 10 to 20% of travelers who develop Travelersʹ Diarrhea.
About Intercell AG
Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercellʹs vaccine to prevent Japanese Encephalitis is the Companyʹs first product on the market.
The Companyʹs technology platforms include an antigen‐discovery system, adjuvants and a novel patch‐based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., Sanofi Pasteur, and Wyeth. The Companyʹs pipeline of investigational products includes a Travelersʹ Diarrhea Vaccine Patch (Phase III), a Pseudomonas vaccine candidate (Phase II), a Vaccine Enhancement Patch to prevent Pandemic Influenza in combination with an injected vaccine (Phase II), a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, three other products focused on infectious diseases are in pre‐clinical development.
SOURCE: Intercell AG