Intercell to stop further development of Travelers' Diarrhea Vaccine Patch. Travelers' Diarrhea vaccine candidate failed to meet efficacy endpoints to protect against enterotoxigenic E. The pivotal studies confirm that the vaccine candidate induces reproducible levels of protective antibodies against the LT toxin resulting in a meaningful reduction of LT specific ETEC episodes, following transcutaneous immunization. The projected year end loss for 2. EUR 4. 0m since milestone payments in connection with the Travelers' Diarrhea program are not expected to be received, and the Company expects to impair all or a substantial part of its respective intangible assets. Intercell has taken the decision not to pursue further clinical development of its Travelers' Diarrhea vaccine candidate Intercell will reduce R& D expenses by approximately 4. Management is focusing the Company's R& D strategy and resources on the other projects in its well- balanced clinical stage portfolio, especially the successful and highly attractive nosocomial programs including the investigational vaccines against Pseudomonas and C. The decision was made following the receipt of results of its randomized and placebo- controlled Phase III study (ELT3. Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT2. Europe to India. Both trials were successfully conducted according to study design, met statistical targets of enrollment, participation follow- up, subject and site compliance, and produced a firm preliminary conclusion. The vaccine was generally well tolerated and the safety profile was consistent with that observed in earlier studies. Intercell AG - Quarterly Report Q3. Vaccine-related serious side-effects which.Intercell has killed development of its Travellers’ Diarrhoea Vaccine Patch after the product failed in clinical trials which will lead to job cuts and a dramatic. At Intercell, we have advanced two major platforms of TCI: 1) a needle-free vaccine delivery patch (VDP) and 2) a vaccine enhancement patch (VEP). In an earlier randomized double blind placebo- controlled Phase II field trial (ELT2. TD vaccine candidate showed excellent immunogenicity and reduced the risk of clinically significant diarrheal episodes in U. S. The Phase III trial was intended to confirm the efficacy of the investigational TD Vaccine Patch for prevention of moderate to severe diarrhea in a similar field setting. The trials' primary endpoints, reduction of incidence of all types of enterotoxigenic E. Thus, in the ELT3. ETEC and no apparent effect on the frequency of all- cause moderate to severe diarrhea was observed. However, a statistically significant reduction of duration of all- cause diarrheal episodes and total number of unformed stools was observed, confirming observations from a previous Phase II study. In study ELT3. 01, the vaccine protected most against LT positive ETEC (up to 6. However, the study was not powered to demonstrate a statistically significant efficacy against individual ETEC types. Furthermore the incidence of LT positive ETEC in both trials was lower than expected, compared to previous trials and published data. The current trials have confirmed the previous Phase II observation of a consistent induction of protective levels of antibodies against the LT- toxin following transcutaneous immunization and using the Company's proprietary delivery technology. This clearly supports and validates patch- based vaccination as a suitable route of immunization for future potential product candidates. Intercell is carrying out further analysis of the trial results. However, subject to this analysis and further consultation with its partner, the Company remains committed to expanding the development of the use of patch technology for existing or novel vaccines as well as the development of the investigational Vaccine Enhancement Patch (VEP) system for vaccination against Avian H5. N1 Influenza. Following the successful progression of the S. Hospital- acquired infections represent a major health need and Intercell is well positioned with its portfolio to help address this medical need. Intangible assets pertaining to the TD vaccine program and other patch programs represented a book value of EUR 1. September 3. 0, 2. Intercell expects to impair all or a substantial part of these assets following an impairment analysis triggered by the study results. Such impairment will have a substantial effect on the loss for the full year 2. In addition, Intercell does not expect to receive the previously expected milestone payments in connection with the TD program in 2. Intercell has decided to substantially reduce Research and Development expenses by approximately 4. The measures are expected to be fully effective by mid 2. Our Japanese Encephalitis vaccine is on the market, and we have a world leading and highly attractive nosocomial vaccine franchise in advanced development and a series of promising vaccine and antibody pre- clinical candidates. The cookies contain no personally identifiable information and have no effect once you leave the Medscape site.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
December 2016
Categories |