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Scandinavian Biopharma and PATH sign collaborative development agreement after successful Phase I study of a novel vaccine candidate against diarrheal disease.

Pressmeddelanden   •   2013-12-23 09:28 CET

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. Enterotoxigenic Escherichia coli (ETEC) bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries, leading to over 400 million diarrheal episodes and approximately 300,000 deaths each year. Today there is no ETEC vaccine available to address these unmet needs.

The international global health nonprofit organization PATH and Scandinavian Biopharma have agreed to continue their collaboration to develop a novel vaccine candidate against diarrhea caused by ETEC. Impressive results obtained in a recently conducted clinical Phase I study triggered this decision. PATH supports the project by providing expertise, know-how, and financial resources.

The clinical Phase I study showed very encouraging results. All primary endpoints were exceeded. The vaccine candidate was safe and well tolerated by the study participants. There was a high frequency of response, as 83 percent of the subjects responded to all five of the primary vaccine components; this result exceeds the primary immunological endpoint for the study (at least 50 percent of the subjects responding to at least four of the primary vaccine antigens).

Together, the partners will continue the development of this vaccine candidate in the effort to prevent and control ETEC-related illness and mortality among infants and young children living in ETEC-endemic areas, as well as to prevent ETEC-associated travelers’ diarrhea occurring among international travelers.

The development of this new ETEC vaccine candidate is a collaborative effort among Scandinavian Biopharma, the University of Gothenburg, and PATH.

For more information, please contact:
Björn Sjöstrand, CEO: +46 727-125 120, bjorn.sjostrand@scandinavianbiopharma.se

Scandinavian Biopharma:
Scandinavian Biopharma is a Swedish research-based biotech company engaged in marketing and sales of vaccines, rapid infectious disease tests, antidotes, and immunoglobulins to the Nordic market. Research and development is mainly focused on development of a new oral ETEC vaccine. Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries, and ETEC bacteria are the primary cause of this disease. About 80 million people travel from industrialized countries to high-risk areas in the developing world. Of these, 30 to 50 percent may experience at least one travelers’ diarrhea episode during their journey. ETEC is also a major cause of diarrheal disease among children living in endemic countries.

www.scandinavianbiopharma.com

 

The international global health nonprofit organization PATH and Scandinavian Biopharma have agreed to continue their collaboration to develop a novel vaccine candidate against diarrhea caused by ETEC. Impressive results obtained in a recently conducted clinical Phase I study triggered this decision. PATH supports the project by providing expertise, know-how, and financial resources.

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Scandinavian Biopharma rapporterar framgångsrika resultat i placebo-kontrollerad Fas I studie av ett drickbart diarrévaccin för resenärer och barn i utvecklingsländer

Pressmeddelanden   •   2013-05-21 08:00 CEST

Turistdiarré är den vanligaste infektionssjukdomen bland resenärer till tropiska länder och orsakas oftast av toxinbildande E. coli bakterier (ETEC). ETEC orsakar även diarré bland barn i utvecklingsländer. Ett nytt drickbart ETEC vaccin har utvecklats i Sverige och en stor Fas I studie av vaccinet har nu framgångsrikt genomförts. Alla fördefinierade mål för studien har uppnåtts och överträffats.

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Scandinavian Biopharma announces successful results in placebo-controlled Phase I study of an oral, inactivated vaccine against diarrhea for travelers and children in developing countries

Pressmeddelanden   •   2013-05-21 08:00 CEST

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. ETEC bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries. A clinical Phase I study of a novel vaccine against diarrhea caused by ETEC has been successfully completed. All primary endpoints were achieved.

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Preclinical studies of the new oral Traveler’s diarrhea vaccine shows that it is safe and immunogenic

Nyheter   •   2013-04-08 16:25 CEST

Results from preclinical evaluation of the new multivalent, oral Traveler’s diarrhea vaccine was recently published.  The vaccine, consisting of four inactivated E. coli strains and the ETEC-based B subunit protein LCTBA, was studied for immunogenicity and safety in mice. The optional co-administration of the vaccine with a nontoxic oral adjuvant (dmLT) was also studied. The vaccine was well tolerated and induced a strong intestinal immune response to all vaccine components. The mucosal response was further enhanced when the vaccine was co-administered with the adjuvant.


Based on these results, and results from an earlier completed clinical study in humans with the prototype vaccine (published in Vaccine 2013;31:1163-1170), a clinical phase I study in Swedish adult volunteers is now ongoing to assess the reactogenicity and immunogenicity after two oral immunizations with the vaccine alone and with two different doses of the dmLT adjuvant (study # OEV-121).


The results from the animal studies are published in the peer-reviewed scientific journal Vaccine by Holmgren, J., et al. Development and preclinical evaluation of safety and immunogenicity of an oral ETEC vaccine containing inactivated E. coli bacteria overexpressing colonization factors CFA/I, CS3, CS5 and CS6 combined with a hybrid LT/CT B subunit antigen, administered alone and together with dmLT adjuvant. Vaccine. 2013, http://dx.doi.org/10.1016/j.vaccine.2013.03.027

 

 

Results from preclinical evaluation of the new multivalent, oral Traveler’s diarrhea vaccine was recently published.The vaccine was studied for immunogenicity and safety in mice and was well tolerated and induced a strong intestinal immune response to all vaccine components.

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Scandinavian Biopharma through its subsidiary ETVAX continues clinical development

Pressmeddelanden   •   2013-02-07 16:28 CET

A clinical phase-I, randomized, placebo controlled, double-blinded study of the final composition vaccine, comprising 120 healthy volunteers is presently ongoing. All volunteers have been fully immunized and immunological analyses are ongoing. The study is designed to measure safety and immunogenicity of the vaccine when given either alone or in combination with the immune-enhancing adjuvant dmLT.

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Poliovaccinering

Nyheter   •   2012-10-10 16:00 CEST

Polio, eller barnförlamning som sjukdomen också kallats, var under den första halvan av förra seklet en mycket vanlig sjukdom i Sverige. Sjukdomen håller på att utrotas med hjälp av vaccin, men förekommer fortfarande i en del länder i Afrika och Asien. Poliovaccin ingår i grundskyddet som alla barn får på barnavårdscentralen och i skolan, men man kan i vuxen ålder behöva tilläggsvaccinera sig.

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Nu finns det ett diagnostiskt snabbtest- PerioPruvTM som snabbt och säkert kan påvisa om man löper risk för tandlossning. Scandinavian Biopharma kommer att presentera det nya hjälpmedlet på flera möten under hösten

Nyheter   •   2012-10-05 16:38 CEST

Upp till 40 % av alla vuxna svenskar lider av kronisk parodontit som i värsta fall kan leda till tandlossning. Tack vare PerioPruvTM kan dessa riskpatienter lättare identifieras. PerioPruvTM är ett mycket bra komplement till traditionell visuell diagnostik.

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Scandinavian Biopharma rapporterar positivt resultat från klinisk fas 1 studie av vaccin mot turistdiarré.

Pressmeddelanden   •   2012-08-24 08:00 CEST

Bolaget rapporterar positivt resultat från klinisk fas 1 studie av vaccin mot turistdiarré. Studien visar att vaccinet är säkert och stimulerar produktion av antikroppar. Resultaten är mycket uppmuntrande. En ny fas I studie med det kompletta vaccinet har påbörjats där säkerhet och förmåga att stimulera ett skyddande immunsvar studeras.

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Scandinavian Biopharma announces positive results from its phase I study of a traveler’s diarrhea vaccine

Pressmeddelanden   •   2012-08-24 08:00 CEST

Scandinavian Biopharma announces positive results from its phase I study of a traveler’s diarrhea vaccine.The results are very encouraging. The vaccine was shown to be safe and elicited an intestinal immune response to the vaccine components. A new clinical phase-I study to document the safety and immunogenicity of the final composition vaccine has been initiated.

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  • bjorn.sjostrand@sbdistribution.se
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Om Scandinavian biopharma

Scandinavian Biopharma är ett forskande svenskt biotechföretag som distribuerar, marknadsför och säljer vacciner, immunglobuliner och dentalprodukter på den nordiska marknaden.

Scandinavian Biopharma är ett forskande svenskt biotechföretag som distribuerar, marknadsför och säljer vacciner, immunglobuliner och dentalprodukter på den nordiska marknaden.

Vi utvecklar tillsammans med den amerikanska organisationen PATH Vaccine Solutions och Göteborgs Universitet ett nytt turistdiarrévaccin.

www.scandinavianbiopharma.se

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