ActoBiotics

ActoBiotics (a registered trademark) consist of food-grade bacteria (Lactococcus lactis), genetically engineered to synthesize and secrete therapeutic proteins and peptides in situ. ActoBiotics are delivered to patients via oral administration instead of injection, and specifically target receptors and cells localized in gastrointestinal (GI) tissues. The selective and targeted delivery to GI receptors, may increase efficacy combined with a more favorable side effect profile.[1][2][3]

ActoBiotics are developed by ActoGeniX, a biopharmaceutical company based in Ghent, Belgium. ActoBiotics are formulated as oral capsules.

A scientific article by L. Steidler stated: "ActoBiotics represent a novel class of orally administered and locally acting biopharmaceuticals." [4] ActoBiotics display significant competitive advantages over first and second generation pharma products (conventional chemical drugs and biologicals respectively).[5][6][7]

ActoGeniX’s lead product, AG013, is an ActoBiotic for the treatment of oral mucositis. In May 2009, the U.S. Food and Drug Administration (FDA) approved ActoGeniX’s IND application, allowing the company to initiate a phase 1B clinical trial with AG013 in cancer patients at risk of developing oral mucositis. This clinical study has been recently finalized. AG013 was proven to be safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative oral mucositis.[8][9]

A press release by the University of Leuven stated: "In April 2012, Prof. Chantal Mathieu and her team at the University Hospital of Leuven announced a potential major breakthrough in the treatment of Type 1 diabetes using the drug. The ActoBiotic can stably reinstate normal glucose levels in Type 1 diabetic mice. This strategy was without side effects and can now be further developed for human application."[10] The Journal of Clinical Investigation published the results of the study.[11]

Indications

ActoBiotics focus on areas with unmet need in gastrointestinal, immunological and metabolic diseases:

Production

ActoBiotics are produced by conventional bacterial fermentation, followed by freeze-drying. The lyophilized powder is then formulated into capsules for oral administration.

Administration

ActoBiotics are generally formulated in capsules or an oral rinsing form for oral administration.

References

  1. ↑ Steidler L & Vandenbroucke K. Genetically modified Lactococcus lactis: novel tools for drug delivery. International Journal of Dairy Technology 2006; 59, 140-146
  2. ↑ http://www.jci.org/articles/view/60530
  3. ↑ Steidler L, Hans W, Schotte L, Neirynck S, Obermeier F, Falk W, Fiers W, Remaut E. Treatment of murine colitis by Lactococcus lactis secreting Interleukin-10. Science 2000; 289(5483), 1352-1355
  4. ↑ Steidler L. Live genetically modified bacteria as drug delivery tools: at the doorstep of a new pharmacology? Expert Opinion on Biological Therapy 2004; 4, 439-441
  5. ↑ Steidler L & Vandenbroucke K. Genetically modified Lactococcus lactis: novel tools for drug delivery. International Journal of Dairy Technology 2006; 59, 140-146
  6. ↑ http://www.ncbi.nlm.nih.gov/pubmed/20074282
  7. ↑ Frossard CP, Steidler L, Eigenmann PA. Oral administration of an IL-10-secreting Lactococcus lactis strain prevents food-induced IgE sensitization. Journal of Allergy and Clinical Immunology 2007; 119, 952-959
  8. ↑ http://www.actogenix.com/eng/documents/news/pressreleases/ActoGeniX%20Press%20Release%20ENG%2015%20Sept%202011.pdf
  9. ↑ Commenting on the results of the Phase 1B study, Dr. Stephen T. Sonis, Clinical Professor of Oral Medicine at Harvard University, and a senior surgeon at Brigham and Women's Hospital and the Dana Farber Cancer Institute states: “The results of this Phase 1B trial are important in confirming the safety and tolerability of ActoGeniX' novel platform as a means of delivering biologically active molecules to the oral mucosa of patients at risk of mucositis. And, although subject numbers are small, the observed efficacy trend fully supports further exploration of AG013 as an oral mucositis intervention.”
  10. ↑ http://www.kuleuven.be/english/news/a-permanent-cure-for-type-1-diabetes
  11. ↑ http://www.jci.org/articles/view/60530
  12. ↑ Caluwaerts S, Vandenbroucke K, Steidler L, Neirynck S, Vanhoenacker P, Corveleyn S, Watkins B, Sonis S, Coulie B, Rottiers P. AG013, a mouth rinse formulation of Lactococcuslactis secreting human Trefoil Factor 1, provides a safe and efficacious therapeutic tool for treating oral mucositis. Oral Oncology 2010 Jul;46(7):564-70
  13. ↑ http://www.ncbi.nlm.nih.gov/pubmed/19794409
  14. ↑ http://www.jci.org/articles/view/60530

External links

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