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Greenovation Biotech GmbH. (3/9/15). "Press Release: Greenovation Successfully Completes Preclinical Toxicology Studies of alpha–Galactosidase". Freiburg.
|Organisation||Greenovation Biotech GmbH|
|Product||Moss-aGal (recombinant human alpha-galactosidase)|
|Product 2||preclinical research|
|Person||Frischmuth, Thomas (Panatecs 201205– Managing Director + Greenovation 201105 Managing Director + baseclick)|
Greenovation Biotech GmbH has successfully completed GLP toxicology studies in non-human primates, and has demonstrated that the moss-aGal (Agalsidase) is safe and very well-tolerated in repeated high dose administrations. The plant-based cGMP manufacturing process resulted in a high yield batch of moss-aGal to be used in upcoming clinical trials.
The GLP toxicology studies in non-human primates demonstrate the moss-aGal to be safe and well tolerated at a dose of 5 to 10 fold higher than the expected human therapeutic dose. In summary, the study investigated intravenous administration of moss-aGal via two 40-minute infusions at doses of either 0 or 5 mg/kg to male and female cynomolgus monkeys. As a result, the study concludes that moss-aGal was very well tolerated under the given study conditions and did not reveal any treatment-related findings. Thus, the no-observed-adverse-effect-level (NOAEL) is considered to be the tested dose level of 5 mg/kg.
“The successful cGMP manufacturing of moss-aGal in the moss expression plattform and the successfully concluded toxicology studies are major developmental milestones for Greenovations alpha-Galactosidase program. Currently we are working on our regulatory package for a Phase I/II clinical trial which includes Fabry Disease patients,“ stated Dr. Thomas Frischmuth, CEO of Greenovation. “Achieving a proprietary, commercially viable manufacturing process of alpha-Galactosidase demonstrates the successful development of Greenovation into a biopharmaceutical company.”
About Greenovation Biotech GmbH
Greenovation develops next generation biopharmaceuticals in particular in rare disease indications. Human alpha-Galactosidase is the company’s lead product being developed as enzyme-replacement therapy (ERT) for Fabry Disease. Results of the recently completed pre-clinical program clearly indicate superiority features with respect to pharmacokinetics (delayed clearance), pharmacodynamics and biodistribution. A multi-center clinical Phase I/II study with this candidate will be undertaken in Europe.
Greenovation’s development pipeline further includes glucocerebrosidase (glucerase, for ERT of Gaucher’s disease), complement factor H (to treat atypical HUS), antibody (IgG) programs for enhanced ADCC as well as growth factors (FGF7/KGF, EGF, HGF) for various applications.
Contact and further information
Greenovation Biotech GmbH
Tel. +49 (0)761 470 99 0
Record changed: 2016-06-07
More documents for Greenovation Biotech GmbH
-  Greenovation Biotech GmbH. (5/4/15). "Press Release: Greenovation Filed Phase I Clinical Trial Application for Its moss-aGal Compound Intended for Treatment of Patients Suffering from Fabry Disease". Freiburg....
-  Greenovation Biotech GmbH. (3/31/15). "Press Release: Greenovation and University of Freiburg Cooperate to Fight an Extremely Rare Disease". Freiburg....
-  Greenovation Biotech GmbH. (9/29/14). "Press Release: First GMP-Compliant Batch of a Biologic Drug Substance from a Moss Expression System Produced for Clinical Use". Freiburg....
-  Greenovation Biotech GmbH. (5/6/14). "Press Release: Greenovation Biotech GmbH Strengthens Corporate Management Enhancing Its Business Focus on Biopharmaceuticals". Freiburg....
-  University of Freiburg. (8/21/13). "Press Release: Research with the Moss Bioreactor. University of Freiburg and Greenovation Biotech to Cooperate on Improved Product Yields". Freiburg....
-  BIOPRO Baden-Württemberg GmbH. (8/5/13). "News: Greenovation Biotech GmbH – Production of Therapeutic Proteins in Moss"....
-  Biomeva GmbH. (5/6/13). "Press Release: Greenovation Biotech GmbH and Biomeva GmbH Sign Development, Manufacturing and Supply Agreement for GMP Production of a Protein with a Novel Expression Platform". Freiburg & Heidelberg....
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