Regulatory advice meeting scheduled
A Scientific Advice Meeting has now been scheduled with the Swedish Medical Products Agency (MPA) and will take place September 13th. CombiGene will be assisted by Munich based Granzer Regulatory Consulting & Services in preparing, conducting and following up the meeting.
The main purpose of the meeting is to discuss the non-clinical development program remaining before a first-time-in-man Phase I study can be made with CombiGene’s candidate vector. In addition, a proposed study outline for that study will be discussed, as well as the data and justifications behind CombGene’s choice of candidate vector.
For further information:
CombiGene AB (publ)
Bengt Westrin, CEO
Tel: +46 70 265 48 62
email: bengt.westrin@combigene.com
About Granzer Regulatory Consulting & Services
Granzer Regulatory Consulting & Services provides strategic and hands on support in all aspects of drug development and registration on a global basis. Granzer are experts in CMC, preclinical, clinical development, and medical writing. Granzer has a track record of more than 200 successfully completed centralized, decentralized MAA, NDA, and BLA applications. Granzer’s team of 25 professionals is supported by more than 20 part time specialists to perform all tasks relevant and necessary for the successful global development of new medicinal products in major as well as orphan indications. Among other achievements, Granzer provided advice and support during the development of the first approved gene therapy product, Glybera. www.granzer.biz .
About CombiGene AB
By combining modern neuroscience with recent advances in gene delivery, CombiGene has developed a method shown to suppress epileptic seizures in preclinical studies. Current focus is on continuing to develop this method into an effective and safe therapy for epilepsy patients, but the method may also have development potential as a means of treating other neurological disorders. Founded on the basis of scientific discoveries made at Lund University and the University of Copenhagen, CombiGene has offices at Medicon Village in Lund, Sweden. The company is public and listed on the Swedish marketplace AktieTorget. www.combigene.com .
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