Gene Therapy Review: Gene and Cell Therapy Resource
ARK fails to get MAA for Cerepro
- Details
- Category: Editorial Team
- Published on Friday, 18 December 2009 00:00
- Written by Administrator
- Hits: 3093
Today Ark released the negative opinion of EMEA for it's crucial Cerepro- drug.
"The main underlying objection from the regulator which had not been resolved concerns specifically whether or not patients treated with Cerepro® might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro®. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend approval based on the data presented by Ark so far. The CHMP has thus adopted a negative opinion as Ark had not at that point in time provided trial evidence beyond doubt that Cerepro® has demonstrated adequate efficacy."
The negative result was a severe blow for company's future and was immiteadly reflected on stock price, which was on freefall. However, the company plans on appealing against the decision.
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What is Gene Therapy?
Gene Therapy is the transfer of genetic material (gene transfer) to dysfunctional cells to correct a deficiency in the DNA or genome of a patient. Cell Therapy, such as stem cell therapy, can also be used to achieve these goals. These approaches can be applied to genetic disorders as well as diseases acquired over the lifetime of an individual, such as cancer or infection, to confer a specific property to the cell allowing it to combat the disease.