Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Schering-Plough has told Migenix that half of the viral load samples from a phase II study of hepatitis therapy celgosivir require retesting.
Subscribe to our email newsletter
Schering-Plough was supplying Pegetron (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as well as other services for the trial as part of an agreement between the two companies.
In addition, the agreement granted Schering limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.
The companies have said that as a result of the retesting, Schering's limited period of exclusivity for data review of the results has not yet commenced.
Migenix has received results for approximately half of the required retests from Schering which leaves approximately 25% of the original viral load samples from the study to be retested.
Based on a preliminary review of these results, Migenix said it appears the overall conclusions will remain consistent with the original study analysis. However, as all retesting has not been completed, Migenix said it was unknown whether the retesting will result in any material changes to previously reported results.
It is estimated that a period of approximately eight weeks will be needed to finish the retesting and complete the new data package of the results, after which Schering's limited period of exclusivity for data review will commence.
“While the retesting represents a delay, we are encouraged by our preliminary analysis of the partial retesting results,” said Jim DeMesa, president & CEO of Migenix.