| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers N > Headlines for NeoPharm Inc. > News item |
NeoPharm to continue Precise trial to final efficacy analysis at 215 deaths
By Lisa Kerner
Charlotte, N.C., June 22 - NeoPharm, Inc. said that after analyzing interim efficacy results (160 deaths) from its pivotal phase 3 Precise trial for the treatment of glioblastoma multiforme (GBM) (malignant brain tumor), the Data Monitoring Committee recommended that the trial continue to the final efficacy analysis at 215 deaths.
"We knew that reaching the interim efficacy endpoint was an extremely high statistical hurdle and we look forward to the final study endpoint, which we currently expect to occur in the first quarter of 2007," president and chief executive officer Guillermo A. Herrera said in a company news release.
"We continue to be encouraged by the previously reported prolonged survival times observed in the phase 1/ 2 trials and view these prolonged survival times as providing evidence that the Precise trial milestones will eventually be achieved."
A statistically significant difference in the overall survival curves of the recombinant protein cintredekin besudotox and the chemotherapy-delivering Gliadel wafer will indicate the trial has met its endpoint.
Precise is a randomized, controlled trial to compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving Gliadel Wafer in the treatment of first recurrent GBM following surgical tumor resection.
Cintredekin besudotox has received orphan-drug designation and fast-track designation from the Food and Drug Administration as well as orphan-drug designation in Europe.
NeoPharm, based in Waukegan, Ill., develops and commercializes cancer drugs.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.