RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--April 7, 2004--NeoPharm has selected Diosynth Biotechnology to manufacture clinical quantities for their important Phase III trial for malignant glioma, a deadly form of brain cancer. NeoPharm has based their selection on the successful process development and early clinical manufacture of interleukin-13-PE38QQR (IL13-PE38QQR).
IL13-PE38QQR is an experimental tumor-targeting, anti-cancer drug that is currently being investigated as a treatment for first recurrence of glioblastoma multiforme (GBM). GBM is a deadly form of brain cancer for which there are presently few treatment options to prevent the rapid recurrence once the tumor is surgically removed.
"We at Diosynth Biotechnology are pleased to collaborate with NeoPharm to support the development of this very important biological compound," said Jo Lennartz, PhD, General Manager of Diosynth Biotechnology. "Our team is very proud of the contribution delivered to date to the significant scientific advancement that this novel therapy promises for the patients and their families who are impacted by this deadly disease."
Based on the potential of this compound as demonstrated in Phase I / II clinical trials, IL13-PE38QQR received orphan drug designation in Europe and in the U.S., and fast track drug development program status from the U.S. Food and Drug Administration.
"The fast-track status of IL13-PE38QQR exemplifies the commitment of NeoPharm to develop innovative cancer drugs. This is an important milestone on the road to meet the need for a safe and effective treatment for malignant glioma," noted James M. Hussey, President and CEO of NeoPharm, Inc. "We are pleased to be partnering with Diosynth Biotechnology. We have been very impressed by the speed and efficiency with which this highly experienced team has overcome significant challenges to help make this all possible."
As one of the largest and most comprehensive international Phase III trials conducted to date in GBM, the PRECISE study, which stands for Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, will seek to enroll 300 patients in multiple centers across North America, Europe and Israel. It is designed to compare overall survival, drug safety and quality of life for patients receiving either IL13-PE38QQR or Gliadel(R) Wafer, developed by Guilford Pharmaceuticals Inc., of Baltimore, Maryland, following surgical tumor resection (removal). For additional details regarding the PRECISE Trial design, enrollment criteria and participating centers, please visit http://www.clinicaltrials.gov (keyword: IL13-PE38QQR)
Diosynth Biotechnology, a unit of Akzo Nobel, is a market-driven and technology-based manufacturer of complex active pharmaceutical ingredients. The company's biotechnology operations feature the highest quality standards for robust and economically viable process development and cGMP manufacturing services for recombinant proteins, peptides and monoclonal antibodies. Diosynth Biotechnology operates FDA- and EMEA-inspected cGMP production facilities in Research Triangle Park, North Carolina, U.S. and in Oss, the Netherlands serving pharmaceutical and biopharmaceutical customers globally.
Visit us at http://www.DiosynthBiotechnology.com.
Diosynth Biotechnology, Research Triangle Park Magnus Persmark, PhD, 919-337-4400 Toll Free: 866-762-6259 Fax: 919-337-0899 e-mail: firstname.lastname@example.org