It is anticipated that HYAL-AV2201's approved Phase III trial
application will form the basis for commencement of additional clinical trials to further evaluate its ability to treat chronic intractable pain, including cancer pain.
The pivotal Phase III trial
, the final trial required before Litx can be submitted for marketing approval, is designed to demonstrate the Litx system's safety and efficacy.
When administered in combination with chemotherapy and after tumor resection, osteosarcoma patients in the phase III trial
, patients receiving Junovan had a significant improvement in Disease Free Survival (DFS) (p<0.
The agreement which involves both process development and manufacturing of the biopharmaceutical drug substance for this clinical phase III trial
, means that we will utilize our extensive expertise and broad experience in protein pharmaceuticals to the full extent," says Hans EurstrEm, SVP Biovitrum Biopharmaceuticals and Marketing & Sales.
The Children's Oncology Group performed the phase III trial
in which 678 patients with newly diagnosed non-metastatic resectable high grade osteosarcoma were treated with Mepact in combination with chemotherapy following surgery.
Paul Meyers, Vice Chair of Pediatrics at Memorial Sloan-Kettering Cancer Center and principal investigator for the Phase III trial
, said, "Osteosarcoma is a childhood cancer for which the outcome, despite advances in surgical and chemotherapeutic approaches, can be very poor in a substantial proportion of patients.
PROCHYMAL is being evaluated in a Phase III trial
for the treatment of Graft vs.
We are making plans to initiate a Phase III trial
in adults in the first half of calendar 2007, and to conduct a small pharmacokinetic study in children to enable us to choose doses for a Phase II / III pediatric study to start later in 2007.
Cobalis completed a Phase III trial
in 2005 that demonstrated that patients who had taken PreHistin showed a reduction of allergy symptoms.
After having successfully completed Phase II clinical trials, Altus had previously planned to initiate Phase III trials
for both programs in the second half of this year.
The results of this trial confirm the results from the first Phase III trial
of SANCTURA XR which were announced on June 15, 2006.