O-15 has not been suspended. Part of the recent rise may be due to progress in batch production. Xoma may update progress or the lack thereof on May 1.
"To avoid further delays, we established a source of manufacturing in collaboration with XOMA (U.S.) LLC
in January 2001."
"Although the manufacturing process at XOMA remains under
development, we expect materials from XOMA for clinical studies after mid-2002."
"To date, ONYX-015 has produced positive Phase II clinical data in head and neck cancer. However, since we had not established a large-scale
manufacturing process and our original partner for this program had been acquired subsequent to establishing our collaboration, the progress in the
development of ONYX-015 has been delayed. To avoid further delays, we established a source of manufacturing in collaboration with XOMA (U.S.) LLC
in January 2001. In addition, we reacquired rights from our collaboration partner to advance the product development in head and neck cancer and to
further develop indications where local or regional administration of ONYX-015 would be feasible. Since Onyx reacquired the rights, we have held
discussions with the FDA in order to seek guidance on a plan of action to further advance the program. As a result of these developments, we have
determined that there are several milestones that Onyx must achieve for this product to advance towards registration. First, additional batches of
product must be made consistently using the large-scale manufacturing process at XOMA. Although the manufacturing process at XOMA remains under
development, we expect materials from XOMA for clinical studies after mid-2002. Additionally, we must reach agreement with the FDA on what
clinical trials and endpoints could lead to marketing approval in the U.S. Until these milestones are met, we will not accelerate the ongoing Phase III
trial or launch additional pivotal trials.
The delay in the trials for ONYX-015 will reduce our planned expenditures on this program in 2002. We will increase our co-funding of
BAY43-9006 in 2002 and, as a result, our overall financial plan for the year and prior financial guidance provided to investors will not change." |
