Picoplatin (NX 473) is a next-generation intravenous platinum chemotherapeutic agent specifically designed to improve on the safety and efficacy of existing platinum therapeutics for cancer.
The company also announced plans to cease operations at its facility in Denton, Texas, where STR was being manufactured. Resources will be redirected to the picoplatin development program, including the initiation of a planned phase II trial of picoplatin in small cell lung cancer in mid-2005, as well as a clinical program in colorectal cancer by early 2006 and potentially other indications.
“While we believe STR is an innovative cancer therapeutic, a variety of factors contributed to our decision to discontinue the program and apply our resources to the development of picoplatin,” explained Dr Jerry McMahon, chairman and CEO of NeoRx.
“The FDA indicated that it wanted to renegotiate the special protocol assessment for the current phase III trial. The changes mentioned by the FDA would have extended the endpoints of the trial, increasing the number of patients and the length of follow up, and thus substantially increasing the time and cost to complete the trial.”
“This uncertain regulatory situation combined with the changing treatment landscape have made negotiations with potential STR partners more challenging than anticipated and finding a funding partner unlikely.”
Earlier this week, NeoRx signed a manufacturing and supply agreement with Hyaluron for the production of picoplatin product for clinical trials.
NeoRx currently estimates that it will incur restructuring charges of approximately $2 million during 2005 and 2006, associated with the reduction in workforce and the termination of contracts and other obligations related to the STR program.