In the wake of FDA asking for further clinical evaluation of its lead candidate, Cell Therapeutics (CTI) has decided to cut 36 employees. The company will also not increase its commercial personnel as it had previously planned.
Cell Therapeutics believes that these steps along with a reduction in operating expenses will result in savings of approximately $16 million this year. The company projects operating expenses in 2010, excluding equity-based compensation, of approximately $60 million. This represents a 21% reduction from its previously projected estimates. The firm’s target for average net operating burn rate is approximately $4.4 million per month starting in the second quarter.
On April 9, the FDA sent Cell Therapeutics a complete response letter regarding the approval of Pixuvri™ in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). The agency requires additional clinical data that demonstrates the therapy’s safety and effectiveness, since the firm’s last Phase III trial raised some concerns over the its side effect profile.
Those receiving the drug had a low incidence of severe neutropenia complicated by either fever, infections, severe vomiting, or diarrhea. Pixantrone patients also had a higher incidence of leucopenia and numerically more severe cardiac events. Only one cardiac event was considered to be related to the study drug, according the company.
The FDA did, however, give the company the option to make the drug available to patients. Pixuvri is an aza-anthracenedione that has distinct structural and physio-chemical properties that make its antitumor activity unique in this class of agents, according to CTI. Similar to anthracyclines, pixantrone inhibits topo-isomerase II. Unlike anthracyclines, though, rather than intercalation with DNA, Pixuvri alkylates DNA to form stable DNA adducts with particular specificity for CpG rich, hyper-methylated sites.
In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen-free radicals and the formation of toxic drug-metal complexes have also been modified in Pixuvri.