Cell Therapeutics Inc. plans to cut operating expenses by 35 percent by focusing its resources on increasing U.S. sales of its non-Hodgkin's lymphoma (NHL) drug Zevalin (ibritumomab tiuxetan).
The Seattle-based firm said it plans to reduce its development work force and will defer or curtail some Phase III trials for its cancer agents Xyotax (paclitaxel poliglumex) and pixantrone (BBR 2778).
The move will reduce CTI's projected net cash operating expenses to a forecasted $77 million in 2008.
As of Sept. 30, the firm had $38.3 million in cash, equivalents and securities.
Shares of CTI (NASDAQ:CTIC) rose 15.3 percent Thursday, or 22 cents, to close at $1.66.
CTI acquired Zevalin, the first radioimmunotherapy approved for marketing in the U.S. for NHL, from Cambridge, Mass.-based Biogen Idec last year for $10 million in cash.
The deal, which closed Dec. 27, included an additional $20 million in milestones and royalties based on net sales for Biogen. (See BioWorld Today, Aug. 17, 2007.)
Zevalin is sold outside the U.S. by Berlin-based Bayer Schering Pharma under an agreement with Biogen.
Biogen reported $17.76 million in total Zevalin revenues for 2006 and $14.2 million for the nine months ending Sept. 30.
The drug, approved by the FDA in 2002, is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL.
CTI plans to seek an additional approval of Zevalin as a first-line consolidation therapy for patients who do not achieve complete remission on standard chemotherapy.
Results reported last week of a Phase II study of Zevalin as consolidation therapy following treatment with a regimen of fludarabine and mitoxantrone in previously untreated patients with nonfollicular indolent NHL demonstrated a 100 percent complete remission at end of treatment with an estimated 89 percent of patients remaining in remission at three years.
Although the company is cutting 31 jobs from its development areas, it plans to add 13 new positions to its Zevalin sales and marketing departments, CTI spokesman Dan Eramian told BioWorld Today.
After the addition of the 13 new employees, CTI's total work force will stand at 133 employees, he noted.
Although the firm is curbing, or "slowing down," the Phase III trials for Xyotax and pixantrone, Eramian said, CTI fully intends to continue its development programs for the drugs this year.
He noted that the company plans to submit a marketing authorization application to European regulators in March for Xyotax as a single agent for first-line treatment of non-small-cell lung cancer (NSCLC) in patients with poor performance status.
Eramian was unable to give a timeline for when CTI will submit a new drug application to the FDA for Xyotax, an investigational biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer.
The drug missed its primary endpoint of significant improvement in overall survival in a Phase III clinical trial. The trial, known as STELLAR 4, compared Xyotax with gemcitabine or vinorelbine in patients with NSCLC with poor performance status.
However, CTI said it received a positive opinion from the Scientific Advice Working Party of the European Medicines Agency that a switch from the superiority endpoint to a noninferiority endpoint was feasible if adequate justification was provided in the marketing application.
Eramian said the company will have data in late summer from a pivotal Phase III trial of pixantrone, a compound being investigated as a treatment for various hematological malignancies, solid tumos and immunological disorders.
CTI also is developing brostallicin, a synthetic second-generation DNA minor groove binder that has shown cancer-killing activity in experimental tumor models.
The compound initially was developed by Italy-based Nerviano Medical Sciences.
More than 200 patients have been treated with brostallicin in single-agent and combination studies, CTI said. Brostallicin currently is in a first-line Phase II study conducted by the European Organization for Research and Treatment of Cancer.
The firm also is developing CT-2106, a polyglutamate-acamptothecin molecule that is in early stage testing as a treatment for patients with colorectal or ovarian cancer.