Nuvelo ends catheter occlusion drug development, initiates lay-offs
Poor results from its Phase 2 trial of a drug to open occluded catheters have prompted Nuvelo to halt the program and reduce its work force.
The SONOMA-3 (Speedy Opening of did not show sufficient improvement in catheter opening at the higher dose and concentration evaluated to meet the desired target product profile, according to the company.
Nuvelo will also end further clinical development of alfimeprase in regards to acute ischemic stroke.
About 40 full time employees and contractors will be let go as a result of the decision to stop the trial. Michael Levy, MD, executive vice president of research and development, also will leavethe company.
In the open-label, single-arm, SONOMA-3 trial, alfimeprase restored catheter function in about 50 percent of patients at 15 minutes, and approximately 60 percent of patients at one hour, according to the San Carlos, Calif.-based company.
While the 15-minute clearance rate represents an improvement over the previous Phase 3 SONOMA-2 trial, which evaluated a lower dose and concentration of alfimeprase than the SONOMA-3 trial, the company said that the clearance rate at one hour fell short of its expectations.
The company anticipates incurring restructuring charges of approximately $3 million in the first quarter of 2008 primarily related to severance payments to departing employees, including approximately $1.2 million of stock-based compensation expense.
As a result of the realignment of personnel and programs, 2008 operating expenses are now expected to be in the range of $47 to $52 million, and net cash used in operating activities to be in the range of $43 to $48 million, according to the company. As of Dec. 31, 2007, Nuvelo had $103.6 million in cash and cash equivalents, short-term investments and restricted cash.
The SONOMA-3 (Speedy Opening of did not show sufficient improvement in catheter opening at the higher dose and concentration evaluated to meet the desired target product profile, according to the company.
Nuvelo will also end further clinical development of alfimeprase in regards to acute ischemic stroke.
About 40 full time employees and contractors will be let go as a result of the decision to stop the trial. Michael Levy, MD, executive vice president of research and development, also will leavethe company.
In the open-label, single-arm, SONOMA-3 trial, alfimeprase restored catheter function in about 50 percent of patients at 15 minutes, and approximately 60 percent of patients at one hour, according to the San Carlos, Calif.-based company.
While the 15-minute clearance rate represents an improvement over the previous Phase 3 SONOMA-2 trial, which evaluated a lower dose and concentration of alfimeprase than the SONOMA-3 trial, the company said that the clearance rate at one hour fell short of its expectations.
The company anticipates incurring restructuring charges of approximately $3 million in the first quarter of 2008 primarily related to severance payments to departing employees, including approximately $1.2 million of stock-based compensation expense.
As a result of the realignment of personnel and programs, 2008 operating expenses are now expected to be in the range of $47 to $52 million, and net cash used in operating activities to be in the range of $43 to $48 million, according to the company. As of Dec. 31, 2007, Nuvelo had $103.6 million in cash and cash equivalents, short-term investments and restricted cash.