A Medical Device Daily
Blood substitute manufacturer Northfield Laboratories (Evanston, Illinois) reported a wider third-quarter loss as its research and development costs surged, but the company noted progress in the controversial trial of its PolyHeme hemoglobin-based oxygen therapeutic in the treatment of trauma patients.
For the three months ended Feb. 28, losses totaled $6.4 million, or 24 cents per share, vs. $4.8 million, or 21 cents per share, in the year-earlier quarter. Analysts expected the company to post a loss of 25 cents per share, according to a Thomson Financial poll.
The company generated no revenue this quarter or in the year-ago period. Costs, meanwhile, surged to $7.2 million from $5.1 million, due to a 52% jump in research and development expenses to $5.8 million.
At the close of the quarter, the company reported shareholders' equity of $77.4 million, with $80.3 million in cash and marketable securities.
Last month, the company reported that regulators are investigating its development-stage PolyHeme product,
which is being used as an alternative to transfusion for extreme blood loss. PolyHeme is undergoing a late-stage clinical trial.
Public concerns about the safety of the blood substitute arose after a Feb. 22 report in The Wall Street Journal (Medical Device Daily, Feb. 28, 2006). The newspaper reported that Northfield pushed to continue testing the blood substitute without disclosing earlier results, which included the deaths of two patients among 10 who had suffered heart attacks that trial focused on use of Polyheme in elective surgery.
Northfield reiterated that it is cooperating with the staff of the SEC and the Senate Finance Committee with respect to their requests to provide certain information regarding the prior elective surgery trial. The company will also be defending a number of purported class action lawsuits recently filed against it
The company did offer some positive news in its report, noting that 665 patients out of a planned total of 720 total patients have been enrolled thus far in its pivotal Phase III study designed to evaluate the safety and efficacy of PolyHeme when administered to patients in hemorrhagic shock following traumatic injury. The reported enrollment figure the company noted has enabled the study to pass the 90% mark of the planned enrollment.
In a conference call, Steven Gould, MD, CEO and chairman of Northfield, said the company plans to complete trial enrollment in “the second quarter of calendar year 2006.“
Northfield also said it will receive $3.5 million in designated funding for the continued development of PolyHeme as part of the Fiscal 2006 Defense Appropriations Bill, bringing the total defense appropriations for the product to $4.9 million.
The company additionally noted that it has completed its review of multiple proposals for the planned expansion of its manufacturing capacity in Mt. Prospect, Illinois, and is finalizing negotiations on a contract with the Jacobs Engineering Group.
Biomarker shows risk for recurrent heart event
Results from a major new cardiovascular study showed that when measured about 30 days after an acute coronary event such as chest pain or heart attack, elevated levels of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity are an independent risk marker for death or recurrent cardiovascular (CV) events.
Lp-PLA2 activity has been associated with the development and progression of atherosclerosis, a process that may lead to heart attack, stroke or other serious CV events but until now, little information has been available on the prognostic role of Lp-PLA2 in patients following acute coronary syndromes.
Results from this sub-study of the PROVE IT-TIMI 22 (PRavastatin Or atorVastatin Evaluation and Infection Therapy) trial were published this week in Circulation.