delisted from the NASDAQ exchange in 2004. In 2010, the company gained an influx of cash through a reverse merger with the foundering vaccine developer VaxGen. Shares in the merged entity now trade in over the counter markets under the ticker DDXS. The share price dropped below 30 cents in October of 2012, but has climbed to about $2 a share since then.
Ward, a former board member who became CEO in 2011, says a new executive team and selling strategy have revived the company over the past two years. Revenues rose from $16.3 million in 2011 to $20.7 million in 2012, when the company’s loss was $2.7 million. In diaDexus’ second quarter of 2013, total revenues rose 22 percent compared to the same period last year, the company reported.
DiaDexus is seeking FDA approval for a newer version of the PLAC test that could be used by a greater number of labs in hospitals and clinics. Specialty labs are now diaDexus’ largest customers. Plans are also in the works to develop new types of cardiovascular diagnostics. But the Glaxo trials may also hold out the potential for greater growth.
While diaDexus was striving to expand its Lp-PLA2 testing business, Glaxo was collaborating on the development of darapladib with Human Genome Sciences, which Glaxo acquired in 2011 for $3 billion. The collaboration has already produced belimumab (Benlysta) a new drug for the treatment of lupus erythematosus approved by the FDA in 2011.
Mid-stage trials for darapladib didn’t meet the primary goals set by Glaxo, but the company saw enough promise to launch two Phase III trials with a total of more than 28,000 participants. In those trials, the newer version of diaDexus’s Lp-PLA2 test is being used to find patients with elevated levels of the enzyme.
Summary results of the first trial, called Stability, are expected by the end of the year, Ward says. In that trial, participants with cardiovascular disease are given darapladib or a placebo, along with standard treatments such as statins. Results from the second trial, in participants who have recently been hospitalized, are expected in March.
But more detailed data will be released later, and it may indicate which subgroups respond most to Glaxo’s drug, if any. With the PLAC test, Glaxo will be able to see which participants started with very high levels of Lp-PLA2, and which had more moderately elevated levels.
If the trial participants who received darapladib have fewer heart attacks or strokes than the control group, it could mean that Lp-PLA2 somehow causes stable plaques in the arteries to rupture. But exactly how that happens still remains to be explored, Ward says.
“That’s a difficult question to answer,” Ward says. “And if it’s a risk factor, what causes it to click on?”
