March 17, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Australian biotech Sirtex Medical has hemorrhaged more than $1 billion in market value after the company said it had flunked a clinical trial for its novel liver cancer therapy, news that sent its shares into a freefall of as much as 55 percent Wednesday.
Sirtex had conducted the Sirflox (SRX) study as a first-line treatment of non-removable colorectal cancer. But results did not find the treatment to be a significant improvement over standard chemotherapy.
“Based on the preliminary analysis just completed, the primary endpoint of the Sirflox study was not achieved,” Sirtex said in a statement today.
The international, multi-center, randomized controlled study enrolled over 500 patients with mCRC whose disease was non-resectable and had spread to either the liver alone or the liver plus a limited number of sites outside the liver, including lymph nodes and the lungs.
Patients were randomised to receive either a current first-line systemic chemotherapy regimen using FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) with the option to receive bevacizumab (Avastin) or the same chemotherapy with the addition of a single administration of SIR-Spheres Y-90 resin microspheres.
“The preliminary analysis shows that adding SIR-Spheres Y-90 resin microspheres to a current first-line systemic chemotherapy regimen for the treatment of non-resectable metastatic colorectal cancer (mCRC) does not result in a statistically significant improvement in the overall Progression-Free Survival (PFS),” said Sirtex.
The company did say, however, that the preliminary analysis showed that SIR-Spheres Y-90 resin microspheres did result in a statistically significant improvement in Progression-Free Survival (PFS) in the liver. That news had some analysts remaining optimistic.
Australian Ethical Investments portfolio manager Andy Gracey told the Sidney Morning Herald “not all is lost,” and said more information is needed before investors entirely abandon Sirtex stock.
“We really need stronger data around the recruitment in terms of how many patients were recruited that had cancers outside the liver,” Gracey said. “It’s definitely working in the liver which is exactly what it has been designed for."SIRFLOX looked at metastatic colorectal cancer, which is when cancer starts in the bowel and moves to the liver. Sirtex has three other clinical trials running at the moment that focus on cases where the primary cancer starts in the liver”.
“I wouldn’t, at the moment, be assigning Sirtex to just salvage therapy,” he said.
BioSpace Temperature Poll
After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? Tell us your thoughts.
