In another indication that proteomics research may find more immediate application in the search for disease markers, Syn X Pharma said last week that the US Patent and Trademark Office will soon approve its patent application covering a potential diagnostic marker for Alzheimer’s disease.
The marker, glutamine synthetase (GS), is the second disease marker that Syn X has discovered with the help of its proteomics platform. In October 1999, the Toronto-based company signed an agreement with Genzyme Diagnostics, a division of Genzyme, to develop and market a panel of antibodies against protein markers whose presence helps to characterize stroke. While the US PTO has not formally issued Syn X a patent on the use of GS as a marker for Alzheimer’s, it has sent the company a “notice of allowance,” and a patent award usually follows six to eight weeks later, said Rod Wilson, Syn X’s chief operating officer.
Wilson said that the company’s studies of GS, a protein previously characterized in sheep but not in humans, have attracted the attention of several pharmaceutical and large distributors of diagnostic tests. A Syn X spokesperson said that one or all of the three players in Alzheimer’s treatments — Novartis, Johnson & Johnson, and Roche — had expressed interest in partnering with Syn X to commercialize the test. The pharma companies are interested in the GS test because it could help identify early stage Alzheimer’s patients who might respond better to therapeutics currently on the market.
In fact, one undisclosed big pharma company paid Syn X an undisclosed fee in January to enter into a standstill agreement, preventing Syn X from negotiating with other partners for one month. That agreement has expired, and Syn X continues to negotiate with five potential partners, Wilson said.
While Syn X’s potential diagnostic test for Alzheimer’s disease tests only for GS, Wilson said the company had also come across several putative therapeutic targets for the disease, which Syn X also hopes to license to pharma partners. Syn X discovered that GS was the most consistent indicator of the early stages of Alzheimer’s using its gel- and mass spectrometry-based proteomics platform, he said. “GS was head and shoulders above the rest,” he added.
In February, Syn X scientists published a paper in the journal Clinical Chemistry describing an ELISA assay for GS, and the results of a study using the assay to measure the levels of GS in 153 healthy patients and 33 patients with some form of dementia. Among other results, the study found that of the 14 patients suffering from some form of dementia other than Alzheimer’s, only one had elevated serum levels of GS.
Like many proteomics companies, Syn X hopes to fund its own in-house drug discovery programs through out-licensing markers, and helping identify patient cohorts that might respond to certain therapeutics in clinical trials. “We’re not a diagnostics company per se; we’re a proteomics company, but the lowest hanging fruit as far as commercialization and funding further research is in diagnostics,” Wilson said. “That’s a real speed-to-revenue strategy on our part.”
Syn X, which was founded in 1997 as Skye PharmaTech, has built its proteomics capabilities around chromatographic techniques for removing high abundance proteins from serum, followed by 1D and 2D gel separation technologies. To identify the separated proteins, the company uses Thermo Finnigan DECA X-100 electrospray ion trap, SELDI-TOF, and Applied Biosystems MALDI QSTAR mass spectrometers, Wilson said.
The company also employs confocal microscopy to study the protein-protein interactions of fluorescently-labeled target proteins, and has an in-house group that can develop monoclonal mouse antibodies, polyclonal goat antibodies, and single-chain antibodies in E. coli, he said.
Wilson said Syn X has also received approval from the Medical Devices Bureau of the Therapeutic Products Programme at Health Canada to conduct a prospective clinical registration trial at 10 health centers in the US and Canada. The trial will help validate the efficacy of GS as a diagnostic, and help support the company’s Pre-Market Application for the diagnostic test to FDA.