Lance Liotta and Emanuel Petricoin have formed a company using technology that they say will help clinicians and drug makers better target cancer treatments.
The company, Theranostics Health, will set out to market a protein microarray technology Liotta and Petricoin developed in-house — a departure for the two researchers, who are probably best known for their work on the Surface Enhanced Laser Desorption/Ionization mass spectrometry platform.
While other technologies can measure protein levels, the assays developed by the two George Mason University researchers allow researchers to look at the activity state of proteins in tissue specimens, they said.
By doing so, researchers can measure the activity of actual protein drug targets in a patient’s biopsy in response to drug compounds, according to the pair. Clinicians can then tailor therapies to the needs and responses of patients.
In addition, Liotta and Petricoin said during a press conference unveiling their company, drug makers can develop potential treatments more quickly and less expensively by knowing how patients will respond to them.
“This technology is about once a patient has cancer, how do you treat those patients? Just give them chemotherapy or radiation therapy?” Petricoin said.
“Having the information about the drug targets in that tumor will allow the physician to make a rational and selected choice of the therapeutics that they have in their armament.
The technology is based on a reverse-phase protein microarray invented by Liotta and Petricoin. They print a cell lysate as a “miniature dilution curve so that we are always within the linear dynamic range of the antibody-analyte interaction,” Petricoin told ProteoMonitor this week.
They print reference standards on the same slide and treat it as if it were an immunoassay. Because they print only 5 nanoliters of material, "a 20-microliter lysate can go a very long way," he said. “In combination with validated phopsho-specific antibodies, it allows us to multiplex the analysis of hundreds of phosphorylation events from a single lysate. And we can do it quantitatively by comparing it to reference standards that we print on the exact same slide."
They then compare their results to a calibrator. Because the inter- and intra-assay coefficients of variance are less than 10 percent with clinical material, the procedure is “very reproducible and has the attributes of a clinical diagnostic in its sensitivity, precision, and accuracy,” Petricoin said.
With their method Liotta and Petricoin said they are able routinely measure and quantify over 100 phospho-specific endpoints from only a few thousand cells.
“This is not possible with any [other] existing technology. We’re now broadening the physician’s view of the drug targets in [a] patient and being able to provide that information in very clear and concise way,” Petricoin said.
The researchers said they have published about 50 peer-reviewed articles describing their technology and illustrating its utility.
Citing statistics from the American Cancer Society, Liotta said that more than 1,500 Americans will die each day from one form of cancer or another this year. During the past week, in two high-profile cases, Elizabeth Edwards, the wife of Democratic presidential candidate John Edwards, and White House spokesman Tony Snow announced their cancers had returned and spread.
According to Liotta, the success rate of most therapies for advanced cancer is only about 20 to 30 percent because the disease is often diagnosed when it has already spread.
“If we could only detect the responders ahead of time and focus our treatment on the responders, we would treat them with higher efficacy and spare the rest unnecessary treatment,” said Liotta.
Private Sector Plans
Theranostics was started with $5 million in Series A funding that closed on Jan. 24. Financing was provided primarily by “high net-worth individuals or trusts,” according to Joseph Reilly, president and CEO of the new company.
“Having the information about the drug targets in that tumor will allow the physician to make a rational and selected choice of the therapeutics that they have in their armament.”
Before joining Theranostics, Reilly was managing director of the Chatham Group, a private investment services firm, where he advised private equity firms on large energy and infrastructure assets. Prior to that, he was CEO of Powertrusion International, a composite technologies company, and president of Heisler Industries, a design and engineering firm.
Liotta is vice president and CSO of Theranostics, which is based in Gaithersburg, Md. Petricoin is vice president of R&D. They will continue doing research at George Mason, they said.
In the first phase of Theranostics’ business plan, it is currently negotiating with undisclosed drug companies to use the technology to identify drug targets and assess therapies during pre-clinical and clinical trials.
As part of its business model, Theranostics will test the effects of cancer drugs on cell lines for drug companies, and extend the drugs into preclinical and clinical trials.
After looking at the cellular circuitry and exposing the samples to new potential therapies, Theranostics can provide information to drug makers that will allow them to assess the effectiveness of their therapies, ultimately improving the quality of the drugs and reducing the cost of clinical trials, Liotta and Petricoin said.
“We’re helping them [shoot] fish in a barrel instead of [shooting] in the Pacific Ocean for those responders,” Petricoin said. “Instead of having a five-year clinical trial that costs $750 million to find 20-percent responders, we’re hoping to redact that trial down to a two- or three-year trial that saves a tremendous amount of money. And you have [a] 60, 70, 80 percent response rate. That’s the optimal goal and the ultimate vision.”
In addition to oursourcing its services to pharma, Theranostics is looking to license their technology to drug companies.
Starting in 2008, after Theranostics expects to receive Clinical Laboratory Improvement Amendments accreditation, doctors and hospitals will be able to send patient tissue samples to a Theranostics laboratory for analysis.