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GMU's Petricoin Partnering with VC Young on Firm Facilitating Molecular Profiling of Cancer Patients

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George Mason University researcher Emanuel Petricoin and venture capitalist Dendy Young have partnered on a concierge medicine company aimed at bringing personalized cancer treatment to the community hospital setting.

Named Perthera, the McLean, Va.-based firm launched in March and has since facilitated genomic and proteomic tumor analyses for roughly 70 patients, Petricoin told ProteoMonitor.

Perthera does not perform these analyses itself, Petricoin noted, but, rather, provides its customers access to "best-in class" molecular profiling assays. Currently, the company offers patients exome sequencing from Foundation Medicine; genomic, proteomic, and immunohistochemical profiling from Caris Life Sciences; and phosphoproteomic profiling from Theranostics Health, where Petricoin is a co-founder and chairman of the scientific advisory board.

While in theory, patients and their physicians could contact these firms directly, the logistics involved make this impractical for most community hospital doctors, Petricoin said. Perthera, he said, is intended as "a gap-filler" for handling the many steps involved in obtaining and sending out patient tumor samples to molecular profiling firms and returning assay results.

"All of the things you have to do – organize the tumor biopsy, have the tumor sent out to the various companies, get the data back, aggregate that data, bank the tumor – there's really no infrastructure in place for that in the community setting," he said. This, he noted, is despite the fact that roughly 95 percent of tumors are treated in the community setting.

"So if you're out in the middle of Danville, Virginia, for instance, and you have cancer, you either have to go to someplace like Memorial Sloan Kettering or MD Anderson to get molecular profiling done, or else you don't get it done," he said.

The idea for the company, Petricoin said, emerged from a tour he gave Young of his lab at George Mason. Petricoin and his GMU colleague Lance Liotta have done considerable work on proteomic and phosphoproteomic profiling of tumors.

Most recently, the pair used their reverse phase protein array technology – which is also employed by Theranostics Health – along with Caris Life Sciences' Target Now service, to develop molecular profiles of tumors from 25 metastatic breast cancer sufferers participating in a clinical trial sponsored by the Side-Out Foundation (PM 6/7/2013). By using these profiles to guide treatment, the Side-Out researchers were able in 13 of the 25 subjects to extend progression-free survival by more than 30 percent compared to their last treatment regimen.

Upon learning of this work and advances in molecular profiling more generally, Young asked why "patients weren't lined up out the door to take advantage" of such techniques, Petricoin said.

"And I told him that there are some logistical reasons why that is the case," he said.

For instance, he noted: "Who is going to make sure the interventional radiologist collects the tissue correctly? Who is going to cut up the tissue and send it to these different labs? Then who is going to bird-dog these companies to make sure the tissue was received and that they are processing it in a timely manner. And then who is going to synthesize all these reports? The oncologist isn't going to synthesize three or five different reports. They have, like, 15 seconds to review any given report."

Perthera, Petricon said, handles all aspects of this process, from making sure the tumor samples are taken properly for each type of assay to returning a streamlined report with information on any clinical trials or drugs a patient might be eligible for based on their profile. The company currently has seven employees. It has also put together a medical review board consisting of oncologists at various cancer centers that are involved in determining recommendations to be included in the reports returned to patients and their physicians.

Perthera's offerings could prove particularly useful in light of the ever increasing number of targeted cancer therapies available, Fred Smith, a Chevy Chase, Md.-based medical oncologist, told ProteoMonitor.

"There's this plethora of new drugs that are interesting and exciting that are non-chemotherapeutic and that have the potential for more efficacy with less toxicity because they act on certain targets that cancer cells display," he said. "And the point is to find whether those cancers have those targets."

Smith has thus far used the company's service for 12 of his patients, and, he said, in two of those cases he changed his course of treatment based on the results of the molecular profiles.

"The recommendations are not 100 percent by any means," Smith said. "But at least they are there. And that is why I do it."

He added that one of the most valuable parts of Perthera's service is harmonizing the sometimes disparate molecular profiles.

"The issue is there is the fact that there are many companies going about it in different ways and sometimes you have the sense that you don't know which company to pick," he said. "Because Caris might give me one set of data and Foundation a different set of data. And so how do you marry them?"

Prothera's service is aimed at patients with advanced, progressing metastatic cancer and costs $5,500, none of which is currently reimbursed, Petricoin said, though he added that the company does work on flexible payment plans for patients unable to afford the fee. Billing for the tests themselves is handled by the individual assay companies.

While Perthera currently offers access to assays from Foundation Medicine, Caris, and Theranostics, the company may add new firms and assays to its offerings in the future, Petricoin said.

"We are constantly surveying the levels of evidence that different companies are offering," he said. "It's basically a [combination] of the amount of tissue needed, the scientific and medical validity, and the turnaround time that we take into consideration."

Additionally, the assays "have to be synergistic," he noted. "We don't want to send tissue out to five different places for RNA-seq. We basically use the facility that is best in class [for a given assay type]."

Beyond providing access to the assays, Perthera is also following patient outcomes, and, ultimately, the company hopes to build a molecular database that will allow it to determine which markers are performing best and to what extent the molecular profiles are improving patient response to treatment.

Currently, Petricoin said, it's too early to say whether or not the service has had any effect on patient outcomes, a fact that, he noted, has made launching the business something of "a grind."

"These community doctors are pretty pessimistic, and rightfully so," he said. "They want to know, 'How do you know this really works?'"

Smith likewise noted that it was too early for him to say whether using Perthera had improved his patients' outcomes.

"Twelve [patients] is a very small number, and so I would have to say that I could not answer that question one way or another," he said. He added that he is having Perthera oversee his cases to try to correlate the tests with actionable findings with actions and, ultimately, with patient outcomes.

Roughly 80 percent of Perthera's 70 patients have signed up with the company in the last three to four months, Petricoin said, adding that things are "definitely ramping up." Around 80 to 90 percent of these patients have come from the community hospital setting, he noted.

At the moment, Perthera is "focused on locking down relationships in the Washington, DC area, but, Petricoin said, the hope is that it could ultimately be a global business. "You're only a FedEx flight away from a patient," he said. The company has processed tissue for one international customer to date, a patient in London, he noted.

The company is currently running on start-up funding provided by Young and another investor and its board consists of Young and Petricoin. Additionally, Perthera has hired Michael Pishvaian, an assistant professor in hematology and oncology at Georgetown University's Lombardi Comprehensive Cancer Center, as chief medical officer, and Howard Federoff, executive dean of Georgetown University School of Medicine, as a senior advisor.

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