Startup is testing two cancer drugs

An East Providence clinical research startup is in the process of testing two cancer drugs that are intended for patients who have failed previous treatment options.
Pharma Resource, an arm of Infusion Resource, has started trials for both breast and ovarian treatments.
The breast cancer drug is a second-line drug, for patients who have already been through one treatment option, Pharma Director of Research Claudia Ferro said recently. It’s a chemically modified compound that already has been approved to treat other types of cancer, she said.
“It’s being used and tested widely in Europe to treat breast cancer,” she said, “but this is the first introduction in the United States.”
The other trial, for an ovarian-cancer drug, is a third-line test, which makes it a “survival” drug for patients that have undergone treatment by two other methods, Ferro said. It’s for patients that “failed two other treatments and hopefully this treatment – this is part of the hypothesis of the study – won’t fail,” she said. “It could clear disease and prolong life. If they don’t have any other options, patients aren’t likely to clear the disease and prolong life.”
For each patient involved in the trial, Pharma collects data – including the basics: name, age, weight, height, etc. – and does pretrial blood work. And when the trial begins, the pharmaceutical sponsor has strict daily guidelines for the treatment and reports on effects and side effects.
“For this compound, they have a few endpoints. One of the endpoints is finding out whether a 14-day cycle is more effective than a 21-day cycle without increasing possible side effects,” Ferro said. Even with those cycles, each study could take up to a year. “Usually, they’ll do a tail end of the study that’s somewhat compassionate care, where they allow patients to stay on the study, clinically administered for up to a year.” Those treatments, which are free to patients and include diagnostic tests like CT scans and physician evaluations, make clinical trials more appealing for those without health care, she added. “These are very expensive drugs,” she said.
Ferro declined to disclose the name of the pharmaceutical company sponsoring the two cancer-related trials. Pharma has four patients for each trial and the pharmaceutical company has another eight sites around the country conducting the same study.
Pharma is also in the process of a solid-tumor drug study for another pharmaceutical company. Two uterus-bleeding studies are scheduled to begin this month.
Pharma is an arm of the newly formed Infusion Resource. Founded in April 2008, Infusion opened its doors in October 2008. Along with Pharma, the company includes an ambulatory infusion suite, a home health care agency and a pharmacy, Ferro said.
Infusion was founded by CEO Bernard F. Lambrese, CFO Joseph F. Haley and Vice President of Clinical Research Kelly Lambrese, all of whom are partners in a Providence consulting firm, Healthcare Strategies LLC. Along with investment from the founders, it was funded by Rhode Island tax credits and a work force training grant, the company said. It operates out of a newly built 6,500-square-foot facility in East Providence.
Clinical-trial firms like Pharma are becoming more common, Ferro said.
“The pharmaceutical companies are highly competitive and for them to get a drug to market takes 20 years,” she said. “So if they have a drug, they’re always rushing to get them through clinical trials.”
The breast and ovarian-cancer medication trials are at FDA Phase II approval, which means they’re about halfway through the 20-year process, Ferro said. Pharmaceutical companies also do interim analysis while the trials are ongoing and will stop them if there are too many adverse side effects, “because it costs those companies millions and millions of dollars to run a study.” In the past, clinical trials were largely conducted at hospitals or through higher education research. But those entities tended to work at a slower pace than a smaller, private clinical trial company, Ferro said. Working as quickly as regulation and safety will allow is essential, she added.
“As always, as with any new compound, the first company to come to market with the drug has the largest market share,” Ferro said. “So that’s what they’re all really competing against.”
Still, the medicine hitting the market today in many cases was initially created in the 1980s.
And a clinical trial can take months to get under way. It first requires the pharmaceutical sponsor to file regulatory forms with the U.S. Food & Drug Administration and submit study guidelines to an FDA-approved private Institutional Review Board.
“Then [the sponsor] has to visit the site and say, ‘Yes, they’re capable of conducting the study.’ Only then do they award the site the study,” Ferro said.
Then a company like Pharma has to file regulatory forms with the FDA “and then, when you’ve done all that, they ship you out the medication and any other specific supplies,” she said.
Because of the prolonged process, Pharma has started applying for a lot of studies.
“We probably have a pipeline of 100 studies that we’ve compiled [applications for] since October,” Ferro said. “Sometimes you have to have 100 in your pipeline to have 20 active or just 10 active.” •