San Antonio — With the number of scientists, researchers, executives, and patients involved in any given drug approval process, it’s easy to gloss over the early work that goes into clinical testing, especially when most patient awareness about a drug comes after it gains FDA approval.
For a company like South Texas Accelerated Research Therapeutics (START), which conducts Phase 1 clinical trials for pharma and biotech companies developing oncology drugs, the reward can be even more immediate than just the FDA signature. The San Antonio-based company enrolls more than 700 patients a year in its trials, which take place at clinics it operates in six cities and three continents globally.
“Many of these really good drugs that have been approved, even in Phase 1 they show dramatic responses,” says Anthony Tolcher, the director of clinical research at START. “We do see things that are really satisfying—to see a tumor shrink and a patient to have a partial response or complete response on a new agent.”
Pharma companies often leave enrolling and running clinical trials to companies called contract research organizations. While the CRO industry is dominated by large, global companies like Durham, NC-based Quintiles (NYSE: Q) and Waltham, MA-based Parexel (NASDAQ: PRXL), these larger operators don’t specialize in early stage work.
That’s a gap START is filling, focused solely on Phase 1. START is not a CRO, Tolcher says, but rather a site management organization—with the distinction in part lying in the latter being less regulated or legally liable, according to one FDA explanation. Unlike a CRO—companies that START sometimes works for—site management organizations can’t audit the work they do, nor can they submit recorded data from clinical trials to regulators, Tolcher says.
Regardless, the Texas business is in the midst of expansion; its sixth clinical site opened in Taiwan this week, located at Taipei Medical University. The company expects to begin running clinical trials there as early as May, and may study therapies in as many as 30 patients this year.
The move into Taiwan follows START’s recent expansion into Grand Rapids, MI, where it opened a clinical trials office at the Cancer and Hematology Centers of Western Michigan. START always opens its new operations at an affiliate hospital, from which it receives patient referrals for its Phase 1 trials. Physicians at the hospitals refer patients who haven’t responded to conventional treatments and are seeking an experimental option, Tolcher says.
“When doctors have a difficult problem with someone who is otherwise healthy but has an incurable cancer and they’ve exhausted all conventional therapies, that’s when they get referred to our program,” he says. “We embed ourselves with the largest private practices.”
START also has one practice in San Antonio, which is affiliated with South Texas Medical Center, two in Madrid (at one private and one public hospital), and one in Shanghai at the Fudan University Shanghai Cancer Center. The variety of locations provides START with a diverse patient pool and opportunities to work with both national and multinational pharmaceutical companies. For patients in those cities, it provides access to treatments that people in larger cities—like New York—might only get, Tolcher says.
Tolcher says that START’s researchers—who opened START in 2007 after leaving the Cancer Therapy Research Center, the National Cancer Institute-designated research and treatment facility that’s affiliated with the University of Texas at San Antonio Health Science Center—have performed Phase I work on 25 drugs that eventually received U.S. regulatory approval. The company’s performance is due to a desire to provide clinical trial operations that are consistent and uniform—like Starbucks, Tolcher says.
START is not alone in its work enrolling early-stage trials, with companies like Nashville, TN-based Sarah Cannon—which also lists site management organization services though it also does later stage trial work—and cancer centers such as Memorial Sloan Kettering and Dana Farbar offering similar services. START says the 700 patients it puts through trials a year makes it the largest Phase 1 oncology trial operator.
START researchers have worked with both large pharma and small biotech, including on Genetech’s trastuzamab (Herceptin) and Onyx Pharmaceuticals’ sorafenib (Nexavar). Tolcher says the most innovate drug it has collaborated on is one of the more recent ones: pembrolizumab (Keytruda), a drug developed by Merck (NYSE: MRK) that is one of only a few immunotherapies to win FDA approval.
The drug, which gained approval for melanoma in 2014, has recently been noted to have kept some patients alive for more than three years. One of START’s researchers, Amita Patnaik, who worked on the Phase 1 trial for melanoma, as well as other indications, told the San Antonio Express News about the company being the first researchers in the world to have access to the molecule, allowing them to describe its safety profile.
“We were really the first to get exposure to this molecule and to be able to describe its safety—and also to be able to describe its activity in both melanoma and lung cancer,” Patnaik told the newspaper.
For Tolcher, safety is what it all comes down to with START. But while “you can’t quibble with safety,” Tolcher says, tumor response is still part of the Phase 1 study, which can make observing the effective drugs like Keytruda exciting.
“Seeing a drug go from first patient to approval in 3.3 years, plus with some of these patients cured—the last time we saw something like that in solid tumors was cisplatin (Platinol) in the ‘70s with the cure of nonseminomatous germ cell tumors in testes carcinoma,” Tolcher says. “That’s how long it’s been since we had one drug in some patients being cured. Phenomenal.”