The year 2013 was a big one for Celator, the Ewing-based biotech company that is researching new ways to mix chemotherapy drugs. In June the company moved from 303 College Road East to the Princeton South Corporate Center, off I-95, so its staff could have better commutes. In November the company got listed on NASDAQ and raised $39 million.
But the biggest news may be yet to come: the day that its product finally reaches consumers. Celator has been developing its CombiPlex platform for more than a decade (par for the course in the world of drug research) and is still testing applications of its technology. In December the company got the go-ahead to continue its phase 3 clinical trial of CPX-351, a leukemia treatment. The trial, which includes 300 patients, will determine whether the company can seek regulatory approval for its new cancer treatment when it is completed at the end of next year.
Like every company making a new pharmaceutical product, Celator must prove to the FDA and the regulators of other nations that its product is safe and effective. What’s different about Celator is that it’s not developing a new drug at all. The leukemia treatment it’s pursuing consists of two existing, proven chemotherapy drugs, named cytarabin and daunorubicin. The twist is that Celator has come up with a new way to mix the drugs together.
It’s a bigger deal than it sounds. “We’re looking to improve the clinical benefit of the combination,” says Scott Jackson, CEO of the company since 2008. Drugs, when delivered together, have different effects based on the ratio of one drug to the other. Depending on the ratio, they could become less effective or more effective. Celator’s work is based on delivering those drugs in a “synergistic” ratio in which both of the drugs become more effective. In the case of CPX-351, that ratio is 5:1
It’s not as simple as just infusing the drugs in that ratio. “You could put the desired ratio in the drug delivery vehicle, and as soon as you start to infuse, they destabilize, metabolize, and eliminate at different rates,” Jackson says. “We use nanoscale liposomes to maintain the desired ratio.”
Celator’s technology is a liposome — an artificial structure about 1/100th the size of a red blood cell — that is engineered to deliver the drugs at a rate that maintains the synergistic ratio. The product entered stage 1 clinical trials in 2007, and is still years away from seeing use by oncologists. The idea goes back to Vancouver in 1999, when Lawrence Mayer, a research scientist at the British Columbia Cancer Agency, founded the company.
Since then Celator has been involved in researching and developing its CombiPlex platform, as well as several other projects, and raising funds to keep the lights on.
When Jackson came on board, he replaced Andrew Janoff, who was a research-oriented leader. Jackson, 48, has a background in pharmaceutical marketing. He came to the company in 2007 with more than 20 years of experience in the industry, having worked for YM BioSciences, where he was responsible for product marketing, ImClone, Centocor, SmithKline Beecham, and Eli Lilly. He has an M.B.A. from Notre Dame and an undergraduate degree in pharmacy from the Philadelphia College of Pharmacy and Science.
Jackson grew up in northeast Philadelphia, where his mother was a homemaker and his father was a postal worker. He has had a passion for science since he was young, and decided to study pharmacy in college. Along the way, he developed an interest in the business side, and a career in the pharmaceutical industry proved to offer a good mix of those two interests.
Jackson has led Celator through a period of intense growth, especially in the last few months. In 2013, the company brought on board several senior managers, including a chief business officer and a vice president of regulatory affairs. There are now 17 employees working in Ewing and four in Vancouver, where the company’s research and development is located.
Jackson predicts more growth in the next year. “We need to plan for success,” he says. “We are taking the steps necessary assuming the Phase 3 clinical trial is positive.” The clinical trial is not of the “double-blind” variety. That is, the physicians delivering the treatment know which drug they are administering. Normally clinical trials are “blinded” so the researchers will be unbiased in evaluating the results.
However, the clinical trial is mostly studying one key piece of data that is hard to fudge: survival. It would also be difficult to “blind” the researchers because the experimental combination uses an infusion pump, whereas the standard chemotherapy doesn’t. The study will mostly be measuring how many of the late-stage leukemia patients using CPX-351 survive versus patients in the study who are receiving standard chemotherapy. Jackson expects data from the trial to be released as soon as 2015.
Jackson is betting on good results from the trial. “That’s why we brought on board a chief business officer, to commercialize it,” he says. Jackson believes CPX-351 could be just the beginning. Many oncology drugs could benefit from being delivered in precise ratios, and Celator hopes to be at the forefront of that market. “The tech platform has broad potential applications in the area of oncology because many cancers are treated with combination therapies.”
Celator Pharmaceuticals (CPXX), 200 Princeton South, Suite 180, Ewing 08628; 609-243-0123; fax, 609-243-0202. Scott Jackson, CEO. www.celatorpharma.com.