Nothing really buys time for patients with terminal forms of melanoma, a type of skin cancer. Not chemotherapy, not targeted antibody drugs, not genetic-based antisense treatments. But Lexington, MA-based Synta Pharmaceuticals should find out within weeks whether or not it has made a breakthrough with a new approach.
Synta (NASDAQ: [[ticker:SNTA]]) is on pins and needles now, as it awaits results early this year from a final-stage clinical trial that will determine whether its experimental drug, elesclomol, can slow down the spread of metastatic melanoma. The study, called Symmetry, enrolled 630 patients who got the Synta drug in a once-weekly intravenous infusion along with paclitaxel chemotherapy or the chemo drug alone. If successful, Synta could apply for FDA approval before the end of this year.
This trial is the first major test for a new class of cancer drugs Synta is developing. The treatment is designed to amplify the amount of oxidative stress in the body, which is thought to nudge cancer cells past a breaking point in which they trigger a self-destruct mechanism known as apoptosis. This same effect does little to healthy cells, because they contain lower levels of these reactive oxygen molecules, and they have a natural ability to send in anti-oxidants to keep them in balance. If the Synta technique works in this trial, it could offer a new form of treatment with minimal side effects for patients with multiple forms of cancer. Melanoma alone was diagnosed in 62,000 people in the U.S. last year, and is estimated to kill 8,400 people annually, according to the American Cancer Society.
“We have 200 people at the company, and I’ve never seen people so excited and full of energy in my life,” says Synta CEO Safi Bahcall. “To use the football analogy, we are inches from the goal.”
Synta has been on an unusual corporate journey to get to this point. Bahcall, formerly a pharmaceutical and investment banking consultant at McKinsey & Co., spotted an opportunity to build a new company in 2001. What he found was a group of 50 medicinal chemists in the Boston area who were working at a research branch of a joint venture owned by Japanese pharmaceutical company Shionogi. The chemists, led by Lan Bo Chen, a professor of pathology at Harvard Medical School, had spent a couple of decades scouring the world of chemistry for unique compounds that might have potential as cancer treatments. They had built a deep library of compounds, with chemical screening capabilities, he says.
The catch was that the team was all about pure science, Bahcall says. They had no animal testing capability, much less clinical trial development skill or marketing muscle. The parent company wasn’t focused on cancer drug development, so the scientists were frustrated they couldn’t get their work to move forward, Bahcall says. “It was a very difficult parent-daughter relationship,” Bahcall says. “It was an incredible diamond in the rough.”
Bahcall lined up meetings with some of his New York investment contacts. “I said to them, ‘We have an amazing opportunity here, a drug discovery engine sitting on a terrific pipeline. It’s all early stage, but what you have here is the heart and soul of a small Merck.” They bought into the idea,
