Nov 27, 2009
Tokai eyes novel weapon to battle prostate cancer
Tokai Pharmaceuticals has begun a clinical trial for a new prostate cancer drug candidate after quietly raising cash over the past two years, including $22 million in May. The company expects to have results from the Phase 1/Phase 2 trial by the first half of 2010.
The May funding round brings the amount the Cambridge-based company has raised in all so far to $33.5 million.
Tokai, launched by venture capital firm Apple Tree Partners, has mostly kept quiet until now. The company came to be after Apple Tree founder and Tokai CEO Seth Harrison went looking for a promising drug target to form a company around — and Chief Scientific Officer Scott Chappel was looking to take a shot at a disease that had hit his family.
“After Lupron failed, my father’s doctor called to say, the next thing we have is chemotherapy. I was quite shocked there was nothing else,” Chappel said.
Like many oncology companies today, Tokai starts with the premise that traditional chemotherapy, with its toxic side effects and limited efficacy, is unacceptable. And Lupron, a common treatment that shuts off testosterone production, often has to be stopped after five years, because tumors find a way to get around the drug.
Chappel approached Harrison after finding a molecule in a research lab at University of Maryland medical school that’s designed to attack the disease from three different angles at once. If approved, it would be the first drug of its kind, company officials said.
Prostate cancer is the most common form of cancer in men and the second most lethal, according to the American Cancer Society. Every year, 60,000 men are diagnosed with what’s known as castration-resistant prostate cancer. The cancer keeps growing, even after the tumor’s supply of testosterone from the testes has been cut off, because the tumor learns to make its own testosterone.
Tokai’s drug aims to inhibit testosterone production in the tumors, bind to the androgen receptors — making it harder to effectively use the testosterone to feed the tumor — and to decrease the androgen receptor levels in the tumor.
If the drug proves successful in all three mechanisms, it would no doubt be a blockbuster. Currently there is a drug on the market, Casodex, that blocks androgen receptors, but does not have the other two effects. The drug brought in $1.26 billion in revenue for U.K.-based AstraZeneca in 2008. There is also a drug target in Phase 3 trials called Abiraterone, which attacks another of the three mechanisms by inhibiting the enzyme that makes testosterone. The drug was developed by Los Angeles, Calif.-based Cougar Biotechnology, which was recently bought by Johnson & Johnson for $894 million.
Tokai, which employs seven and outsources its lab work, is moving forward at a pretty good clip. The company’s Investigational New Drug application — the first step in the Food and Drug Administration approval process — was approved in September. The company has so far opened up eight clinical sites, including one at Dana Farber Cancer Institute, and has begun dosing its first two patients. Since there is a large unmet medical need for new prostate cancer drugs, the FDA process will be somewhat quicker, with combined Phase 1/Phase 2 and Phase 2/Phase 3 trials, versus the more common process of three separate trials.
Harrison said after the initial trial results are in, the company will decide whether to conduct the next trial itself, look to partner with a larger company or look to be acquired.
Julie M. Donnelly can be reached at email@example.com.All news about Tokai Pharmaceuticals