Rockville-based EntreMed Inc. scrambled yesterday to calm the fears of investors and cancer patients after a researcher involved in overseeing human testing of the company's cancer drug said he had seen "no major clinical" response in patients.
EntreMed shares dived more than 30 percent on investor fears that the highly touted drug Endostatin would not reduce the size of tumors in people the way it had in mice. The company's shares lost $12.625 to close at $28.875.
Both the company and the National Cancer Institute senior investigator whose remarks set off the fervid response - Dr. James Pluda - responded yesterday by saying Phase I trials are only used to determine whether drugs are safe in people. They are not a good indication of whether the drugs work - something that is examined in Phase II and III trials, they said."It's too early," Pluda said. "These trials are not designed to assess clinical response" to the treatment.
EntreMed Chief Executive Officer John W. Holaday emphasized the same thing in a late-afternoon appearance on CNBC's "MarketWrap": "You can't evaluate the success or failure of a drug when it's in early testing."
He called the comments, which appeared in yesterday's Boston Globe, "premature."
Still, yesterday's stock-market pummeling - and the fast pace of Internet message board activity on sites related to EntreMed - served as a reminder of how much is perceived to be riding on Endostatin and similar therapies - both for EntreMed and for cancer patients. No one was more aware of that yesterday than Chuck Killian, a Chicago-area cancer patient whose story helped inspire the stock-whipping.
Killian said that on Monday he was removed from the small group of people allowed to receive Endostatin as part of a clinical trial in Madison, Wis., after the size of the tumor in his liver grew more than 50 percent. Food and Drug Administration-approved rules for trial participants require that they be removed under such circumstances, Killian said. After word of his removal spread on EntreMed-related message boards and in the news media, Pluda told the Globe: "I'm not aware of any major clinical response to date" to the drug.
Late yesterday afternoon, Killian was busy returning calls to reporters from around the country, saying he finds it ironic that a drug he so fervently believes in is getting a bad rap, in part because of what happened to him. He credits Endostatin with reducing his pain and increasing his energy, allowing him to swim laps and play a couple of rounds of golf recently. He also said his doctors have told him that he has not developed any new cancerous lesions in the past four months, a time frame that corresponds to when he began receiving Endostatin in a daily intravenous drip.
Killian has lesions in his lungs and liver after cancer spread from his colon. His story was already the subject of discussion in Internet chat rooms because he had been featured in February in a Chicago Tribune article on the treatment."What it comes down to is I'm a fervent believer in Endostatin," Killian said yesterday, saying he is trying to get in a trial for the drug in Amsterdam. "I'm very unhappy that my government is forcing me to look oversees to continue treatment with a drug I felt was prolonging my life."
EntreMed spokeswoman Mary Sundeen said it's too early to tell anything about the efficacy of the treatment, a protein that is one of three treatments the company is developing to keep blood from feeding the growth of diseased tissues.
The company has said the treatments - Endostatin, Angiostatin and 2-Methoxyestradiol - hold promise for treating a leading cause of blindness called macular degeneration, as well as progressive arthritis and cancer.
The treatments are aimed at blocking angiogenesis - the development of new blood vessels. EntreMed even calls itself "the Angiogenesis Company" and has tied its future to the success of the treatments.
Like most young biotech companies, EntreMed is losing millions of dollars as it spends heavily to develop its new drugs.
This isn't the first time EntreMed's shares have taken a ride thanks to speculation about Endostatin and its sister drugs.
Articles about the treatment have put EntreMed shares on a roller-coaster, pushing them up 330 percent one day in May 1998 after the New York Times quoted Dr. James Watson - discoverer of the structure of DNA - as saying that the therapy discovered by Dr. M. Judah Folkman of Children's Hospital in Boston "is going to cure cancer in two years."
Since then, the company's stock has fallen 44 percent.
Pluda's job includes close monitoring of toxicity in patients who are taking Endostatin at the two clinical trials sites overseen by the National Cancer Institute. He said he based his remarks about the effectiveness of the drug on information discussed among researchers at a meeting in March.
He said he does not get such effectiveness data on a "real-time" basis as part of his job at the institute.
Sun staff writer Rona Kobell and Bloomberg News contributed to this article.