THE RACE FOR A CURE FOR CANCER 11/3/98
phillyburbs.com
After years of research and setbacks, Cell Pathways is waiting for FDA approval of its new cancer drug.
By STEVE WARTENBERG and LIZ JOHNSON
Courier Times
For Horsham-based Cell Pathways, developing a cancer drug has been as uncertain as being diagnosed with the disease.
From the start, the company's head researcher Rifat Pamukcu knew he had a promising compound with exisulind.
Put on the U.S. Food and Drug Administration's fast track in 1994, it's taken the company five years to get through the trials required for FDA approval. In February, the company got its own out-of-remission scare when its third and final study found the drug had no more effect than a placebo. The news sent the company's stock plummeting from its high of $29 a share to $9.15, which it closed at yesterday.
Investors gave the company their own prognosis, filing a series of class action suits seeking unspecified damages. Those suits have been consolidated into one. In a company press release, Cell Pathways said the suits are "without merit" and that it will "vigorously defend itself."
But in the eight months since, company officials have had time to sift through the results. They found that some of the patients in the final round did not meet the qualifications for the drug study and skewed its results, said company President Robert Towarnicki.
In June, company officials met with the FDA to discuss the problem. The company resubmitted its application in August. When the FDA didn't refute the findings, it filed a new drug application in October.
Now the biotech is waiting for the FDA's final verdict on the drug, which aims to kill cancerous cells while leaving normal cells alone. Approval could take anywhere from six to nine months, said FDA spokeswoman Susan Cruzan.
The stock is rated a "buy/hold" by the one analyst who tracks it. The company is expected to lose money through 2000 , even if the drug is approved, according to a report issued by Multex.com.
But from a medical perspective "this is very promising," said Randall Burt, chief of gastroenterology at the University of Utah, who has tracked Cell Pathway's research from the start.
"It only seems to affect the abnormal cells and causes the cell death (of the pre-cancerous cells) to return to normal," he said. "This is the key since cancer is basically cells that grow too fast and die too slow."
The company was founded by Pamukcu and his patient, the late Floyd G. Nichols, in 1989. Nichols suffered from Familial Adenomatous Polyposis, a rare disease that starts with thousands of pre-cancerous polyps growing on the inner lining of the colon. Left untreated, it develops into colon cancer. Most victims die by the age of 50.
Nichols was 35 when he went to Pamukcu with news that an arthritis drug, Sulindac, had been used to treat FAP patients with success. It made the polyps mysteriously disappear.
"Within three months, his polyps were gone," Pamukcu said. "It was the most remarkable thing I'd ever seen."
After closer study, Pamukcu found that Sulindac "is converted by the liver into two compounds," he said. The first reduced inflammation. The second seemingly had no effect.
"We found that the second metabolite didn't have all the gastric side effects and was killing every cancer we threw at it," Pamukcu said. "We felt as if we had a tiger by the tail."
Nichols chipped in his own money and they formed FGN Inc. - his initials.
"Anyone can have vision," Pamukcu said. "But if you don't have the entrepreneurial skills, if you don't have money, you can't do great science."
So Nichols tirelessly raised funds while Pamukcu worked in the lab.
Still, they were a long way from a cure, and Pamukcu and Nichols went through a series of ups and downs. By 1993, they were ready to test their metabolite on people with FAP.
As Pat Weidner knows all too well, FAP is a genetic disorder.
The Ohio woman inherited it from her father and has passed it on to her two children. All three had to have most of their colons removed.
Weidner is part of the trials.
"That can perforate your colon," she said. "That happened to me in 1991, and I almost died." Equally unappealing was removing the remainder of her colon. In 1993, she began taking Aptosyn.
Although this is great news for Weidner, it's even better news for her children - and their future children. If and when the gene is detected, they can begin taking Aptosyn and may never develop the deadly polyps.
Nichols died in 1996 from stomach cancer. Two years later, Cell Pathways acquired Tseng labs, a Newtown Township computer company that had sold most of its assets but remained listed on the Nasdaq stock exchange. The acquisition gave Cell Pathways the cash it needed to become a public company. Two weeks ago, Cell Pathways raised another $14 million in a private offering. The money will be used for additional research, namely to show that the drug can treat prostate and breast cancer.
"For (FAP) it's a small, but very needy and significant market," said Cell Pathways' Towarnicki. "It's these other (cancers) where the major market opportunity lies."
"I'm not a magic-bullet kind of guy," Pamukcu said. "No one agent treats or cures every cancer. We're adding to what's already out there."
Wednesday, November 3, 1999
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