Kirkland firm's woes bring sudden halt to cancer-drug trial
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Several researchers conducting the clinical trial of the drug said they had never heard of a drug trial ending like that. And some patients involved in the project were devastated.
"It's very disappointing. ... Just the fact that they'd begin a study and then stop it, that they would be allowed to do that, is just amazing," said Nancy Merha of Napa, Calif., who has moderately advanced ovarian cancer and was being treated in Seattle as part of the project.
In a separate trial, the drug also was cut off from some of 84 patients in a very advanced stage of prostate cancer. But Cytran officials said most already had completed the trial.
Cytran officials informed physicians at 19 medical centers nationwide last month of the trial's cancellation. These included the University of Washington and Fred Hutchinson Cancer Research Center in Seattle.
The drug was being tested as a supplement to standard chemotherapy for ovarian cancer. Scientists believe it may kill tumors by stopping the blood flow to them and boost patients' immune systems. Researchers began enrolling patients a year ago, hoping to have 180 participants; each patient was to have been treated and analyzed for six months to one year.
"We really did all in our power to keep the trial open," said Anne Bugge, who was Cytran's vice president for communications. "We looked for other (business) partners, we looked for additional funding sources, we reduced staff. But in the end, we didn't have a choice."
Bugge said there may be a buyer for the company's assets within the next two weeks. She said the potential buyer, whom she declined to identify, may eventually be interested in exploring the drug's possibilities. She did not speculate on a resumption of trials.
Cancer patient Merha says her initial anger with the company has settled into a deep, troubling disappointment. She was greatly encouraged by early reports of the drug's potential. She had hope again.
"You tend to do that when you have a dreaded cancer," she said. "If something comes around that gives you hope, it's very exciting stuff."
Company officials said the small, 11-year-old firm got in trouble when the drug IM-862, or gluphanide, was not shown to be effective in a separate trial involving treatment of an AIDS-related disease, Kaposi's sarcoma.
The company had counted on incentive revenues from a pharmaceutical business partner, Alza in California, if the sarcoma trial was successful and the drug looked like it would be marketable.
Physicians running the ovarian-cancer trial in the medical centers were surprised and frustrated that the IM-862 trial collapsed because of bankruptcy.
"I feel very bad for the patients. We made a commitment to them. We thought it was a potential help," said Dr. Leona Holmberg, a Hutchinson-center oncologist and co-director of the study.
Holmberg said the experience should be a lesson to medical centers to examine carefully their relationships with sponsoring companies and to somehow ensure there are safeguards to protect their commitment to patients.
Dr. Shashi Lele, chairman of gynecological oncology at the Roswell Park Cancer Institute in Buffalo, said the trial ended up being "a waste of time for the patients ... and for us, too."
After the drug trial was closed, Hutchinson-center officials tried to obtain the drug and continue the study for the Hutchinson and UW patients. But Cytran officials said they would not release the drug because they were responsible for monitoring the quality of the medication and the Hutchinson center was not set up to do that.
A U.S. Food and Drug Administration representative said Cytran did not violate any federal regulations in closing the trial and not continuing to supply the patients. "At any time, a sponsor may withdraw ... for any reason," said Jason Brodsky, an FDA spokesman.
Clinical trials sometimes are closed early because the drug is found to be unsafe or because the evidence is so strong that the drug helps patients and can be prescribed for others. Closing one for bankruptcy had been unheard of, several researchers said.
Cytran officials said a previous, smaller trial of IM-862 seemed to help very advanced ovarian-cancer patients who already had received extensive chemotherapy. About 30 percent who took the drug survived an additional three months to one year.
"That encouraged us to plan and launch this (recent) trial. We moved it to patients who were earlier in their disease course because we thought it would help," said Dr. Moise Khayrallah, former Cytran vice president for clinical affairs.
Peter Spurging, former chief financial officer, Khayrallah and Bugge said it was very difficult for them to close the trial. Talking to patients about the closure "was the hardest part," Khayrallah said.
Cytran officers and researchers noted, however, that no one knew for sure if IM-862 would help patients. That was the reason for the trial. They also stressed that all patients received the proven, standard chemotherapy for their disease.
Khayrallah said a few patients told him they may try to obtain IM-862 from Russia, where it was originally developed to prevent infections in soldiers and is still sold. He said he told them the cities in which it may be available, but that the dosage is different from theirs and that it was their decision alone to take the drug.
Merha may try to do that. But she and her family are still devastated by the drug trial's cancellation and their dashed hopes for the drug's potential.
"It's like you're drowning at sea, someone throws you a life preserver, pulls you up to the boat, then cuts the line. That's how she felt," Frank Merha said of his wife.
Seattle Times business reporter Luke Timmerman contributed to this report. Warren King can be reached at 206-464-2247 or wking@seattletimes.com.