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CST
An imperiled cancer patient finds new hope
By Jan Jarvis
Star-Telegram Staff Writer
ARLINGTON -- Two minutes. That's all it would take for five tumors bulging from Sharon Kane's neck to kill her. It could happen while she was watching television, taking a nap or playing with her two young children.
At any time, without warning, the quarter-sized tumors lined up on her neck could press against her carotid artery and cause a rupture so severe that this 34-year-old wife and mother would die instantly.
This cancer, which had resisted radiation, surgery and all kinds of chemotherapy, was taking away her life second by second.
Left with little hope, Kane and her husband, Jim, began searching the Internet for a miracle. They believe they found it in an experimental biologic treatment -- a part- mouse, part-human antibody called IMC-C225 -- that has not been approved by the Food and Drug Administration.
Although Kane wanted the drug despite any risks that it posed, getting it was difficult because she did not meet the requirements of the clinical trial, such as being off any cancer treatment for 12 months. Nonetheless, with the help of her doctor at Arlington Cancer Center, she was allowed to receive it because her situation was so desperate and the promise of a response so great.
After seven weekly treatments with this new therapy that targets specific cancer cells, Kane's tumors can no longer be detected. For the first time in a two-year marathon of radiation, chemotherapy and other treatments, the cancer is in remission.
For Kane, who keeps the damage that has been done to her neck hidden behind scarves, a chance at surviving is worth any sacrifice.
"This is our best hope," said Kane, who said she has never seen and will not look at her scarred neck.
She has endured so much without improvement. Previous treatments have been devastating for this once energetic young mother, who used to work, care for her family and go nonstop from dawn to dusk. In so many ways, friends, relatives and neighbors have helped the Kanes, who live in Grapevine. But in the end, it is Kane alone who must face the disease's unrelenting attacks.
Radiation, chemotherapy and surgery have left her unable to swallow or eat. She must be fed through a tube in her stomach. Her speech has been impaired by surgery on her tongue, her neck has been disfigured, and her weight has plunged to as low as 85 pounds. She has endured fatigue, pneumonia and excruciating headaches.
After being disappointed so many times, the Kanes are cautiously optimistic, and their medical team is encouraged by the response to the recent treatment.
"That's just unheard of," said Laura Rice, research director at the Arlington Cancer Center. "This drug is like a miracle drug."
Whether the malignancy will return tomorrow or never again, no one can predict. Still, of this much Kane is sure: Without her doctor's willingness to try an unproven treatment, the pharmaceutical company's willingness to provide it and the federal government's willingness to allow her to try it under what is called a compassionate plea protocol, she stood little chance of surviving.
Others facing similar fates and who are less willing or able to do whatever it takes to find a cure most likely will die before this therapy hits the market. As is true with this and all drugs being developed, it will take years, millions of dollars and many clinical trials before it is, if ever, approved by the FDA.
The drug that today holds so much promise for Kane has been more than a decade in the making.
It was the life's work of Dr. John Mendelsohn, now president of M.D. Anderson Cancer Center in Houston.
"He spent 15-plus years working on understanding the mechanism in the stimulation and division of tumor cells," said Dr. Harlan Waksal chief operating officer of ImClone, the company that manufactured the drug.
But developing a drug is one thing. Getting it from the lab to the pharmacy shelf represents an enormous challenge. Faced with the responsibility of making sure that drugs are safe for human use, the Federal Drug Administration is meticulous in its efforts to protect consumers.
For every five drugs that go into human testing, only one is approved to go to market, said Jeff Trewhitt, spokesman for PhRMA, the Washington D.C.- based Pharmaceutical Research and Manufacturers of America.
Despite significant promise and the possibility that this monoclonal antibody -- a substance that can locate and bind to cancer cells wherever they are in the body -- could turn out to be the "magic bullet" that researchers have been looking for, progress in getting the drug approved has been slow.
"We're talking about being able to precisely pinpoint a cancer cell, kill just that cell and leave the others alone," Trewhitt said. "That's safer and more effective than chemotherapy, if we can just make the breakthrough."
But putting the theory into practice has been difficult, he said.
"It's a good, sound theory and it can be done," Trewhitt said. "But making it happen has been slow."
Although monoclonal antibodies have been around since the late 1970s, the complexity of the drug has made getting approval slow.
In 1995, ImClone Systems Inc. in New York began clinical studies on IMC-C225 to evaluate its safety and efficacy.
So far only about 200 patients have used the drug in combination with other therapies, but results have been promising, according to ImClone statistics. In one trial, 13 of 16 patients achieved complete responses and two had partial responses. Studies on animals have shown long-term, tumor-free survival.
Waksal said this is the most advanced of any drugs targeting this type of cancer.
"This is one of the things that is most exciting to us," he said. "What we're working on could change the course of cancer."
The course of Kane's life has already been changed by the drug. She had little hope of surviving until she was given the chance to try IMC-C225.
Many others will never get that opportunity.
Typically it takes 15 years and $500 million to get a new drug to the marketplace, according to PhRMA.
Last year, pharmaceutical companies spent $24 billion on research and development, according to PhRMA. Cancer research alone cost $1.4 billion.
Hampering more rapid development of various drugs is the intricacy of the medications being tested, along with increased regulations to ensure safety and stricter trial requirements.
The complexity of monoclonal antibodies has made the search for a cancer treatment especially difficult. Only one- third of all solid tumors contain cells that are responsive to the drug.
"With this you're looking for something that is very, very hard to find," said Jillian Woollett, associate vice president of biologics and biotechnology at PhRMA. "I don't think you can expect things to happen rapidly. The fact is, we know it's doable but complex."
Since the late 1970s, the number of required clinical trials and patients in each trial have more than doubled. Just wanting to participate in a trial is no guarantee that someone will meet the strict eligibility requirements, Rice said.
Still, the FDA has become more flexible in recent years, mostly due to pressure from consumers. In the case of IMC- C225, ImClone wrote a custom protocol and the FDA, through the patient advocate branch, approved its use, said Dr. Karel Dicke, an oncologist with the Arlington Cancer Center.
"The FDA was kind to us to allow us to use this drug," he said.
For Kane, it made sense to try it even though there were serious risks -- a small percentage of patients risk a life- threatening allergic reaction -- because she had such an advanced cancer and there was a real threat of death, he said.
"The benefit of a response far outweighed the small risk of an allergic reaction," he said.
Her positive response has thrilled researchers at ImClone, Waksal said, but more studies are needed.
A trial for patients with head and neck cancers is now open at Arlington Cancer Center but only to patients who have not been treated within the past 12 months, Rice said. Kane did not qualify for that trial but was given permission to try it.
The highly precise drug appears to be especially effective for patients with advanced squamous cell head and neck tumors, Dicke said, but it could work for others as well.
Other cancers, including renal, colon-rectal and bladder, might also be responsive to the drug. ImClone's drug could be used to treat other cancers soon.
"We think we will finish clinical studies that will allow us to seek approval from the FDA by the end of this year," Dicke said. "And that will allow us get to the marketplace by 2001."
Kane said that if she had not been allowed to receive the drug now, she would never have lived long enough to see it approved. By Thanksgiving, her health had deteriorated so much that she feared she would not live until Christmas. But now, for the first time, she has hope for the future.
"I just want to live," she said as she nuzzled her son curled up on the couch. "I want to see my boys grow up."
Jan Jarvis, (817) 548-5423 |
