Archive for Friday, June 27, 2008
Human testing of cancer drug to start
June 27, 2008
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Westwood When Deatta Lackey stared into the mirror after she began losing her hair — a result of her body responding to the chemotherapy battling her ovarian cancer — she wondered how her husband, Mike, would ever find her attractive.
“I remember my ears, sticking out of my head,” she said.
Through choked-back tears, Lackey described her battle with ovarian cancer that led her to support the development of Nanotax, a new cancer treatment drug. Nanotax was developed through the Kansas University Cancer Center, Lawrence-based CritiTech and researchers on the Lawrence campus.
And on Thursday, the cancer center announced it would begin Phase I human testing of the drug, which is primarily directed toward ovarian and abdominal cancers. This is a major step that will allow researchers at the cancer center to begin testing on a group of 18 to 21 cancer patients.
University officials are lauding the new drug, which takes the commonly used drug Paclitaxel and breaks it into smaller “nanoparticles.” That should make it easier for cancer patients’ bodies to absorb Nanotax.
Dr. Roy Jensen, director of the KU Cancer Center, said because the current version of the drug is so insoluble, it has to be released into the body through a castor oil/ethanol mixture.
That mixture is often blamed for common and often-painful side effects.
According to the National Library of Medicine, these can include nausea and vomiting, loss of appetite, change in taste, thinned or brittle hair, along with various aches and pains.
“It wasn't so much the drug as what was being used to dissolve it that did the damage,” Jensen said. “It was a nasty thing.”
The hope is that by further breaking up the drug, doctors will be able to either subdue, or completely eliminate the side effects.
Kansas University has shown particular interest in the drug because the new technology — which breaks the drug down into individual, water-soluble molecules, allowing it to be better absorbed by the body — is a KU discovery.
Nanotax is KU’s first “bench to bedside” drug, meaning it was developed and will be fully tested by the university, or university-related entities. It also means the cancer center is one step closer to a National Cancer Institute designation.
Karen Kelley, associate director of clinical cancer research, said the first phase of testing will take 12 to 18 months. Depending on how well the new drug works, a second phase of testing with a larger group would follow shortly after.
Sam Campbell, president of CritiTech, told those gathered at a press conference at KU Medical Center's Westwood campus that he had high hopes for the drug’s future.
If the drug receives final approval from the Food and Drug Administration, the university will receive a percentage of the profits. Erica Brown, cancer communications manager, said a set percentage had not yet been decided.
But for survivor Lackey, she said she would support any developments that would prevent others from suffering what she did as a result of her cancer and subsequent treatment.
“I knew my faith would get me through this trial,” Lackey said.
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27 June 2008 at 4:51 p.m.
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notnowdear (Anonymous) says…
We don't need another DRUG that poisons and is only 12% effective like a lot of chemos are. We need immunotherapy, which is indeed the future of cancer treatment, using your own immune system to combat the cancer!!
Sign petition on link below:
http://www.PetitionOnline.com/access2/pe…
Cancer Advocates Support The Access Act
To: U.S. Congress and Senate
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.3046 H.R.6270). Congress now has an opportunity to help save and extend the lives of cancer patients and others with serious life-threatening illnesses, thanks to the recently introduced Access, Compassion, Care, and Ethics for Seriously Ill Patients Act. The Access Act creates a new approval mechanism called Compassionate Investigational Access (CIA) for patients who cannot wait. Patients receiving a CIA drug must suffer from a serious or life-threatening disease, be out of approved options and unable to gain access to a clinical trial. Patients must also provide informed consent, and allow the collection of clinical data from their experience with the drug, so we will all know more about the safety and efficacy of new therapies before they are approved for wider use. House initiating sponsor Representative Dianne Watson (D-CA): “The activism of the AIDS community in the 1990s expedited the marketing to the general public of promising antiretroviral drugs. Sadly, the expedited approval of promising new drugs for cancer patients and patients with other life-threatening diseases does not receive the same attention or expedited approval.” A clear example and one of the poster children of “decelerated” approval at the FDA is Provenge, an immunotherapy for dying men with prostate cancer. Over 30,000 men have died since the FDA decision last May to delay Provenge, citing the need for more data. Provenge has shown activity and efficacy in every one of the six trials where it has been studied including three phase three trials. The FDA looked at the phase three trial that showed the median (midpoint) survival benefit was 4.5 months but the mean (average) survival benefit was much better: 34 percent of all men receiving Provenge were alive after three years compared to 11 percent of those who did not. In the last 45 years, chemotherapy is the only medicine approved to treat terminal prostate cancer. I urge Congress to support and pass the access Act (S.3046 H.R.6270).
Sincerely,
The Undersigned
27 June 2008 at 5:05 p.m.
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notnowdear (Anonymous) says…
Sorry about that, Scott. Didn't mean to offend and differ. It is just that I am not at all fond of chemo.
Chemo kills.
Chemo killed my family member.
I will never do chemo, … ever.