Fears have been raised over the safety of a cervical cancer vaccine which health officials plan to give all 12-year-old girls, after it was revealed that the drug has been linked to several deaths.
Three young women are reported to have died days after the drug Gardasil was administered, while the jab is also suspected of triggering "adverse reactions" in 1,700 patients. The figures were uncovered by campaigners who made a freedom of information request in the US, where the vaccine was approved for use a year ago.
Tom Fitton, the president of Judicial Watch, which extracted the data, said: "Reports on the vaccine read like a catalogue of horrors."
The women – aged 12, 19 and 22 – suffered heart attacks or blood clots after being injected with Gardasil, which protects against the sexually transmitted human papilloma virus which causes most cases of cervical cancer. Hundreds of others reported suffering what could be adverse reactions, including paralysis, seizures and miscarriages.
The news comes just days after the announcement that the drug would be added to the childhood immunisation programme.
However, it has not been conclusively proven that Gardasil had directly caused any of the deaths or reported health problems.
Nicholas Kitchin, from Gardasil, manufacturers Sanofi Pasteur MSD, said the fact that symptoms were reported after a vaccination did not necessarily mean they were caused by the vaccine.
A spokesman for the Medicines and Healthcare products Regulatory Agency said no "proven, serious new risks have been identified", but added the effects would be monitored when Gardasil is used in the UK.
Jackie Fletcher, from the vaccine damage support group Jabs, said: "Trials of this jab have mostly been on adults, so we don't have any idea of the long-term effect on children."
Dr John Oakley, a West Midlands GP, said the trials for Gardasil had been so limited that the children taking it would be like "guinea pigs".
Many health campaigners have welcomed the plan to vaccinate British girls, although there have been claims it will encourage teenagers to have sex early.
Source: Telegraph.co.uk
Sunday, November 4, 2007
Temodar and radiation extends survival
NEW YORK, Oct 29 (Reuters) - Four times as many brain cancer patients who received Schering-Plough Corp (SGP.N: Quote, Profile, Research) drug Temodar and radiation were still alive four years after being diagnosed than those who received radiation alone, researchers said on Monday.
The data come from continued observation of patients from a Phase III study whose results appeared in 2005. That 573- patient study showed twice as many patients treated with Temodar and radiation survived two years after diagnosis as those receiving only radiation.
The patients were treated for a rapidly fatal form of brain cancer called glioblastoma multiforme (GBM), which accounts for up to 25 percent of all primary brain tumors.
The follow-up analysis described on Monday showed that 12 percent of those receiving Temodar during and after radiation lived for four years, versus three percent of those receiving radiation alone.
Researchers also noted that patients who survived for four years after being diagnosed were primarily younger than 50 and in otherwise good health, meaning no prior major medical condition.
About 28 percent of such otherwise healthy and relatively young patients treated with Temodar and radiation lived for four years, compared with 7 percent of those who received only radiation.
"Since GBM patients can now live longer, oncologists are monitoring them more closely and a substantial proportion of these patients are being actively treated when their cancer returns, through a combination of treatment options," said Rene-Olivier Mirimanoff, lead author of the study and a radiation oncologist at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.
The four-year follow-up data were presented in Los Angeles at a meeting of the American Society for Therapeutic Radiology and Oncology.
Source: Reuter.com
The data come from continued observation of patients from a Phase III study whose results appeared in 2005. That 573- patient study showed twice as many patients treated with Temodar and radiation survived two years after diagnosis as those receiving only radiation.
The patients were treated for a rapidly fatal form of brain cancer called glioblastoma multiforme (GBM), which accounts for up to 25 percent of all primary brain tumors.
The follow-up analysis described on Monday showed that 12 percent of those receiving Temodar during and after radiation lived for four years, versus three percent of those receiving radiation alone.
Researchers also noted that patients who survived for four years after being diagnosed were primarily younger than 50 and in otherwise good health, meaning no prior major medical condition.
About 28 percent of such otherwise healthy and relatively young patients treated with Temodar and radiation lived for four years, compared with 7 percent of those who received only radiation.
"Since GBM patients can now live longer, oncologists are monitoring them more closely and a substantial proportion of these patients are being actively treated when their cancer returns, through a combination of treatment options," said Rene-Olivier Mirimanoff, lead author of the study and a radiation oncologist at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.
The four-year follow-up data were presented in Los Angeles at a meeting of the American Society for Therapeutic Radiology and Oncology.
Source: Reuter.com
FDA OKs Novartis Cancer Drug
Novartis (NVS - Cramer's Take - Stockpickr - Rating) said Monday afternoon that the Food and Drug Administration approved its second-line treatment for chronic myeloid leukemia (CML), a life-threatening blood cancer that's one of the four most common types of leukemia.
The FDA approved Tasigna for adults with Philadelphia chromosome-positive (Ph+) CML who are resistant or intolerant to prior treatment, including Novartis' Glivec.
Novartis said it will make the twice-daily drug available in the U.S. within days. It was approved in Switzerland in July 2007, and Novartis expects an approval in the European Union by the end of this year. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September recommending the drug be approved. Tasigna was also submitted for approval in Japan in June.
Source: TheStreet.com
The FDA approved Tasigna for adults with Philadelphia chromosome-positive (Ph+) CML who are resistant or intolerant to prior treatment, including Novartis' Glivec.
Novartis said it will make the twice-daily drug available in the U.S. within days. It was approved in Switzerland in July 2007, and Novartis expects an approval in the European Union by the end of this year. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September recommending the drug be approved. Tasigna was also submitted for approval in Japan in June.
Source: TheStreet.com
Friday, September 21, 2007
AstraZeneca's Stock May Get Help From Prostate Drug (Update1)
The following article provides a glimpse of hope for Terminal Stage Prostate Cancer Patients. The European company AstraZeneca has developed a medicine called ZD4054 that could potentially lengthen the lives of terminally ill patients. It seems that we are inching closer and closer to a cure for cancer. Just a matter of when and who.
By Eva von Schaper and Dermot Doherty
Sept. 20 (Bloomberg) -- AstraZeneca Plc is staking the growth of its flagging cancer-drug unit on a prostate tumor medicine that treats lethal forms of the disease.
The experimental therapy, called ZD4054, may lengthen the lives of terminally ill patients in a study released in Barcelona next week. The report may revive the London-based company's shares after a 12 percent decline this year.
AstraZeneca, the U.K.'s second-largest drugmaker, started the final phase of testing in June and is scheduled to file for approval in 2009. About 27,000 Americans die each year of prostate cancer, and analysts say the medicine is likely to generate $1 billion in annual sales. AstraZeneca needs new therapies after scuttling three medicines last year.
``They're not positioned to tolerate another failure with a phase III candidate,'' said Nick Turner, an analyst at Mirabaud Securities in London. ``ZD4054 is important,''
The company, once the world's largest cancer-drug maker, has fallen to fifth, according to Paul Diggle, a London-based analyst with Code Nomura. Its best-selling Arimidex and Casodex cancer treatments, with combined second-quarter sales of more than $770 million, are set to lose patent protection in 2008 and 2009.
AstraZeneca shares rose 9 pence, or 0.4 percent, to 2,427 pence at 10:41 a.m. in London trading. AstraZeneca has lost 25 percent in the past 12 months, while the 13-member Bloomberg Europe Pharmaceutical Index has declined 5.7 percent.
ZD4054 is one of several cancer medicines AstraZeneca is moving further into trials, Chief Executive Officer David Brennan said yesterday at a meeting with reporters. Testing of the drug was pushed up because scientists said it showed better activity than similar compounds in early studies, he said.
Cutting the Flow
The pressure on AstraZeneca to deliver new medicines rose after the heart drug AGI-1067 in April failed to reduce chest pain and other disease complications, the company's latest compound to fall short of its target. The experimental medicine was the fourth one shelved by Brennan. Stroke drug NXY-059, also known as Cerovive, was dropped in October 2006, following Exanta for blood clots in February and Galida for diabetes in May.
``This could be a step back to the front line of cancer for AstraZeneca,'' Diggle said. Only 8 of the 37 analysts whose coverage is tracked by Bloomberg suggest investors buy the company's shares.
The product cuts off the growth of blood vessels tumors need to spread to other organs by blocking the action of a cell protein called endothelin A. AstraZeneca, which has struggled to get wider use of its Iressa lung cancer medicine, is trying for success in a treatment area where other companies have failed.
Rival Failures
ZD4054 is the second therapy to exploit a blood-vessel blocking strategy to interfere with prostate cancer's spread. In 2005, Abbott Laboratories failed to win approval from the U.S. Food and Drug Administration for its experimental drug, Xinlay, which also sought to inhibit endothelin.
A panel of advisers said the company didn't show the drug delayed the disease. It was also linked to a risk of heart failure. Unlike Xinlay, ZD4054 doesn't hamper cell death.
``The risk is high but the reward is also high,'' said Erik Hultgard, an analyst at Kaupthing Bank in Stockholm who has a buy rating on the stock. ``AstraZeneca is very optimistic, and the data should be encouraging.''
Robert Dreicer, a Cleveland Clinic doctor who tested ZD4054, said the way Abbott conducted its study made it difficult for regulators to evaluate the product's usefulness.
``The way the trials were designed was problematic,'' Dreicer said. ``I believe the class is promising and has activity.''
Third of All Cancers
Drugmakers have had setbacks trying to develop treatments for advanced prostate cancer. U.S. regulators in May delayed Seattle-based Dendreon Corp.'s Provenge vaccine for prostate cancer, while GPC Biotech AG, a German biotechnology company, in July withdrew a U.S. application for its prostate cancer drug, satraplatin.
More than 220,000 men will be diagnosed with prostate cancer in the U.S. this year, according to the National Cancer Institute in Bethesda, Maryland. Prostate cancer accounts for about a third of all cancer diagnoses in men, second only to skin cancer.
Investors have lost confidence in AstraZeneca's pipeline after the late stage failures. Analysts estimate that investors are willing to pay about $11.92 for each dollar of AstraZeneca earnings, the second cheapest of European drugmakers. That compares to just over $20.42 for Roche, and $16.50 for Novartis, according to according to data compiled by Bloomberg.
``As many men with hormone-refractory prostate cancer are elderly and frail, we would like to have a drug that hinders hormone refractory disease with few side-effects,'' said Dr. Par Stattin, a urologist at Umea University Hospital in Umea, Sweden. ``There is a big need for such a drug.''
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net ; Dermot Doherty in Geneva at Ddoherty9@bloomberg.net
source: Bloomberg.com
By Eva von Schaper and Dermot Doherty
Sept. 20 (Bloomberg) -- AstraZeneca Plc is staking the growth of its flagging cancer-drug unit on a prostate tumor medicine that treats lethal forms of the disease.
The experimental therapy, called ZD4054, may lengthen the lives of terminally ill patients in a study released in Barcelona next week. The report may revive the London-based company's shares after a 12 percent decline this year.
AstraZeneca, the U.K.'s second-largest drugmaker, started the final phase of testing in June and is scheduled to file for approval in 2009. About 27,000 Americans die each year of prostate cancer, and analysts say the medicine is likely to generate $1 billion in annual sales. AstraZeneca needs new therapies after scuttling three medicines last year.
``They're not positioned to tolerate another failure with a phase III candidate,'' said Nick Turner, an analyst at Mirabaud Securities in London. ``ZD4054 is important,''
The company, once the world's largest cancer-drug maker, has fallen to fifth, according to Paul Diggle, a London-based analyst with Code Nomura. Its best-selling Arimidex and Casodex cancer treatments, with combined second-quarter sales of more than $770 million, are set to lose patent protection in 2008 and 2009.
AstraZeneca shares rose 9 pence, or 0.4 percent, to 2,427 pence at 10:41 a.m. in London trading. AstraZeneca has lost 25 percent in the past 12 months, while the 13-member Bloomberg Europe Pharmaceutical Index has declined 5.7 percent.
ZD4054 is one of several cancer medicines AstraZeneca is moving further into trials, Chief Executive Officer David Brennan said yesterday at a meeting with reporters. Testing of the drug was pushed up because scientists said it showed better activity than similar compounds in early studies, he said.
Cutting the Flow
The pressure on AstraZeneca to deliver new medicines rose after the heart drug AGI-1067 in April failed to reduce chest pain and other disease complications, the company's latest compound to fall short of its target. The experimental medicine was the fourth one shelved by Brennan. Stroke drug NXY-059, also known as Cerovive, was dropped in October 2006, following Exanta for blood clots in February and Galida for diabetes in May.
``This could be a step back to the front line of cancer for AstraZeneca,'' Diggle said. Only 8 of the 37 analysts whose coverage is tracked by Bloomberg suggest investors buy the company's shares.
The product cuts off the growth of blood vessels tumors need to spread to other organs by blocking the action of a cell protein called endothelin A. AstraZeneca, which has struggled to get wider use of its Iressa lung cancer medicine, is trying for success in a treatment area where other companies have failed.
Rival Failures
ZD4054 is the second therapy to exploit a blood-vessel blocking strategy to interfere with prostate cancer's spread. In 2005, Abbott Laboratories failed to win approval from the U.S. Food and Drug Administration for its experimental drug, Xinlay, which also sought to inhibit endothelin.
A panel of advisers said the company didn't show the drug delayed the disease. It was also linked to a risk of heart failure. Unlike Xinlay, ZD4054 doesn't hamper cell death.
``The risk is high but the reward is also high,'' said Erik Hultgard, an analyst at Kaupthing Bank in Stockholm who has a buy rating on the stock. ``AstraZeneca is very optimistic, and the data should be encouraging.''
Robert Dreicer, a Cleveland Clinic doctor who tested ZD4054, said the way Abbott conducted its study made it difficult for regulators to evaluate the product's usefulness.
``The way the trials were designed was problematic,'' Dreicer said. ``I believe the class is promising and has activity.''
Third of All Cancers
Drugmakers have had setbacks trying to develop treatments for advanced prostate cancer. U.S. regulators in May delayed Seattle-based Dendreon Corp.'s Provenge vaccine for prostate cancer, while GPC Biotech AG, a German biotechnology company, in July withdrew a U.S. application for its prostate cancer drug, satraplatin.
More than 220,000 men will be diagnosed with prostate cancer in the U.S. this year, according to the National Cancer Institute in Bethesda, Maryland. Prostate cancer accounts for about a third of all cancer diagnoses in men, second only to skin cancer.
Investors have lost confidence in AstraZeneca's pipeline after the late stage failures. Analysts estimate that investors are willing to pay about $11.92 for each dollar of AstraZeneca earnings, the second cheapest of European drugmakers. That compares to just over $20.42 for Roche, and $16.50 for Novartis, according to according to data compiled by Bloomberg.
``As many men with hormone-refractory prostate cancer are elderly and frail, we would like to have a drug that hinders hormone refractory disease with few side-effects,'' said Dr. Par Stattin, a urologist at Umea University Hospital in Umea, Sweden. ``There is a big need for such a drug.''
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net ; Dermot Doherty in Geneva at Ddoherty9@bloomberg.net
source: Bloomberg.com
Tuesday, September 18, 2007
Millennium Pharma: Velcade cancer therapy shows positive results
Sept 18 (Reuters) - Millennium Pharmaceuticals Inc (MLNM.O: Quote, Profile, Research) said data from a late-stage trial of cancer drug Velcade, in combination with certain other cancer treatments, for the treatment of multiple myeloma, showed statistically significant improvement in all efficacy measures.
In a statement, Millennium said the control arm of the trial was stopped early to allow patients still being treated with the other cancer treatments, melphalan and prednisone, to have Velcade added to their therapy.
Millennium is co-developing Velcade with a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research). (Reporting by Deepti Chaudhary in Bangalore)
Source: Reuters
In a statement, Millennium said the control arm of the trial was stopped early to allow patients still being treated with the other cancer treatments, melphalan and prednisone, to have Velcade added to their therapy.
Millennium is co-developing Velcade with a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research). (Reporting by Deepti Chaudhary in Bangalore)
Source: Reuters
Monday, September 17, 2007
FDA Warns Against Use Of Fentora In Patients With Acute Pain – Linked To Five Deaths – Breakthrough Pain Cancer Drug
Another unfortunate setback for cancer patients. The Fentora, once a promising painkiller for cancer patients, is on the verge of being taken offline.
(Best Syndication) The powerful painkiller, Fentora, which is used for treating pain in cancer patients, is linked to four deaths and a suicide, according to a spokesperson from Cephalon Inc. Fentora contains an ingredient called Fentanyl, which is eighty times more power than Morphine. The drug may have been prescribed for other conditions including migraine headaches, back and bone pain. The company now warns against that.
The Food and Drug Administration (FDA) and the drugs maker warned doctors in a letter. The drug should only be used on cancer patients who are already taking opiod drugs like Morphine. The company wants to make sure that those taking Fentor are tolerant to opiod drugs. The drug should not be prescribed for acute pain or for postoperative pain, according to the letter.
The company says do not substitute Fentora for Actiq or other fentanyl-containing products. Patients should not take more than 2 FENTORA tablets per breakthrough pain (BTP) episode. Patients must wait at leas 4 hours between treatments.
Source: Bestsyndication.com
(Best Syndication) The powerful painkiller, Fentora, which is used for treating pain in cancer patients, is linked to four deaths and a suicide, according to a spokesperson from Cephalon Inc. Fentora contains an ingredient called Fentanyl, which is eighty times more power than Morphine. The drug may have been prescribed for other conditions including migraine headaches, back and bone pain. The company now warns against that.
The Food and Drug Administration (FDA) and the drugs maker warned doctors in a letter. The drug should only be used on cancer patients who are already taking opiod drugs like Morphine. The company wants to make sure that those taking Fentor are tolerant to opiod drugs. The drug should not be prescribed for acute pain or for postoperative pain, according to the letter.
The company says do not substitute Fentora for Actiq or other fentanyl-containing products. Patients should not take more than 2 FENTORA tablets per breakthrough pain (BTP) episode. Patients must wait at leas 4 hours between treatments.
Source: Bestsyndication.com
Friday, September 14, 2007
Targeted drug combos could outsmart cancer
I found the following article very interesting and promising for cancer patients.
Thu Sep 13, 2007 4:42pm EDT
By Julie Steenhuysen
CHICAGO (Reuters) - Cancer cells often have a way of outsmarting new targeted drug therapies, but U.S. researchers said on Thursday a combination of targeted drugs could shut down a tumor's backup plan, resulting in much more effective treatments.
A number of these so-called targeted cancer drugs -- such as Roche's Tarceva and Novartis' Gleevec -- work by blocking the activity of various protein switches that tell the cell to grow. They are known as receptor tyrosine kinases or RTKs.
"They essentially allow the cell to communicate with the external world to sense growth factors that could maintain the survival of a cancer cell," said Dr. Ronald DePinho of the Dana-Farber Cancer Institute and Harvard Medical School, whose study appears in the journal Science.
These protein switches are on the surface of all cells, and they go haywire in a number of cancers.
Drugs that target a single switch have transformed the treatment of some patients with certain cancers -- for instance, Gleevec and chronic myelogenous leukemia.
But they only work in a small percentage of people. And certain tumors, including the aggressive brain cancer glioblastoma multiforme, respond poorly to such drugs.
DePinho and colleagues now believe they know why. His team studied 20 different batches of glioblastoma cells in the lab and found that many growth switches were flipped on at once.
In 19 of the 20 cell lines, three or more were switched on. They tested tumor samples from newly diagnosed cancer patients and got a similar result.
"We found there was a multitude of activated receptor tyrosine kinases," DePinho said in a telephone interview. "When you would extinguish one with a specific targeted agent, the other ones would simply step in."
'BROADLY APPLICABLE'
When they tried Gleevec, known generically as imatinib, it had little effect on the cells. But when they combined it with two other drugs -- Tarceva, known generically as erlotinib, and Pfizer's SU-11274 -- the growth signal was shut down and the cancer cells died.
"It's a very important observation scientifically and it has immediate clinical implications," DePinho said. "This is broadly applicable. This paradigm is true for virtually all solid tumors that we've looked at."
He and colleagues hope to start testing combinations of these targeted therapies in patients.
A person's tumors would be profiled first to determine which signals are active, and then doctors would pick a drug combination that would work best.
DePinho said it would take some time to get these therapies to cancer patients because the drugs used in combination might turn out to be toxic.
He agreed that a cocktail of targeted drugs would be costly. Tarceva -- approved to treat lung and pancreatic cancer -- costs around $3,000 for a 30-day supply.
But he said one of the reasons for the drugs' current high cost is the high failure rate of drug development.
"If we can use science ... to design better clinical trials, the costs will be a lot less," DePinho said.
Source: Reuters
Thu Sep 13, 2007 4:42pm EDT
By Julie Steenhuysen
CHICAGO (Reuters) - Cancer cells often have a way of outsmarting new targeted drug therapies, but U.S. researchers said on Thursday a combination of targeted drugs could shut down a tumor's backup plan, resulting in much more effective treatments.
A number of these so-called targeted cancer drugs -- such as Roche's Tarceva and Novartis' Gleevec -- work by blocking the activity of various protein switches that tell the cell to grow. They are known as receptor tyrosine kinases or RTKs.
"They essentially allow the cell to communicate with the external world to sense growth factors that could maintain the survival of a cancer cell," said Dr. Ronald DePinho of the Dana-Farber Cancer Institute and Harvard Medical School, whose study appears in the journal Science.
These protein switches are on the surface of all cells, and they go haywire in a number of cancers.
Drugs that target a single switch have transformed the treatment of some patients with certain cancers -- for instance, Gleevec and chronic myelogenous leukemia.
But they only work in a small percentage of people. And certain tumors, including the aggressive brain cancer glioblastoma multiforme, respond poorly to such drugs.
DePinho and colleagues now believe they know why. His team studied 20 different batches of glioblastoma cells in the lab and found that many growth switches were flipped on at once.
In 19 of the 20 cell lines, three or more were switched on. They tested tumor samples from newly diagnosed cancer patients and got a similar result.
"We found there was a multitude of activated receptor tyrosine kinases," DePinho said in a telephone interview. "When you would extinguish one with a specific targeted agent, the other ones would simply step in."
'BROADLY APPLICABLE'
When they tried Gleevec, known generically as imatinib, it had little effect on the cells. But when they combined it with two other drugs -- Tarceva, known generically as erlotinib, and Pfizer's SU-11274 -- the growth signal was shut down and the cancer cells died.
"It's a very important observation scientifically and it has immediate clinical implications," DePinho said. "This is broadly applicable. This paradigm is true for virtually all solid tumors that we've looked at."
He and colleagues hope to start testing combinations of these targeted therapies in patients.
A person's tumors would be profiled first to determine which signals are active, and then doctors would pick a drug combination that would work best.
DePinho said it would take some time to get these therapies to cancer patients because the drugs used in combination might turn out to be toxic.
He agreed that a cocktail of targeted drugs would be costly. Tarceva -- approved to treat lung and pancreatic cancer -- costs around $3,000 for a 30-day supply.
But he said one of the reasons for the drugs' current high cost is the high failure rate of drug development.
"If we can use science ... to design better clinical trials, the costs will be a lot less," DePinho said.
Source: Reuters
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