Serious
side effects discovered years later
Serious adverse
drug reactions are often discovered and reported many years after a
cancer drug has been approved by the U.S. Food and Drug
Administration, new research shows. This suggests a need for better
detection and reporting of such events. “In one case, a package
insert was not revised to reflect a serious reaction until 36 years
after the drug was approved," said senior author Dr. Charles L.
Bennett of Northwestern University in Chicago. Bennett's team
identified 25 serious adverse drug reactions that occurred with 22
cancer drugs and were reported between 2000 and 2002. The reactions
resulted in death or severe organ failure, they report in the
October 15th issue of the Journal of Clinical Oncology. About half
of the serious events were reported at least 5 years after FDA
approval. The message for clinicians and patients is to report
adverse events no matter how small they seem to be, Bennett said.
(November 2003)
ASH
abstracts now available online
Each December,
the American Society of Hematology’s annual meeting provides
hematologists from around the world a forum for discussing critical
issues in hematology. Nearly 20,000 clinicians, scientists and
others attend the four-day meeting, which consists of an educational
program and cutting-edge scientific sessions. Oral and poster
presentations, which are chosen by peer-reviewers from abstracts
submitted prior to the annual meeting, are featured at the annual
meeting and contain the latest and most exciting developments in
scientific research. Plenary symposia and named lectures on
specialized areas of hematology are also presented throughout the
meeting program. During the annual meeting, attendees can also visit
the state-of-the-art exposition, which features exhibits from
pharmaceutical companies, medical suppliers, clinical diagnostic and
research-based companies, publishers, and non-profit organizations.
This year’s meeting runs from Dec. 6-9 in San Diego, Calif. Visit
the Web site to read
more about the conference and get access to the latest research
abstracts, including many about CML.
(November 2003)
Gleevec
researcher speaks at conference
Alex Matter of
Novartis Pharma AG in Basel, Switzerland, will offer the second
keynote speech, "The Reality of Making Cancer Drugs,” at the
AACR-NCI-EORTC
International Conference. The conference, “Molecular Targets and
Cancer Therapeutics: Discovery, Biology, and Clinical Applications,”
runs from November 17 to 21 at Hynes Center in Boston, Mass. Matter
and his team of 300 scientists were among the leaders in the
discovery of Gleevec, the first oral drug shown to be effective in
the treatment of chronic myeloid leukemia (CML). Each year, the
American Association for Cancer Research (AACR), jointly with the
National Cancer Institute (NCI) and the European Organisation for
Research and Treatment of Cancer (EORTC), brings together scientists
and other professionals from around the world seeking to share the
latest information in this field, otherwise known as molecular
targets of cancer. More than 2,500 scientists and clinicians,
including top executives and researchers from more than 300
pharmaceutical and biotech companies, will attend the conference to
discuss such topics as the circadian rhythm of cells, turning tumors
against themselves, and improving radiotherapy.
(November 2003)
Moshe
Talpaz joins Callisto board
Dr. Moshe Talpaz,
chairman of the Department of Bioimmunotherapy of The University of
Texas M. D. Anderson Cancer Center, has become a member of the
Scientific Advisory Board of Callisto Pharmaceuticals Inc. to help
advance multiple myeloma research. Talpaz, well known for his role
in the clinical development of Gleevec, is an
internationally-recognized authority on leukemia and blood cancers.
He continues to be involved in the clinical development of numerous
cancer drugs and has been a pioneer in developing currently accepted
treatment protocols especially in the leukemia area. Callisto is a
biopharmaceutical company primarily focused on the development of
drugs to treat multiple myeloma, other cancers and osteolytic bone
disease.
(October 2003)
New
medication reduces chemo nausea
Nausea and
vomiting from chemotherapy can be reduced by nearly 50 percent when
cancer patients are given a new drug along with existing medicines
to treat those side effects, according to a recent study published
in the Journal of Clinical Oncology. In an international clinical
trial of 520 patients with respiratory cancers, 26 percent of those
who received the drug aprepitant along with ondansetron and
dexamethasone, the standard anti-nausea and anti-vomiting
treatments, reported those side effects following chemotherapy.
Patients who took a placebo with the standard drugs reported nausea
and vomiting 48 percent of the time. The same drug can also help
patients who must undergo several rounds of chemotherapy, according
to a separate 164-person study conducted in the Netherlands. That
study found aprepitant protected against nausea and vomiting over
repeated chemotherapy treatments when the side effects tend to
worsen and existing drugs become less effective.
(October 2003)
And second
prize is?
For the last nine
years, Leukemia Society supporters in the Upstate New York/Vermont
Chapter have raised funds to win an unusual prize. Those who raise
$200 or more get to slide into a large vat of & red gelatin. "Kids
love the event," said Maureen Thornton, chapter executive director,
"but you'd be surprised how many adults participate. This year, the
chapter raised more than $22,000 with slide events in Poughkeepsie
and Albany, N.Y. Society staffer Andi Ciminello wondered how her
son, Adam, an ALL patient, would raise the money. "But he went to
school one day and asked friends and teachers to contribute, and
raised the money in no time flat," she said.
(September 2003)
Cancer
Survivors Day set for June 1
On Sunday, June
1, 2003, over 700 communities throughout North America and elsewhere
will hold celebrations of life as part of the 16th annual National
Cancer Survivors Day (NCSD). On this day, the lives of all people
around the world who are living with a history of cancer are
celebrated, and attention is focused on the issues of cancer
survivorship. NCSD is also a time to acknowledge those professionals
dedicated to cancer treatment, research and support services. A
"survivor" is anyone living with a history of cancer, from the
moment of diagnosis through the remainder of life. NCSD is the
world's largest and fastest-growing annual cancer survivor event.
The nonprofit National Cancer Survivors Day Foundation supports
hundreds of local hospitals, support groups, and other
cancer-related organizations that hold National Cancer Survivors Day
events by providing guidance, education and networking. In the
beginning, cancer survivor Richard Bloch (co-founder of H&R Block)
and his wife, Annette, held their first Cancer Survivor Rally in
Kansas City. The idea soon caught on and has come to be known as
National Cancer Survivors Day. Visit the
NCSD Web site for more
information.
(May 2003)
Leukemia
Society offers patient Web pages
The Leukemia &
Lymphoma Society has launched Connect2Cure, a new Web site that
makes it easy for users to keep friends and family informed about
their society fundraising and volunteer activities via personal
pages and regular email updates. The system — the 21st century
version of the Society's Friends & Neighbors drives — features tools
to post personal photos and copy as well as donation links to help
the society battle leukemia, Hodgkin and non-Hodgkin lymphoma and
myeloma. "This fun and easy service is a place where people who have
joined together in the battle against blood cancers can share their
stories and raise money for the fight," explained Frank Bock, Ph.D.,
senior program director, Internet. For more information, visit the
Connect2cure Web site.
(May 2003)
Phase 2 CML
vaccine trial begins
Antigenics Inc.
says it has begun a phase II trial of its AG-858 personalized
therapeutic vaccine in combination with Novartis AG's Gleevec
(imatinib mesylate) as a treatment for chronic myelogenous leukemia
(CML). Investigators plan to recruit up to 120 patients who are
currently receiving Gleevec treatment but have not achieved a
complete clinical response. In an earlier trial that treated five
people with AG-858 and Gleevec, all five demonstrated objective
clinical responses, according to Antigenics. Four of the patients
were unresponsive to treatment with Gleevec alone. Antigenics said
two of the five patients in that study experienced complete
molecular responses, which is believed to be achieved by fewer than
10% of patients treated with Gleevec alone. Antigenics Chief Medical
Officer Dr. Jonathan Lewis said enrollment in the new trial should
be completed by the second half of this year, with interim results
likely to be presented by the first half of 2004. AG-858 is a
therapeutic vaccine created by isolating heat shock proteins from
cancer patients. Antigenics can prepare AG-858 within two to three
days after isolating HSP70 from a patient's blood cells. The heat
shock protein acts as a magnet and attracts antigens and peptides
unique to the person's cancer, and then destroys the cancer cells.
While heat shock proteins are found in normal cells as well as
cancer cells, the DNA cargo they carry is different. By isolating
the heat shock proteins from cancer cells, Antigenics can create a
precise vaccine to attack the particular cancer.
(April 2003)
FDA grants
"orphan" status to new CML drug
Celmed
BioSciences, a subsidiary of Theratechnologies that is engaged in
the field of cell therapy, says the U.S. Food and Drug
Administration has granted orphan drug designation for Theralux when
used to treat patients with chronic myeloid leukemia. Theralux is
Celmed's photodynamic therapy (PDT) technology being developed to
destroy cancer cells in bone marrow or blood outside the body (ex
vivo), using a proprietary drug, TH9402, which selectively kills
cancer cells when exposed to light. Orphan drug designation is
granted to products that have the potential to treat
life-threatening diseases that affect fewer than 200,000 patients in
the United States. It gives the designated drug or biological
product seven years of market exclusivity in the United States and
also provides access to potential grant funding for clinical
research and other cost savings. Celmed is already conducting a
Canadian pilot clinical study using Theralux in CML patients and
expects to announce results of this trial sometime this year. For
more information, visit the Company's website.
(April 2003)
Global
cancer rates on the rise
Global rates of
cancer could rise 50 percent to 15 million new cases a year by 2020,
the World Cancer Report says. But healthy lifestyles and public
health action by governments and health practitioners could stem
this trend and prevent as many as one-third of cancers worldwide,
the report says. Once considered a largely Western disease, cancer
now affects and kills more people in the developing world than in
industrialized nations. In many countries, it accounts for more than
a quarter of all deaths. In 2000, 5.3 million men and 4.7 million
women developed a malignant tumor and altogether 6.2 million died
from the disease. The World Cancer Report is a concise manual
describing the global burden, the causes of cancer, major types of
malignancies, early detection and treatment. The 351-page global
report is issued by International Agency for Research on Cancer
(IARC), which is part of the World Health Organization (WHO). A
complete list of cancer rates by countries can be found at the
IARC Web site.
(April 2003)
New CML
treatments on horizon
Human trials of a
new CML drug may begin this spring. Details about the drug haven’t
been released. But the drug, rumored to be made by Bristol Myers
Squib, is expected to be a new type of kinase inhibitor that
selectively inhibits BCR-ABL, as imatinib mesylate (IM, Gleevec)
does, as well as oncogenic SRC proteins. Trials are expected to
initially be launched at M.D. Anderson Cancer Center in Houston,
Texas, and UCLA’s Jonsson Cancer Center in Los Angeles, California.
One drug that has been reported on in research articles that’s both
a BCR-ABL and an SRC inhibitor is PD180970. Another is SKI-606,
developed by Wyeth. SKI-606
inhibits phosphorylation of cellular proteins, including STAT5, at
concentrations that inhibit proliferation in CML cells. The phase I
trials are expected to be open only to people for whom IM has not
worked or who are unable to take it. Stay tuned for more details as
they come in, as well as updates on ongoing trials with experimental
vaccine therapy.
(March 2003)
Simple test
rates accuracy of cancer sites
Cancer patients
looking for herbs, vitamins or other unconventional therapies on the
Internet have a new tool to help them avoid quack cures and bad
medical information. Web users can rate a site with four simple
yes-or-no questions designed by the authors of The Internet for
Medical Information About Cancer: Help or Hindrance? Each yes answer
is considered a red flag, a warning that the Web site is likely to
have vague or scientifically inaccurate information. The questions
are:
Is online purchasing permitted?
Are patient testimonials available?
Is the treatment described as a cancer cure?
Is the treatment described as “having no side effects”?
While sites with no red flags often provided some scientifically
accurate information, those with red flags did not. Instead, they
included large amounts of vague and unsubstantiated information.
(March 2003)
UCLA
program studies environmental causes of cancer
A new program at
UCLA’s Jonsson Cancer
Center and the School of Public Health will seek to discover
subtle variations in the human genetic blueprint that predispose
some individuals to develop cancer after contact with environmental
pollutants. The program will explore why some people exposed to
second-hand cigarette smoke develop lung cancer, while others don’t,
for instance. Bringing together top environmental researchers and
molecular biologists at UCLA, the program hopes to shed new light on
how pollutants interact with genetics to cause a variety of cancers.
The Ann Fitzpatrick Alper Program in Environmental Genomics will be
headed by Dr. Robert H. Schiestl, UCLA professor of pathology,
environmental health and radiation oncology.
(March 2003)
FDA
approves new anti-nausea med for chemo
The U.S. Food and
Drug Administration has approved Merck & Co.'s drug Emend
(aprepitant) for the prevention of acute and delayed nausea and
vomiting caused by initial and repeat chemotherapy. Emend, which was
approved for use in combination with two other antiemetics, is the
first product to be cleared in the U.S. for prevention of the
delayed nausea and vomiting that can occur more than 24 hours after
treatment with drugs such as high-dose cisplatin, the FDA said.
Emend works by blocking NK1 receptors in the brain. However, the
agency cautioned that Emend can interact with certain medications,
including some chemotherapy drugs and anticoagulants, and can reduce
the effectiveness of birth control pills.
(March 2003)
|
