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Senior Citizen Health & Medicine
New Type Drug Found Effective in Innovative Attack
on Melanoma Cancer
New drug with chemotherapy more than doubled the
time patients survived without progression of their cancer
Sept. 26, 2007 - An experimental drug that attacks
cancer in an entirely new way has shown promise in treating advanced
melanoma, delaying progression of the disease and prolonging the lives
of patients. Half of all deaths from the skin cancer melanoma in
developed countries are among older men those over age 50.
New research presented today at the European Cancer
Conference (ECCO 14) in Barcelona, Spain, found that giving the new drug
in addition to chemotherapy more than doubled the amount of time
patients survived without progression of their cancer.
The study, according to Dr Anthony Williams, vice
president of clinical research at Synta Pharmaceuticals Corp. in
Lexington, Massachusetts, USA, included 81 patients with metastatic
melanoma. Of those, 28 received treatment with the chemotherapy drug
paclitaxel alone and 53 received paclitaxel plus the new drug, STA-4783.
"The median progression free survival was 1.8
months in the group who got chemotherapy alone, but 3.7 months in the
group who got the combination," Williams said. "This doubling in
progression free survival is impressive for this cancer, and the result
was achieved without substantial additional toxicity."
He added: "Progression-free survival was linked to
improvements in overall survival. Patients on the experimental
combination survived on average for 12 months after being diagnosed,
while those getting only paclitaxel survived on average 7.8 months. This
is the first time an improvement in survival has been seen in a
randomised, double-blind, multi-centre controlled trial for metastatic
melanoma."
The drug is the first in a new class called
oxidative stress inducers. It works by increasing the amount of reactive
oxygen species (ROS), such as hydrogen peroxide and superoxide, in
cells. When the level exceeds the antioxidant capacity of cells, the
cells are in a state of oxidative stress.
All cells have some low level of ROS, but cancer
cells naturally operate with a higher level of ROS and oxidative stress
relative to normal cells. However, too much oxidative stress for too
long results in cell death. STA-4783 kills only tumour cells because the
additional stress introduced pushes cancer cells, but not healthy cells,
over the critical threshold.
Melanoma is one of several cancer types that are
known to operate at a higher level of oxidative stress.
The concept of cancer cells operating at a higher
level of oxidative stress than normal cells has been around for many
years. However, it is only recently becoming a greater focus of
attention in the oncology field.
Metastatic melanoma, where the skin cancer has
spread to other parts of the body, is difficult to treat. Current
therapies either have limited power or are highly toxic. The average
survival of patients diagnosed with advanced melanoma is about six
months.
The study also indicated that STA-4783 might boost
the efficiency of chemotherapy drugs that induce cell death, or
apoptosis, because it appears to lower the hurdle for activating that
process, Williams said.
"These results are encouraging not only because of
the findings in themselves but also because there are so few treatment
options for patients. We believe STA-4783 has the potential to improve
survival with a manageable side effect profile," he said.
"We also believe there is nothing unique about
metastatic melanoma and that oxidative stress has the potential to be an
entirely new class of cancer treatment that could have applications in
other types of cancer," Williams added.
A larger study of STA-4783 in melanoma patients
across Europe is now under way to further investigate the drug's
potential. Synta, the drug's developer, funded the study presented at
ECCO.
The American Cancer Society
says 62,190 new cases of melanoma are expected to be diagnosed in the
U.S. this year, and about 7,910 will die from this cancer. The death
rate has increased 50% since the 1970s.
Editors Notes:
About STA-4783 (Synta Pharmaceuticals)
STA-4783 is a novel, injectable, drug candidate
that kills cancer cells by elevating oxidative stress levels beyond a
breaking point, triggering programmed cell death. In preclinical models
STA-4783 showed potent killing of a broad range of cancer cell types at
high doses, and an ability to strongly enhance the efficacy of certain
chemotherapy agents, with minimal additional toxicity, at moderate
doses. In a recent 21-center, double-blind, randomized, controlled Phase
2b clinical trial in 81 patients with metastatic melanoma, STA-4783 in
combination with paclitaxel met the primary endpoint - doubling the
median time patients survived without their disease progressing -
compared to paclitaxel alone (p=0.035). STA-4783 is now entering a
pivotal, confirmatory Phase 3 clinical trial in melanoma. Phase 2 trials
in other indications, and in combination with other agents, are planned.
About Metastatic Melanoma
Melanoma, the most deadly form of skin cancer,
arises from melanocytes, the pigment-producing cells of the skin.
According to the American Cancer Society, melanoma accounts for
approximately five percent of all skin cancers but causes about 75% of
all skin cancer-related deaths. An estimated 60,000 people will be
diagnosed and nearly 8,200 people will die from melanoma this year in
the U.S. alone. If diagnosed and surgically removed while localized in
the outermost skin layer, melanoma is potentially curable; however, for
patients with metastatic disease the prognosis is poor with limited
available treatments and an expected survival of only six to nine
months. The incidence of melanoma has increased more rapidly than any
other cancer during the past ten years. The FDA has not approved a
novel, small molecule drug for the treatment of metastatic melanoma in
over 30 years.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is a
biopharmaceutical company focused on discovering, developing, and
commercializing small molecule drugs to extend and enhance the lives of
patients with severe medical conditions, including cancer and chronic
inflammatory diseases. Synta has a unique chemical compound library, an
integrated discovery engine, and a diverse pipeline of clinical- and
preclinical-stage drug candidates with distinct mechanisms of action and
novel chemical structures. All Synta drug candidates were discovered and
developed internally.
For more information, please see
www.syntapharma.com.
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