Jan 6 2010
Dr.
Anthony Tolcher, clinical director for South
Texas Accelerated Research Therapeutics (START) at the START Center
for Cancer Care in San Antonio, announced today that the first patient
has been enrolled in a groundbreaking Phase I clinical trial of a novel
combination anticancer regimen composed of two investigational
compounds: MK-2206 from Merck & Co., Inc. (NYSE:MRK) and AZD6244
(ARRY-886*) from AstraZeneca (NYSE:AZN). In June of this
year, AstraZeneca and Merck made national news when they announced
what they called “a pioneering collaboration” to research a novel
combination anticancer regimen composed of two investigational
compounds, saying that this is the first time that two large
pharmaceutical companies have joined together to evaluate the potential
for combining candidate molecules at such an early stage of development.
START has been chosen as the first Phase I center to test the drug
combination. START conducts the world’s largest Phase I clinical trials
program for oncology.
“This one-of-a-kind study, with two separate
pharmaceutical companies sharing their novel agents for this one
clinical trial performed at START, represents an exciting step forward
for the betterment of cancer research, and most of all, patient care.”
Preclinical evidence indicates that combined administration of these
compounds could enhance their anticancer properties.
The agreement between Merck and AstraZeneca is pioneering in that two
major pharmaceutical companies, each with one component of the
combination regimen in its pipeline, are collaborating at an early stage
in development. Usually, combinations of novel anticancer agents would
only be studied in clinical trials when one component of the regimen is
at a late stage of development or when one compound has received
marketing approval.
Anthony Tolcher, clinical director for START, and principal investigator
for this trial said, “This one-of-a-kind study, with two separate
pharmaceutical companies sharing their novel agents for this one
clinical trial performed at START, represents an exciting step forward
for the betterment of cancer research, and most of all, patient care.”
Background On The Two Anticancer Agents (compiled from
information contained in the companies’ original release on the
collaboration)
Each candidate is designed to inhibit a protein known to be abnormally
activated in human cancers. In preclinical studies, AZD6244 has been
shown to affect MEK (Mitogen-activated protein kinase 1), an important
signal that promotes cancer cell growth and survival. AZD6244 has
completed Phase I evaluation, demonstrating proof of mechanism, and
several Phase II monotherapy studies, which showed evidence of clinical
activity. It is currently in Phase II clinical trials in a range of
tumor types. Merck’s MK-2206 has demonstrated an effect on AKT (a
component of the phosphatidylinositol-3 kinase pathway), an important
signal promoting cancer cell survival.
Advances in cancer research have led to a new generation of drugs
designed to precisely target features specific to cancer cells while
minimizing the effect on healthy cells. Several of these drugs provide
patient benefit as monotherapy, but increasingly the ability of cancer
cells to adapt and develop resistance has become apparent. Research
suggests that combination therapies that include drugs with different
mechanisms of action impacting cancer cells in multiple ways may provide
an improved anticancer benefit and decrease the risk of relapse.
Molecular profiling of human solid tumors has shown that both the MEK
and AKT pathways are frequently abnormally activated. Preclinical
studies have suggested that simultaneously inhibiting both of these
pathways may have synergistic effects on tumor cell growth.
http://www.startthecure.com/