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First Patient Enrolled in Phase I Clinical Trial of Landmark AstraZeneca, Merck & Co. Novel Combination Anticancer Regimen

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.

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.

Patients wishing more information about the study should call Tracy Dufresne, patient referral coordinator for START at 210-593-5265.

About South Texas Accelerated Research Therapeutics (START)

South Texas Accelerated Research Therapeutics (START) is located in San Antonio, at the START Center for Cancer Care. The mission of START is to accelerate the development of new anticancer drugs with the purpose of improving quality of life and survival for patients with cancer. START consists of a team of highly trained physicians and staff with extensive experience in Phase I clinical trials research. In 2008, START expanded globally with the launch of START Madrid representing the first step in our goal to keep the development of anticancer agents operating 24 hours a day. Because of the work of scientists like those at START, real progress is being made against cancer. Through the hard work of these physicians and the continuing advances in technology we are able to improve the tools to understand, detect, and diagnose cancer. Today, people with cancer are living longer than ever before with a better quality of life.


For South Texas Accelerated Research Therapeutics
Kelly Morris, 210-843-9900

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