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Drug-clinical research updates

12/29/2009

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Merck begins late-stage study of potential lung cancer vaccine.
Oncothyreon Inc. Reported that its partner Merck KGaA started a late-stage study on Stimuvax as a potential lung cancer treatment." Oncothyreon "said the study is expected to enroll 420 patients with inoperable, stage 3 lung cancer in China, Singapore, South Korea, and Taiwan," and the "key goal is overall patient survival." Stimuvax "is also currently being studied as a potential breast cancer treatment." Additionally,  Stimuvax is a vaccine, and the trial aims to target patients with advanced non-small cell lung cancer.

High dose of fulvestrant may reduce risk of breast cancer progression.
A high dose of its drug Faslodex [fulvestrant] reduced the risk of breast cancer progressing by 20 percent in patients during a late-stage study reports a study from Astra Zeneca. The study "compared a 500-milligram dose versus a currently approved 250-milligram dose in postmenopausal women with advanced breast cancer" and found that the "higher dose pushed back to 6.5 months from 5.5 months the amount of time it took for breast cancer to progress in patients."

Denosumab may cut risk of skeletal related events in patients with advanced breast cancer.
According to results of phase III trials presented at the San Antonio Breast Cancer Symposium, Amgen, Inc.'s bone drug denosumab cut the risk of multiple skeletal related events, such as fracture, radiation, and surgery on bones, or spinal cord compression, in patients with advanced breast cancer by 23 percent compared to Novartis AG's Zometa (zoledronic acid). Researchers also found that the drug delayed the first occurrence of these events. The FDA delayed approval of denosumab for osteoporosis in postmenopausal women, seeking additional safety data.

Varicella vaccine may offer shingles protection.
According to data in the Pediatric Infectious Disease Journal, Investigators at the Kaiser Permanente Department of Research "Children who are vaccinated against chicken pox may also have increased protection against shingles based on health records of 172,163 children in southern California who were vaccinated with the varicella (chicken pox) vaccine between 2002 and 2008." They noted that "over an average of 2.5 years after receiving the chicken pox vaccine, only 122 cases of shingles (Herpes zoster) occurred among the children, an estimated incidence of one case per 3,700 children per year."  

A lower rate than that previously recorded, as prior to vaccination becoming readily available, the incidence of H. zoster infection in children aged five to nine years and in those aged 14 years or younger was reported to be 30 and 46 cases per 100,000 person years, respectively." And, "of the children with H. zoster, 0.7%, 11.1%, 8.3%, and 2.1% had lymphoid leukemia, had asthma with three or more acute exacerbations, had developmental disorders, or had psychological or mental disorders, respectively," leading the authors to conclude that "despite the small numbers, the roles of delayed vaccination, severe asthma, and development disorders warrant further investigation."

FDA approves extended release quetiapine as add-on treatment for MDD.
Astra Zeneca PLC announced that the FDA approved its schizophrenia medication Seroquel XR [quetiapine] "as an add-on treatment for major depressive disorder (MDD)." But, the drugmaker said that the FDA "has asked for more information before allowing the drug's use as a single agent to treat [MDD]." The AP noted that "Seroquel XR is an extended-release version of AstraZeneca's schizophrenia medication Seroquel," which "is already approved for bipolar disorder and schizophrenia."  

Seroquel is an atypical antipsychotic whose side effects include tardive dyskinesia and weight gain. AstraZeneca said that the FDA approved adding Seroquel XR to current depression treatment in patients only if that treatment is not working properly. The pharmaceutical company did not disclose, however, what further information the agency is looking for with regard to Seroquel XR as a primary treatment for depression.

Novel form of trastuzumab may improve outcomes in metastatic breast cancer. According to research presented at the San Antonio Breast Cancer Symposium, "a new targeted cancer drug has been shown to shrink tumors in women with metastatic breast cancer after an average of seven other drugs, including Herceptin [trastuzumab], failed." The experimental drug, T-DM1, "combines Herceptin with a potent chemotherapy drug" that allows Herceptin to bind to and block "the HER2 receptor that appears on the surface of some breast cancer cells." This mechanism delivers "the cancer-killing agent directly" to the cancer cells.  

In a study of "110 women assigned to open-label treatment with single agent trastuzumab-DM1," researchers found that "median progression-free survival was 7.3 months" with T-DM1. Meanwhile, "the objective response rate was 32.7 percent in women whose tumors had progressed after treatment with an anthracycline, taxane, capecitabine (Xeloda), trastuzumab, and lapatinib (Tykerb)."

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