FDA Expands Use of Approved Breast Cancer Drug

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth. In HER2-positive breast cancer, stimulation of the HER2 receptor contributes to cancer cell growth. Breast cancer is the second leading cause of death among women. More than 192,000 women will be diagnosed with breast cancer this year.

"This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option. This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells' ability to grow or spread," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, in the FDA's Center for Drug Evaluation and Research.

Women with HER2-positive disease receiving the Tykerb plus Femara combination more than doubled the time they lived without the cancer progressing compared with those receiving Femara alone (35 weeks vs. 13 weeks). Women in the company sponsored study were randomized to receive Tykerb plus Femara or Femara alone. It is too early to determine whether an improvement in overall survival will be observed in the clinical trial.

Tykerb works by depriving tumor cells of signals needed to grow. Tykerb enters the cell and blocks the function of the HER2 protein.

Tykerb was initially approved in combination with a chemotherapy drug, Xeloda (capecitabine) in 2007. This combination was used to treat women with advanced breast cancer tumors with the HER2 protein who had received prior treatment with chemotherapy drugs, including an anthracycline and a taxane, and Herceptin (trastuzumab), an anti-cancer antibody used to treat HER2-positive advanced breast cancer.

Safety information from this study was consistent with previous Tykerb clinical studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhea, rash, nausea and fatigue. Treatment with Tykerb also has been associated with decreases in heart function, liver damage, and lung tissue inflammation. Fetal harm may occur if used to treat advanced breast cancer in pregnant women. Patients should talk to their health care provider about the potential side effects, drug interactions, and other medical conditions.

Tykerb is marketed by Collegeville, Pa.-based GlaxoSmithKline.

Femara is marketed by Lebanon, Pa.-based Novartis AG.

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National Advocacy Organization Representing Home Oxygen Patients Praises Introduction of Medicare Home Oxygen Therapy Act

/PRNewswire/ -- Providing a voice to home oxygen patients nationwide, including patients with chronic obstructive pulmonary disease (COPD) and other lung diseases, the National Emphysema/COPD Association (NECA) today called the Medicare Home Oxygen Therapy Act of 2009 (H.R. 3220) a patient-focused piece of legislation that protects the best interests of the nation's 1.5 million beneficiaries and promotes quality home oxygen care.

"Home oxygen provides patients with improved quality of life by allowing them to receive oxygen safely in their home, maintain activities of daily living and remain active in their communities. We appreciate that this legislation recognizes the important patient services that oxygen users need to feel secure in their care," said Barbara Rogers, President of NECA. "As a home oxygen user, I fully understand the critical importance of the services that accompany home oxygen care. NECA strongly supports the Medicare Home Oxygen Therapy Act and encourages Congress to adopt this legislation into healthcare reform."

The Medicare Home Oxygen Therapy Act of 2009 establishes a standard set of patient services that all oxygen providers must deliver to beneficiaries, including routine patient evaluations, patient monitoring, equipment training and maintenance and emergency services, all of which play a crucial role in ensuring oxygen users are receiving the medically appropriate level of oxygen that meets their needs and allows them to live safely and comfortably. By ensuring access to these services and important patient safeguards, this legislation recognizes that home oxygen is much more than a piece of oxygen equipment; it is a healthcare service that provides life-supporting oxygen, which enables patients to breathe.

"Without home oxygen, many patients would be housebound or in a long term care facility, so in a sense, home oxygen gives people their lives back by allowing them to maintain their independence," Rogers said. "The average oxygen user in our community is elderly, lives alone, has multiple co-morbidities and fully depends on their home oxygen services to avoid revolving emergency room visits and inpatient hospitalizations associated with their COPD or other lung condition. Legislation that strengthens our benefit by assuring much-needed patient services and education is good for all home oxygen patients, across the board."

Across the United States, more than 12 million Americans have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and other degenerative lung conditions. COPD is currently the fourth leading cause of death and the second leading cause of disability in the United States, and is on the rise. According to the U.S. Department of Health and Human Services' National Heart, Lung and Blood Institute, approximately 12 million additional adults are thought to have undiagnosed impaired lung function, which indicates COPD is grossly under diagnosed. As a progressive, incurable disease that causes irreversible loss of lung function, COPD can severely confine patients by limiting their daily living activities. Home oxygen therapy is one of the only effective treatments for these patients when properly used.

"An oxygen benefit that puts the needs of patients first is what our community needs, which is why we support this bill," added Rogers.

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Metastatic Colon Cancer: In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled 5-Yr Survival Rate‏

The Burzynski Research Institute, Inc.(BRI) is pleased to announce the results of a randomized Phase II clinical study of antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of hepatic metastases. The study was performed at the Kurume University School of Medicine (Japan) in the Department of Surgery. A report of the study results is currently in press.

The study population consisted of 65 colon cancer patients who had undergone curative resection of hepatic metastases and were randomized to 1) intrahepatic infusion of 5-FU (33 patients), or 2) intrahepatic infusion of 5-FU plus IV ANP therapy (32 patients). ANP therapy consisted of a) 50-100 g IV infusion of Antineoplaston A10 given daily for seven days following hepatic resection and b) 10 g of oral Antineoplaston AS2-1 given daily for one year.

There was a significant difference in overall survival between the two groups: with the five-year survival rate in the 5-FU plus ANP therapy arm being 62% versus 32% in the 5FU-only arm. The mode of recurrence was also different in the two study arms. In the 5FU-only arm, recurrences affected multiple organs in 69%, while in the 5-FU plus ANP therapy arm, recurrences affected multiple organs in only 34%, which provided for a higher complete second resection rate in the 5-FU plus ANP therapy arm (61% versus 35%).

Dr. Stanislaw R. Burzynski, Chairman and CEO of BRI stated, "We are very pleased with the results of this study, and thankful to our Japanese colleagues. The results indicate that ANP therapy may find application not only in the treatment of brain tumors as reported previously, but also in the more common colorectal cancer."

Kurume University is among the oldest and most successful medical universities in Japan. Its Department of Surgery has a strong interest in the development of successful treatments for colorectal and liver cancers.

Burzynski Research Institute, Inc. (BRI) is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are now focused on basic research and Phase III clinical trials.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. Burzynski Research Institute, Inc. cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Information contained in forward-looking statements is based on current expectations and is subject to change, and future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to BRI's ability to obtain regulatory approval for Antineoplastons A10 and AS2-1, risks associated with BRI's ability to raise sufficient capital from the development of its technology towards commercialization, and other risks described in BRI's periodic reports filed with the Securities and Exchange Commission. BRI does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein.

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