On Friday, the FDA approved a new drug, Onglyza, to treat Type 2 diabetes. Onglyza, a once-daily tablet for adults with Type 2 diabetes, is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a post-market study that will specifically evaluate cardiovascular safety in a higher risk population.

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Delaware.

For more information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174780.htm

Labels: blood sugar, clinical trials, diabetes type 2, FDA, Onglyza

A promising new melanoma liver cancer treatment directs therapy directly at the liver. The procedure, percutaneous hepatic perfusion, or PHP, targets tumors with a dose of chemotherapy 10 times stronger than patients could tolerate intravenously. Doctors use a specially designed system of catheters and filters to apply the cancer-fighting drug only to the liver, reducing the risk of damaging nearby organs and minimizing possible side effects.

The liver is resilient and unlike other organs can tolerate large amounts of chemotherapy. It is one of the largest organs in the body and is essential for general health. The liver removes harmful material from the blood, aids in digestion of food and converts food into nutrients for a healthy and active life. However, cancer can severely impair the liver's ability to perform these crucial functions, and often times when cancer originates in or spreads to the liver, the tumors in the liver can lead to death. When cancer originates in the liver it is called primary liver cancer. Cancer that has spread to the liver from other parts of the body is called secondary, or metastatic, cancer in the liver.

Doctors say PHP is an important step because people who have melanoma liver cancer usually don't live very long. Slightly fewer than 70,000 new cases of this type of cancer will be diagnosed this year in the United States, according to the American Cancer Society. Although it is not the most common of all skin cancers, it is the most deadly. Ocular melanoma is much rarer, with about 2,500 new cases detected each year. The cancer is often lethal if it spreads to the liver, which is the most common site for it to metastasize.

During the procedure, patients receive doses of a drug called melphalan for 30 minutes every four weeks. The treatment takes place in an operating room while the patient is under an anesthetic. The chemo drug is delivered by a catheter that is threaded up a major artery in the patient's groin into the main artery that goes into the liver. Another catheter is placed in the major vein behind the liver, and balloons on the catheter are inflated to direct all the blood flowing out of the liver into a filter outside the body. This filter system removes almost 90 percent of the chemotherapy from the blood, and the blood is then given back to the patient through a catheter placed in a large vein in the neck.

For more information on the clinical trial please see: http://www.livercancertrials.com/

Labels: cancer, clinical trials, Liver, melanoma, percutaneous, php