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Pancreatic cancer drug TNFerade by GenVec to get speedy approval in US

Wednesday, November 4, 2009, 20:40 This news item was posted in Clinical Trials category and has 0 Comments so far.

TNFerade, an investigational drug against pancreatic cancer, has been awarded Orphan Drug status providing potential financial and regulatory incentives by the U.S. Food and Drug Administration, its maker GenVec announced in a press statement.

TNFerade, which has not yet been approved for use, is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha).

TNF alpha is an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors.

TNFerade stimulates the production of TNF-alpha in the tumor.

A Phase III trial comparing TNFerade along with standard of care therapy (defined as infusion 5-FU and radiation therapy, followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) versus standard of care therapy in the treatment of locally advanced, unresectable pancreatic cancer is currently underway.

Patients will be randomly selected (2:1) to one of the two treatment groups.

Named PACT Study, phase II/III research study tested the safety and effectiveness of an investigational drug called TNFerade in combination with the standard of care therapy against locally advanced pancreatic cancer.

Pancreatic Cancer Clinical Trial with TNFerade (PACT) included approximately 330 patients who have pancreatic cancer that cannot be removed with surgery. Each patient received 5 weeks of treatment and 12 months of follow-up, followed by annual contacts.

Overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec’s ongoing Phase III  were presented at the 45th American Society of Clinical Oncology Annual Meeting in Orlando, FL, in June.

TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer.

TNFerade has been granted Fast Track product designation by the US Food and Drug Administration or its proposed use in the treatment of locally advanced pancreatic cancer.

The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year.

Orphan drug designation provides potential financial and regulatory incentives including study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval.

“Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits,” stated Dr Paul Fischer,GenVec’s President and CEO.

What is pancreatic cancer?

In pacreatic cancer  islet cells which produces insulin can become cancerous and form what is known as an endocrinal tumor. This form of pancreatic cancer is rare.  The vast majority of pancreatic cancer cases occur when the cells that line the pancreatic ducts begin growing out of control.  This type of tumor is known as an exocrinal tumor, or adenocarcinoma of the pancreas.

Pancreatic cancer tends to be very aggressive and spreads rapidly over a relatively short period.  Early diagnosis and time to appropriate treatment is crucial to the clinical outcome of the pancreatic cancer patient.  The progress of pancreatic cancer can be roughly broken down into three stages—localized, locally advanced unresectable (inoperable) pancreatic cancer, and metastatic disease.

Less than about 20% of pancreatic cancer cases are detected when the tumor is still localized.  This means that the tumor is confined to the pancreas, without involving the blood vessels near the pancreas known as the mesenteric bundle.

Localized pancreatic cancer can be surgically removed. However, because patients often do not exhibit clear symptoms during this stage of the disease, the cancer is often not caught early.

Approximately 30% of pancreatic cancers are detected when the tumor has become locally advanced.  At this stage, there is involvement of the mesenteric bundle of blood vessels, and/or metastases to nearby lymph nodes.

The balance of pancreatic cancer cases are, unfortunately, detected when there are clear signs that the cancer has spread to other nearby and/or distant organs in the body.

Treatment for pancreatic cancer may include surgery, radiation therapy, chemotherapy, biological therapies and/or complementary and alternative therapies.  Pancreatic cancer patients may receive one or more of these treatments.

Over 37,000 men and women in the United States will be diagnosed with pancreatic cancer this year, and, unfortunately, more than 34,000 will die,T according to the American Cancer Society (ACS) estimates.

Pancreatic cancer is the fourth most frequent cause of cancer deaths in the US.

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