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Abraxane gets orphan drug desig for pancreatic cancer, melanoma: Abraxis Bio

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Tuesday, November 10, 2009, 11:56 This news item was posted in Clinical Trials category and has 0 Comments so far.

Abraxane delivers higher doses of anti-cancer drug paclitaxel using nano delivery


Abraxane, a breast cancer drug by Abraxis Biosciences, has been granted orphan drug designation to treat pancreatic cancer as well as stage IIB-IV melanoma by US Food and Drug Administration.

Abraxane (paclitaxel protein-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience’s proprietary nab technology platform.

US FDA granted orphan-drug designation for Abraxane for the treatment of pancreatic cancer in September 2009 and stage IIb to IV melanoma in October 2009.

Orphan drug designation is granted by US FDA to novel drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.

Orphan drug designation provides the drug developer with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication.

Abraxis nab protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein.

Abraxane can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel as it becomes more side-effect free by wrapping the albumin around the active drug paclitaxel.

Abraxane is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic cancer.

“As we advance our pivotal clinical trials of Abraxane in pancreatic cancer and melanoma, we look forward to the potential of bringing a new treatment option to patients with these difficult to treat cancers,” said Lonnie Moulder, president and chief executive officer.

Enrollment is ongoing in a Phase III study that will evaluate Abraxane plus gemcitabine versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer.

A phase III registration study comparing Abraxane to dacarbazine (or DTIC) in the treatment of stage IV chemotherapy naïve melanoma patients is actively enrolling.

Pancreatic cancer and metastatic melanoma can be particularly hard to treat cancers.

More than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States, this year. Many patients are diagnosed with pancreatic cancer after their disease has spread and more than 35,000 people annually will die from the disease.

Melanoma is an aggressive form of skin cancer that affects more than 68,000 people in  US each year. Melanoma is the leading cause of skin cancer death and the current five-year survival rate for patients with advanced stage melanoma is 25 percent.

Abraxane (Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) was approved by US FDA for  (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

What is pancreatic cancer?

n 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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