FDA grants orphan drug status to new ‘Trojan Horse’ like Ewing’s Sarcoma drug
AstraZeneca has announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA. The agreement settles the patent infringement litigation filed by AstraZeneca following Teva’s submission to the United States Food & Drug Administration of an Abbreviated New Drug
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The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation’s unique drug product for children with Ewing’s Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers in private industry and at two universities.
Orphan Drug status allows for recognition of the potential viability of a drug therapy while providing a variety of benefits during the drug approval process. These benefits include waivers of certain FDA fees, the availability of government grants, and FDA attention and assistance during the review process.
This groundbreaking new drug combines two modern technologies: biotechnology and nanotechnology. This incredible technology is analogous to the concept of a Trojan Horse, and is expected to have very far reaching implications for other cancer treatments. The product consists of cell matter that is modified to have the same genetic code as the cancer cells, but that matter is not viable food for the tumor cells. The cell matter is then placed in a nanotechnology formulation which allows the matter to migrate through the body’s own vessels directly to the tumor cells. When the tumor cells uptake the matter, they cannot reproduce, and they die. Key elements of this drug technology are:
- Fewer side effects may be possible
- The drug is directed only at the tumor cell and not at healthy cells
- The product is so small that it migrates right through blood vessels and cell walls
- This technology be applied to other diseases in the future that have a genetic component
The President of the foundation, Barry Sugarman, a 30-year veteran executive and consultant in the pharmaceutical industry, and father of son who has survived Ewing’s Sarcoma, will continue the development of the drug product by raising money from individuals and foundations.
Ewing sarcoma is the second most common type of primary bone cancer seen in children and young adults. Patients with relapsed or refractory Ewing sarcoma have a poor outcome with conventional therapies. Cytarabine decreases the levels of a certain key protein in Ewing sarcoma cells and has demonstrated preclinical activity against Ewing sarcoma cell lines
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Kiadis Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL). One ODD has been granted for diffuse large B-cell lymphoma and the other one for the treatment of follicular lymphoma. Reviroc(TM) is under development
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New data shows that some sarcoma patients are benefiting from treatment with REOLYSIN, developed from a harmless virus called the reovirus that most people are exposed to at some point in their lives. Dr. Monica Mita of the Institute of Drug Development (IDD), the Cancer Therapy and Research Center at the University of Texas Health
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Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.
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A research team from the Massachusetts Institute of Technology (MIT)-Harvard Center for Nanotechnology Excellence has custom-designed nanoparticles that can deliver the anticancer drug cisplatin specifically to prostate cancer cells. The nanoparticles are composed of two different polymers and are decorated with a nucleic acid aptamer that binds to the tumor marker prostate-specific membrane antigen.
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