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Istari Oncology Announces FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma


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Istari Oncology Announces FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma
Istari Oncology Announces FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma
Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PVSRIPO for the treatment of advanced melanoma (stage IIB-IV). PVSRIPO is a novel viral immunotherapy, based on the Sabin type 1 polio vaccine, that activates a patients innate and adaptive immune system to facilitate an anti-tumor response and establish long-term immunologic memory to help prevent the cancers return. ....

North Carolina , United States , Duke University Medical Center , Duke University , Research Triangle Park , Garrett Nichols , Matthias Gromeier , Darell Bigner , Matt Stober , Emily Brice , Christina Tartaglia , Society For Immunotherapy Of Cancer , National Cancer Institute , Istari Oncology Inc , Istari Oncology Medical Affairs Contact , Drug Administration , Office Of Orphan Products Development , Istari Oncology , Chief Executive Officer , Chief Medical Officer , Orphan Products Development , Breakthrough Therapy Designation , Orphan Status , Statistics Review , National Cancer , Oncology Medical Affairs Contact ,

Recurrent GBM brain tumors with few mutations respond best to immunotherapy


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DURHAM, N.C. - Glioblastoma brain tumors are especially perplexing. Inevitably lethal, the tumors occasionally respond to new immunotherapies after they ve grown back, enabling up to 20% of patients to live well beyond predicted survival times.
What causes this effect has long been the pursuit of researchers hoping to harness immunotherapies to extend more lives.
New insights from a team led by Duke s Preston Robert Tisch Brain Tumor Center provide potential answers. The team found that recurring glioblastoma tumors with very few mutations are far more vulnerable to immunotherapies than similar tumors with an abundance of mutations.
The finding, appearing online Jan. 13 in the journal ....

David Ashley , Matthias Gromeier , Roelg Verhaak , Allan Friedman , Katherineb Peters , Smitak Nair , Rogere Mclendon , Darelld Bigner , Fredericks Varn , Yeqing Chen , Jamese Herndon , Michaelc Brown , Yannick Desjardins , Xiang Lin , Mustafa Khasraw , Dina Randazzo , Erics Lipp , Henry Friedman , Danip Bolognesi , Allanh Friedman , Frances Mcsherry , Johnh Sampson , Gao Zhang , Junfei Zhao , Henrys Friedman , Duke University School Of Medicine ,