"Obtaining orphan designation for marizomib in the EU for multiple myeloma represents an important milestone in the development of this novel, highly potent proteasome inhibitor," said
EMA's Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. In addition to 10 years of market exclusivity, the designation also provides special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.
Triphase is currently evaluating the IV formulation in an ongoing Phase II clinical trial in combination with dexamethasone in a highly refractory multiple myeloma population, including those refractory to carfilzomib; it is also being tested in a Phase I study in combination with pomalidomide and dexamethasone in relapsed and refractory multiple myeloma. Triphase is evaluating an oral formulation of marizomib in IND-enabling studies. About Multiple Myeloma Multiple myeloma is a hematologic cancer in which plasma cells, a type of white blood cell made in the bone marrow, become cancerous, multiply too quickly and accumulate throughout the body. The accumulation of these cancerous plasma cells can form tumors in bones throughout the body. Multiple myeloma can prevent the bone marrow from making sufficient quantities of healthy red blood cells, white blood cells and platelets, which can severely weaken the bones and immune system.
Worldwide, an estimated 750,000 people are living with multiple myeloma. An estimated 103,000 new cases are diagnosed annually, accounting for about 1 percent of all cancers diagnosed and 12 percent of all hematologic cancers diagnosed. About Triphase Triphase is a private drug development company with a primary focus on oncology and operations in
Keywords for this news article include: Cancer, Therapy, Oncology, Marketing, Advertising, Blood Cells,
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