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news.Co-D Therapeutics, a pre-clinical stage pharmaceutical company developing agents for the treatment of cancer, announced that the US Food and Drug Administration (FDA) has granted Co-D's request for orphan drug designation of Triolimus for the treatment of the highly lethal malignancy, angiosarcoma.
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"We are pleased that Triolimus has been designated an orphan drug for the treatment of angiosarcoma," commented Dr. Kevin Kozak, co-founder and Chief Medical Officer of Co-D Therapeutics.
"With few effective options, new agents for angiosarcoma treatment are urgently required. The orphan designation reflects both the FDA’s and Co-D’s commitment to addressing the unmet clinical needs of patients with rare diseases like angiosarcoma."
The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States.
Orphan drug designation will entitle Co-D to seven years of market exclusivity for Triolimus as a treatment for angiosarcoma following marketing approval by the FDA. Additional benefits include tax credits related to clinical trial expenses, potential exemption from the FDA-user fee, assistance in clinical trial design, and smaller trials required for new drug applications.
"The designation of Triolimus as an orphan-drug for angiosarcoma treatment is an early and critical milestone and will facilitate progress through the clinical and regulatory development process," said Abdalla Saad, co-founder and Chief Executive Officer of Co-D Therapeutics.
"We find our preclinical data compelling and are thrilled the FDA judged Triolimus meritorious of orphan-drug designation."
Triolimus technology was developed by Prof. Glen Kwon at the University of Wisconsin-Madison. "We are excited to continue the enormously rewarding process of advancing Triolimus to the clinic," said co-founder and Chief Scientific Officer Prof. Kwon.
Triolimus’ intellectual property portfolio will be licensed from the Wisconsin Alumni Research Foundation (WARF). Funding from WARF’s Accelerator Program supported pre-clinical development of Triolimus.