On July 7, 2021 TriAct Therapeutics, a private, late clinical stage oncology therapeutics company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug, iniparib, for the treatment of patients with malignant gliomas (Press release, TriAct Therapeutics, JUL 7, 2021, View Source [SID1234584670]). The FDA noted that the designation granted is broader than the glioblastoma indication proposed in the Company’s request and that treatment of glioblastoma is within the scope of this orphan drug designation.

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The mission of the FDA Office of Orphan Products Development (OOPD) is to advance the development of products that demonstrate promise for the treatment of rare diseases which affect fewer than 200,000 people in the United States. Orphan drug designation entitles iniparib, once approved by the FDA, to seven years of market exclusivity in treating patients with malignant glioma. Additional incentives for orphan drug development include tax credits related to development expenses, a reduction in FDA user fees and FDA assistance in clinical trial design.

"Receiving orphan drug designation is an important milestone in our effort to bring this promising new therapy to both adult and pediatric patients suffering from malignant gliomas, including newly diagnosed glioblastoma," said Tom White, co-founder and Chief Executive Officer of TriAct. "With a three-year survival rate of 16% for newly diagnosed glioblastoma patients, this designation is also an acknowledgement of the urgent need to intelligently but expeditiously develop promising new therapies for these patients. Consequently, following FDA guidance from our end-of-phase 2 meeting earlier this year, we are also filing for Fast Track designation."

About Iniparib

Iniparib is a well characterized, clinical stage drug candidate that kills cancer cells by targeting their redox metabolism, spiking oxidative stress levels and triggering programmed cell death. Iniparib’s Phase 2 Study in newly diagnosed glioblastoma patients met its primary survival and safety end points. Based in part on these promising results TriAct is designing a pivotal trial intended to support submission of an NDA in the U.S. and MAA in Europe.

About Newly Diagnosed Glioblastoma

Glioblastoma (GBM) tumors are the most common and aggressive form of brain cancer, affecting approximately 15,000 patients annually in the United States (US). Annual incidence of GBM in the US is approximately 3 per 100,000 population. The standard of care since 2005 in the US comprises surgical resection of the tumor followed by adjuvant radiotherapy combined with temozolomide (TMZ), and subsequent maintenance TMZ. Currently, survival for GBM patients is poor, with approximately 75% of patients dying within 2 years of diagnosis and 95% dying within 5 years