Developing Innovative Cancer Therapies That Extend Lives
TriAct is a private, Approval and Phase 3 stage cancer therapeutics Company, co-founded and lead by an experienced industry team with a track record of delivering both patient and shareholder value. They are developing a portfolio of promising new cancer therapies
Date & Time:
July 28, 12:00 PM EDT
Webinar: Details provided upon RSVP approval
About the Event:
Iniparib, the company’s lead drug has demonstrated clinical benefit in seven phase 2 and 3 clinical trials to date. TriAct is meeting with the FDA late 3rd quarter 2020 to request accelerated approval for Iniparib to treat newly diagnosed glioblastoma patients.
- The FDA created the AA pathway to speed the approval process for new drugs that treat serious or life-threatening conditions…and that provide a meaningful advantage over existing, approved therapies
- FDA has granted 7 accelerated approvals in the first half of 2020 based on small phase 2 clinical trial results
TriAct is preparing to file its new drug application (NDA) for glioblastoma in December 2020. This approval will trigger a 2021 market launch.
Glioblastoma is the most common and aggressive form of brain cancer and is responsible for nearly 20,000 deaths in the United States every year. Those who have died recently from glioblastoma include John McCain, Ted Kennedy and Beau Biden.
There have been no meaningful new therapies approved since 2005 for glioblastoma. TriAct’s phase 2 clinical results show a significant increase in median overall survival, 2 year survival and 3 year survival when Iniparib is added to the current standard of care. Iniparib has also been shown to be safe and well tolerated across multiple trials, treating over 2,500 patients.
TriAct’s patent portfolio provides competitive protection through 2038. TriAct also intends to apply for FDA orphan drug status which will give Iniparib 7 years of market exclusivity in glioblastoma.
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