In Phase 2 and 3 Trials With A Potential Treatment for Multiple Cancers
Date & Time:
September 29, 3:00 PM GMT / 11:00 AM EDT
Webinar: Details provided upon RSVP approval
About the Event:
TriAct Therapeutic’s lead drug, Iniparib, 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.
All statements and expressions are the sole opinion of the company and are subject to change without notice. The Company is not liable for any investment decisions by its readers or subscribers. It is strongly recommended that any purchase or sale decision be discussed with a financial advisor, or a broker-dealer, or a member of any financial regulatory bodies. The information contained herein has been provided as an information service only. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. Investors are cautioned that they may lose all or a portion of their investment in this or any other company. Information contained herein contains “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act of 1934, as amended. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical facts and may be “forward looking statements”. Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements may be identified through the use of words such as “expects”, “will”, “anticipates”, “estimates”, “believes”, or by statements indicating certain actions “may”, “could”, “should” or “might” occur.