Related Experiment Videos
Flavopiridol. National Cancer Institute
1University of North Carolina at Chapel Hill, School of Pharmacy, 27599-7360, USA. hwang@email.unc.edu
Abstract:
Flavopiridol is a synthetic flavonoid inhibitor of cyclin-dependent kinases, which is under development by Aventis Pharma (formerly Hoechst Marion Roussel) and the National Cancer Institute (NCI) for the potential treatment of cancer and proliferative disorders. By May 2001, the product was in phase IIa trials and had achieved proof-of-concept in phase I/IIa trials as a monotherapy. At this time, Aventis expected a global submission to take place in 2003 [409257]. By July 1999, the compound had entered phase II trials for gastric cancer and leukemia, and phase I/II trials for esophageal tumor and non-small cell lung cancer (NSCLC) [277372], [325929], [331850]. Phase II trials for colon and renal cancer [411684], [411769] and phase I trials for prostate cancer [279466] have also been reported. Analysts Merrill Lynch predicted in September and November 2000 that the product would be launched by 2003, with sales of EUR 50 million in that year, rising to EUR 100 million in 2004 [383742], [391426]. In April 1999, ABN Amro predicted annual sales of DM 100 million in 2002 [328676].
Insights
Flavopiridol, a cyclin-dependent kinase inhibitor, is being developed for cancer treatment. Early trials show promise, with potential submissions and sales forecasts indicating future therapeutic and market impact.
Area of Science:
- Oncology
- Pharmacology
Background:
- Flavopiridol is a synthetic flavonoid inhibitor targeting cyclin-dependent kinases.
- It is under joint development by Aventis Pharma and the National Cancer Institute (NCI).
- The drug is intended for treating cancer and proliferative disorders.
Purpose of the Study:
- To evaluate the efficacy and safety of Flavopiridol in various cancer types.
- To establish proof-of-concept for Flavopiridol as a monotherapy.
- To determine the clinical development pathway and market potential.
Main Methods:
- Clinical trials, including Phase I, Phase II, and Phase I/IIa, were conducted.
- Monotherapy efficacy was assessed.
- Developmental progress and regulatory submission timelines were tracked.
Main Results:
- Flavopiridol achieved proof-of-concept in Phase I/IIa trials as a monotherapy.
- By May 2001, the drug was in Phase IIa trials, with global submission anticipated in 2003.
- The compound entered Phase II trials for gastric cancer and leukemia, and Phase I/II for esophageal and non-small cell lung cancer.
Conclusions:
- Flavopiridol demonstrated potential as a monotherapy for various cancers.
- Clinical development progressed through multiple phases across different cancer types.
- Market forecasts suggested significant commercial potential by the early 2000s.