Astex Receives FDA Approval for Investigational New Drug AT7519

Astex, a fragment-based drug discovery and development company, has achieved a significant milestone with the approval of its Investigational New Drug (IND) application for the clinical development of its proprietary cell cycle inhibitor, AT7519, for the treatment of cancer. This approval marks a major breakthrough for Astex, allowing the company to proceed with a multicenter phase I trial of AT7519 in patients with refractory solid tumors in the U.S. and the U.K. The IND approval is a result of Astex's internal development using its fragment-based drug discovery platform, Pyramid, which has enabled the company to progress from first synthesis to regulatory approval in an impressive 14 months.

Key Takeaways:

• Astex has received FDA approval for its Investigational New Drug (IND) application for AT7519, a proprietary cell cycle inhibitor for the treatment of cancer.
• AT7519 was discovered and developed internally using Astex's fragment-based drug discovery platform, Pyramid.
• The phase I study will be conducted at multiple locations, including the Arizona Cancer Center and the Northern Institute for Cancer Research at the University of Newcastle upon Tyne.
• Astex's chief scientific officer, Harren Jhoti, has announced the company's plans to begin the clinical trial of AT7519 in the coming weeks.
• The IND approval closely follows the Clinical Trial Authorisation (CTA) application approval by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).
• The phase I study will be directed by Daniel Von Hoff and Daruka Mahadevan at the Arizona Cancer Center and professor Hilary Calvert at the Northern Institute for Cancer Research.
• AT7519 has shown promise in cancer treatment, with Astex's internal development and testing marking a significant achievement in the field.

Statistics:

• 14 months: the time it took Astex to progress from first synthesis to regulatory approval for AT7519.
• 2 countries: the U.S. and the U.K. where the phase I trial of AT7519 will be conducted.
• 2 locations: the Arizona Cancer Center and the Northern Institute for Cancer Research at the University of Newcastle upon Tyne, where the phase I study will take place.
• 3 experts: Daniel Von Hoff, Daruka Mahadevan, and professor Hilary Calvert, who will direct the phase I study.
• 1 company: Astex, the fragment-based drug discovery and development company behind the development of AT7519.

Sources:

• Health & Medicine Week
• NewsRx.com
• Astex