Astex Therapeutics Receives FDA Approval for Clinical Development of AT9283

Astex Therapeutics has announced the approval of its Investigational New Drug (IND) application for the clinical development of its proprietary Aurora Kinase inhibitor, AT9283, for the treatment of cancer. This second IND approval in less than 12 months marks a significant milestone for the company, which has been leveraging its fragment-based drug discovery platform, Pyramid, to develop novel molecularly targeted cancer drugs.

As a potent inhibitor of the Aurora A and B kinases, AT9283 has shown promising results in arresting tumor growth in various tumor models. The approval of AT9283's IND application paves the way for the initiation of a phase I clinical trial at a leading oncology center in the United States. The study aims to evaluate the safety and efficacy of AT9283 in patients with hematological cancers, with additional studies planned in North America and Europe in the second half of the year.

Key Takeaways:

Astex Therapeutics has received FDA approval for the clinical development of its proprietary Aurora Kinase inhibitor, AT9283, for the treatment of cancer.
AT9283 was discovered and developed internally using Astex's fragment-based drug discovery platform, Pyramid.
This is Astex's second IND approval in less than 12 months, following the approval of its lead compound AT7519, which is currently in phase I trials in the U.S. and U.K.
AT9283 is a potent inhibitor of the Aurora A and B kinases and has shown promising results in arresting tumor growth in various tumor models.
Astex's current products have been discovered internally using its proprietary drug discovery approach, highlighting the company's productivity in generating novel molecularly targeted cancer drugs.
Harren Jhoti, chief scientific officer and acting chief executive of Astex, stated, "We are delighted to have been given the go-ahead by regulatory authorities to advance AT9283 into clinical development. We are now putting the final preparations in place to begin this first clinical trial of AT9283 in the coming weeks."
Astex plans to initiate additional studies in North America and Europe in patients with solid tumors during the second half of the year.

Statistics:

Astex Therapeutics has received its second IND approval in less than 12 months for AT9283.
AT9283 is the second most progressed drug candidate in the Astex portfolio of novel molecularly targeted cancer drugs.
Both Aurora A and B kinases are over-expressed in many human tumors, making them excellent targets for anti-cancer therapy.
AT9283 has been shown to arrest tumor growth in a range of tumor models.

Sources:

Astex Therapeutics press release