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Celera files IND for novel cancer inhibitor

02-May-2005

Related topics: Regulatory & Safety

Celera Genomics have filed an Investigational New Drug (IND) application for a novel histone deacetylase (HDAC) inhibitor that has proved effective in inhibiting cancer cell proliferation. The filing also signifies Celera's transformation from selling data to focusing on the realisation of downstream value in targeted medicine.

HDAC inhibitors target HDAC enzymes and inhibit the proliferation of cancer cells and induce cancer cell death, or apoptosis. Celera Genomics recently reported data at the American Association for Cancer Research (AACR) meeting in April 2005, showing the efficacy of CRA-024781 as an HDAC inhibitor in xenograft cancer models.

Celera demonstrated the measurement of tubulin and histone acetylation could be used to monitor the pharmacodynamic effects of CRA-024781 in vivo. Pending clearance by the FDA, Celera Genomics plans to initiate Phase 1 clinical trials.

This latest deal reflects Celera's transition from sequencing the human genome and selling data to focusing on the realisation of downstream value in therapeutics and diagnostics. While the Online/Information Business was important to Celera Genomics in its initial years, it is no longer strategically relevant and has been a source of cash consumption, estimated to be approximately $7 million for fiscal 2005, since many of the subscriptions were prepaid.

A family of related HDAC enzymes carries out histone deacetylation. Inhibition of these enzymes causes changes to chromatin structure and to gene expression patterns, which results in the inhibition of proliferation of cancer cells, and induction of apoptosis.

Celera Genomics published the first three-dimensional structure of an HDAC enzyme in July 2004, and this information has been used to aid the design of a series of novel HDAC inhibitors.

"From the identification of potential biomarkers of efficacy to design and implement our clinical trials, we plan to assess the safety and pharmacokinetics of CRA-024781 in a dose escalation study, at a projected cost of less than $3 million," said Robert Booth, chief scientific officer of Celera Genomics.

Celera Genomics' transformation now sees them with two important strategic assets. Its proteomics platform continues to yield novel cancer targets that have been the focus of several partnerships for drug discovery and development, which contributes to cost effective clinical progression.

Celera Diagnostics is a 50-50 joint venture with Applied Biosystems and is generating substantial product sales and making important discoveries for incorporation into future new products.

With the anticipated discontinuation of the Online/Information Business, Celera Genomics is now in a position to focus its efforts on its most substantial opportunities while managing its use of cash.