Introgen to study extra data on head and neck cancer therapy

Dec 20 (Reuters) - Introgen Therapeutics Inc INGN.O will seek approval for head and neck cancer therapy Advexin later than planned as the biopharmaceutical company said it decided to study additional late-stage trial data, sending shares down as much as 33 percent to a new year-low.

The company expects to file a Bioligics Licensing Application

(BLA) and Marketing Authorization Application (MAA) for Advexin in the first half of 2008 after studying late-stage trial data, which will include the analysis of additional patient tissue samples that were previously unavailable.

Introgen had earlier expected to conclude the analysis and file for regulatory approval in the United States and Europe for the head and neck cancer indication before the end of 2007.

The decision to study the additional patient tissue samples was based on recommendations by external regulatory and clinical advisors, the company said in a statement.

Advexin is a therapy targeting an abnormal or blocked p53 tumor suppressor function, associated with cancer. Normal p53 suppresses tumors and protects against cancer.

The MAA for Advexin to treat Li-Fraumeni Syndrome -- a genetically inherited disease that increases the risk of developing multiple cancers -- had been accepted for filing by the European Medicines Agency last month under its Exceptional Circumstances rules.

These rules apply to products for which the applicant can demonstrate that comprehensive data cannot be provided, for example because of the rarity of the condition, as long as it can be demonstrated on a regular basis that the benefits outweigh the risks.

Shares of the company, which is also developing a lung cancer therapy, fell to a new year-low of $3.02, before pulling back some of the losses to trade down $1.31 at $3.21 in afternoon trade on the Nasdaq.

(Reporting by Aradhana Aravindan in Bangalore; Editing by Pratish Narayanan)

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